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 22 March 2018

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Peter B. Cotton

5. Management of postsurgical bile leaks and bile duct strictures

Jacques J. G. H. M. Bergman

Top of page Synopsis  Next section

Although most centres performing laparoscopic cholecystectomy may now be well beyond the 'learning-curve' phase, the incidence of postsurgical bile duct injuries will probably stay higher than in the era before laparoscopic cholecystectomy. In addition, with surgeons embarking on more complex laparoscopic biliary interventions, such as laparoscopic duct exploration, a further increase in the incidence of surgical bile duct injuries may be expected in the near future. Adequate management of these injuries requires an early postoperative diagnosis with a low threshold for performing an ERCP.

Patients with a complete ductal transection require an elective surgical repair, 6–8 weeks after diagnosis and drainage. Most of the other bile duct injuries (minor leaks from the cystic stump or peripheral hepatic radicals, major bile duct leaks, and isolated bile duct strictures) can in general be managed endoscopically.

Patients who require long-term stenting for bile duct strictures should be treated with at least two 10 Fr plastic stents that are electively exchanged every 3 months. If possible, more than two stents should be inserted. There is currently no place for self-expandable metal stents for this indication.

Optimal management of patients with bile duct injuries requires a multidisciplinary team approach of interventional radiology, therapeutic endoscopy, and reconstructive surgery.

Top of page Introduction  Previous section Next section

The majority of surgical bile duct injuries occur during cholecystectomy, but any surgical procedure involving the liver and/or bile ducts may cause these lesions. Over the last decade laparoscopic cholecystectomy has gained widespread acceptance among surgeons and the public and has replaced conventional 'open' cholecystectomy as treatment of choice for symptomatic cholecystolithiasis. Compared with 'open' cholecystectomy, laparoscopic cholecystectomy is associated with less postoperative pain, shorter stay in hospital and recovery, earlier return to work, and a better cosmetic outcome [1]. Laparoscopic cholecystectomy does, however, carry an increased risk for biliary tract injury [2]. These injuries occur in 0.2–0.5% of patients undergoing open cholecystectomy and in 0.5–2.7% after laparoscopic cholecystectomy [3–6]. The injury often results from poorly defined anatomy or from attempts to stop hilar bleeding by means of clipping or thermal devices. Besides direct injury due to clipping and diathermy, delayed injury may arise from ischemia of the bile ducts [7]. The presence of acute cholecystitis, and a low case volume of the surgeon, are accepted risk factors for bile duct injury during laparoscopic cholecystectomy [8,9]. Intraoperative cholangiography does not seem to reduce the frequency of these complications [9]. Management of patients with postsurgical bile duct injuries requires a multidisciplinary approach of radiologists, endoscopists, and surgeons. In general, multiple invasive procedures are required and, although the functional outcome is usually good, postsurgical bile duct injuries have a marked influence on the patients' physical and mental quality of life, even at long-term follow-up [10].

Top of page Classification of bile duct injuries  Previous section Next section

In general, four types of bile duct injury can be recognized.

  • Type A Cystic duct leaks or leakage from aberrant or peripheral hepatic radicles (Figs 1 and 2).
  • Type B Major bile duct leaks with or without concomitant biliary strictures (Figs 3 and 4).
  • Type C Bile duct strictures without bile leakage (Figs 4 and 5).
  • Type D Complete transections of the duct with or without excision of some portion of the biliary tree (Fig. 6) [11].

Presentation  Previous section Next section

The majority of bile duct lesions during cholecystectomy are not recognized during the procedure. The postoperative clinical presentation varies widely and is mainly influenced by the type of injury [11]. The diagnosis is usually straightforward in patients with an isolated ductal stricture (type C). These lesions present with jaundice, cholestatic liver function tests, and dilated bile ducts on ultrasound and have a relatively long symptom-free interval after the cholecystectomy (median of 2 months in our series) [11]. In contrast to isolated strictures, bile leaks due to minor bile duct lacerations (type A lesions), major bile duct lacerations (type B lesions), or complete transections (type D lesions), present in a less uniform way. Here, symptoms are frequently absent or non-specific in the early postoperative phase (general malaise, low grade fever, marginally increased liver function tests). However, the patient's clinical condition may rapidly deteriorate after 3–5 days when ileus, peritonitis, and sepsis develop. Early aggressive investigation in patients with diffuse abdominal pain, fever, malaise, or liver function abnormalities after laparoscopic cholecystectomy is therefore mandatory [12,13].

Top of page Diagnostic protocol  Previous section Next section

The first step is to perform an abdominal ultrasound to investigate the presence of ductal dilatation or fluid collections [14]. Biliary dilatation is often absent (in our series in 71% of cases) [11] because the biliary system is decompressed by the leak. In the event of fluid collections, percutaneous needle aspiration may differentiate an abscess from a biloma [15]. When ductal dilatation is present or needle aspiration yields bile, an ERCP should be the next diagnostic procedure [11]. At ERCP, care should be taken that the whole biliary system is visualized. Bile leaks associated with the anatomical variant of a low-inserting right segmental hepatic duct can be particularly difficult to diagnose and ERCP results are often interpreted falsely as 'normal', with no leaks demonstrated (Fig. 7).

Top of page Management of bile duct leakage after cholecystectomy  Previous section Next section

Spontaneous resolution of bile leakage has been described in patients with external drains [16]. Some have therefore advocated a 'wait-and-see' policy in these patients and this seems justified in clinically stable patients without evidence of sepsis or peritonitis. However, if percutaneous bile leakage persists or the patient's clinical condition deteriorates, an ERCP is indicated. This will establish the diagnosis in all patients with types A, B, and C lesions and will allow for effective therapeutic intervention in most of them [11].

Type A injury (peripheral leaks)  Previous section Next section

Patients with bile leakage from the cystic duct or peripheral hepatic radicles are treated by insertion of a short biliary stent to lower the pressure of the biliary system by bypassing the biliary sphincter (Fig. 8). The stent is preferably inserted without endoscopic sphincterotomy unless this is necessary to extract bile duct stones or gain biliary access. Endoscopic treatment is effective in 90% of the patients with type A lesions, although 15–20% will require additional percutaneous drainage of a biloma[11]. Insertion of a stent does give the patient the burden of a second endoscopic intervention for removal of the stent but prevents a sphincterotomy that may cause acute and late complications. Placement of a nasobiliary tube is another option in treating leakage from minor bile ducts: closure of the leak can be monitored by repeating cholangiography, low pressure suction can be applied, and drain removal does not require an additional endoscopy [17,18]. However, nasobiliary tubes are not well tolerated by patients and long-term drainage may require recirculation of bile to prevent electrolyte disturbances [19].

Type B injury (main duct leaks)  Previous section Next section

Bile leakage from major bile ducts may be more challenging to treat endoscopically. Extensive duct damage and leakage can make it difficult to pass a guidewire into the proximal biliary system (Fig. 9). The presence of clips and stenoses (due to inflammatory reactions in the hepatoduodenal ligament) may also hamper passage into the proximal hepatic system or insertion of stent. In case ERCP fails, PTC and rendezvous procedure should be the next step (Fig. 10). Endoscopic treatment is successful in approximately 75% of patients with leakage from major bile ducts [8,11,20]. An important late complication of bile leakage from major bile ducts is a secondary stenosis at the site of the leak (Fig. 4). Insertion of a stent not only adequately seals the bile leakage but also allows for prevention or treatment of secondary ductal stenosis.

Type C injuries (postoperative biliary strictures)  Previous section Next section

Most postoperative bile duct strictures are short (less than 10 mm in length) and situated distal to the confluence of right and left hepatic ducts. Postoperative strictures are usually classified according to Bismuth by their position relative to the hepatic confluence [23].

Options for therapy include surgery, percutaneous balloon dilation and stenting, and endoscopic stenting, if necessary combined with balloon dilation. The different treatment options will be discussed below.

Type D injury (transections)  Previous section Next section

Patients with complete transection of the bile duct are not amenable to endoscopic treatment because the distal and proximal biliary systems are not in continuity (Fig. 6). These patients should undergo reconstructive surgery: Roux-en-Y-hepaticojejunostomy is the procedure of choice. The outcome of surgical management of these lesions is influenced by a variety of factors including: proximal extent of the injury, type of reconstructive procedure performed, experience of the performing surgeon, timing of intervention, presence of proximal dilation and local inflammation at the time of the procedure, condition of the patient, and the length of follow-up. The timing of the procedure is a key factor determining the outcome of reconstructive surgery.

Delayed reconstruction  Previous section Next section

We observed that early complications and late anastomotic stenoses occurred in 80% of patients treated with early reconstructive surgery whereas these complications were observed in only 17% of patients who underwent elective surgery after 8–12 weeks [11]. Reconstructive surgery in the acute postoperative phase, often started as a diagnostic procedure in a patient with peritonitis, ileus, or sepsis, is at risk for leakage and stenosis because of the absence of proximal dilatation and the presence of severe inflammatory changes of the tissue. Adequate drainage for 8–12 weeks through percutaneously placed drains allows for the acute local inflammatory reaction to subside and enables the surgeon to establish the exact proximal extent of the injury before surgery [21]. In most patients a percutaneous transhepatic cholangiography and drainage (PTCD) is performed for this purpose and to delineate the proximal anatomy prior to the reconstruction [22]. The biliary system in these patients is often not dilated because it is decompressed by leak. A PTC may therefore be technically difficult and one may choose to drain the biloma by subhepatic and/or abdominal drains and to use MRCP and/or fistulography through these drains to delineate the proximal extent of the injury (Fig. 7).

Top of page Surgical treatment of postoperative biliary strictures  Previous section Next section

The outcome of surgery for benign biliary strictures is good in 75–93% of patients [21,24,25]. The treatment of choice is usually a Roux-en-Y-hepaticojejunostomy. Anastomotic strictures develop later in approximately 20% of patients [24,26], and when a subsequent repair is undertaken, a further recurrence develops in 26% [27,28]. The majority of anastomotic stenoses develop within 7 years of surgery [28]. Reported surgical mortality rates are in the range of 3.2–27%, the higher rate being related to patients with coexisting pathology such as portal hypertension [24,25,27]. Factors that are associated with a favorable outcome include greater distance from the hepatic confluence, early referral, no previous repair, and the quality of the proximal duct.

It is important to note that there are only a few reports on surgical treatment of patients with postoperative biliary strictures, and that most reports describe surgical treatment of more than a decade ago. Since then, surgeons have benefited by the improvement in endoscopic and invasive radiographic techniques. Nowadays ultrasound, CT-scanning, ERCP, and PTC provide surgeons with accurate preoperative information and allow for the optimal timing of the reconstructive procedure. Combined with improved surgical techniques, this may have resulted in an improved outcome of surgical treatment. Lillemoe et al. [22] have reported on a series of 156 patients undergoing surgical reconstruction for postoperative bile duct strictures. Two patients died of unrelated disease before completion of treatment, 12 patients had biliary stents in place at the time of the report. Of the 142 patients who completed treatment (mean follow-up 58 months) 91% were considered to have a successful outcome without the need for further interventional procedures.

Top of page Percutaneous treatment of postoperative strictures  Previous section Next section

Percutaneous dilation via transhepatic puncture or T-tube has an associated morbidity of less than 7% [29], but the reported success rates vary widely from 33 to 100% [29,30]. In general, percutaneous therapy requires several sessions to obtain a satisfactory outcome. In our hospital, patients undergo a PTC on the first day to obtain a diagnostic cholangiogram and to decompress the biliary system. The next day a percutaneous balloon dilatation (8–10 mm balloon) is performed and an internal–external PTC-drain is inserted through the anastomosis. This drain is left in situ for 6 weeks and then removed after a second balloon dilatation procedure. Misra et al. recently reported their results in 51 patients. The success rate of percutaneous management without the need for subsequent interventions was 59% [31].

The major concerns with the transhepatic approach are the attendant risks of hemorrhage and bile leakage associated with liver puncture. Additionally, two-thirds of patients may have a non-dilated biliary tract, making ductal puncture technically difficult [32]. A further disadvantage is the requirement for long-term transhepatic intubation. In our unit, the percutaneous approach is mainly reserved for patients with postsurgical anastomotic stenoses (usually after hepaticojejunostomy) and as part of a rendezvous procedure with ERCP after failed prior endoscopic approach (Fig. 10).

Top of page Endoscopic treatment of postoperative biliary strictures  Previous section Next section

Endoscopic management of patients with postoperative biliary strictures comprises endoscopic balloon dilation, placement of biliary stents, or a combination of the two.

Endoscopic balloon dilation can be performed with 4–8 mm diameter balloons that are passed over a prepositioned guidewire (Fig. 11). In case of very tight strictures, dilating catheters can be used to facilitate advancement of the balloon catheter. Under fluoroscopic control the balloons are then inflated to 4–10 atmospheric pressures. The optimum duration of the maximum insufflation and the number of dilation cycles during one procedure are not well established. Usually balloon dilation does not result in complete disappearance of the waist in the balloon at the first procedure and thus multiple procedures are necessary for radiological resolution. Some preliminary data for endoscopic balloon dilation alone appeared favorable, but this was not confirmed in other studies [33].

Reported results  Previous section Next section

Many reports have been published on the outcome of endoscopic treatment in patients with postoperative strictures, but it is difficult to extrapolate general figures for success and complication rates and to determine what factors influence these outcome parameters. Virtually all series are retrospective single-center reports on treatment of a heterogeneous group of patients: isolated strictures and leaks, different mixtures of Bismuth localizations, with or without secondary cirrhosis at the time of treatment, with and without prior treatment before referral to expert centers, etc. Most series have included patients during a period of many years in which endoscopic protocols have changed. Many studies, therefore, describe study populations that have not been uniformly treated. Series with a relatively short follow-up period may reliably report early success and complication rates but will lack the rate of restenosis after stent removal. For this, long-term follow-up studies are required but these may suffer from the same drawbacks as the aforementioned antiquated surgical reports (e.g. the rate of early complications may be an overestimation of the current practice). In Fig. 14 the different phases of endoscopic management of postoperative bile duct stenoses are shown, as well as the outcome parameters of interest. This flow-chart should preferably be used as guidance for further reports on the endoscopic management of patients with postoperative bile duct stenoses.

An early study by our group found that a combination of balloon dilation and insertion of a 10 Fr polyethylene stent, yielded satisfactory results in 21 of 27 patients during a follow-up period of 18 months [34]. Other investigators obtained similar results with this combination therapy [33,35–38]. The standard endoscopic technique nowadays involves placement of usually two stents during a maximum treatment period of 12 months (Figs 12 and 13). To prevent cholangitis due to clogging stents are exchanged at 3 month intervals. The treatment protocol therefore consists of three phases: a stent insertion phase, a stenting phase with stents in situ and trimonthly stent exchange, and a follow-up phase after removal of the stents (Fig. 14).

One of the most comprehensive studies comes from Dumonceau and colleagues, who treated 48 patients with postoperative biliary strictures [39]. Endoscopic dilation of the strictures by means of dilating catheters or balloons was successful in 47 (98%). Four patients had self-expandable metal stents inserted and 43 received plastic stents that were electively exchanged every 6 months. Complications occurred in 6/48 patients (13%) after the initial ERCP. Stenting was maintained for a mean of 8.3 months (0.3–32 months) during which complications occurred in 20% of patients (mainly cholangitis or mild fever after elective stent exchange). Five patients discontinued the stenting phase but in only one patient was this due to complications. In 38 patients the endoscopic treatment was completed: 36 had stricture dilation judged satisfactory during a stent exchange and had no new stents inserted. In two patients plastic stents were replaced by Wallstents. After removal of the stents, the 36 patients were followed up for a mean period of 44 months (1–130 months). In 7 patients (19%) the strictures recurred, with all but one of these occurring within 1 year of stent removal.

Our group has performed a retrospective analysis of 63 patients with incomplete biliary strictures [40]. Stent insertion was successful in 59 (94%). After the initial ERCP early complications occurred in 13 patients (20%), whereas 19 patients (33%) suffered from complications during the stenting phase (mainly cholangitis). Stents were eventually removed in 44 patients after a median period of 12 months (3–37 months). During a median follow-up period of 109 months (2–180 months) restenosis occurred in 9 patients (20%) and all cases of restenosis occurred within 2 years of follow-up.

In Fig. 15 the results of endoscopic treatment of postoperative biliary strictures are summarized.

Phases of endoscopic treatment  Previous section Next section

Stent insertion phase  Previous section Next section

Stent insertion is successful in about 95% of patients with incomplete ductal strictures [39,40]. In patients with a total ductal obstruction endoscopic treatment is not possible. Since an ERCP is required to make this diagnosis, these patients are inevitably failures of endoscopic treatment. In a strict sense these patients do not have a true stenosis and most studies have therefore limited the inclusion to patients with incomplete ductal stenosis [39,41]. Early complications are mainly sphincterotomy-related or reflect the patient's condition (e.g. pre-existent fever in case of bile leakage). Dumonceau et al. reported early complications in 6 of their 48 patients (12.5%) whereas Costamagna observed 4 complications in 45 patients (9%) [41]. In our series an early complication rate as high as 19% was observed. This study, however, was performed to evaluate the long-term outcome of endoscopic treatment, and patients were treated 10–15 years ago [40]. With the current endoscopic standards, early complications should not be observed in more than 10% of patients.

Stenting phase  Previous section Next section

Since the stenting period covers a period of up to 1 year, complications are not uncommon (33% and 20% in the aforementioned studies, respectively). Dumonceau et al. used an interval of 6 months between elective ERCPs and this may be too long given the average time to stent occlusion as reported in other studies [39]. In our retrospective study, complications during the stenting period mainly occurred in patients in whom the patients and/or referring physicians did not adhere to treatment protocol [40]. Many years have passed since then, and the endoscopic treatment of patients with benign biliary strictures has become more accepted. Currently, in patients in whom elective trimonthly ERCPs are performed, complications due to stent dysfunction are mild and occur at a maximum of 10–15% during a stenting period of 1 year. With this regimen 90–95% of patients will have their stenosis adequately dilated within 1 year.

Follow-up phase  Previous section Next section

Studies have reported a recurrence rate of 20% after removal of the stents [39,40]. In the series of Dumonceau et al. 36 patients were followed for a mean period of 44 months after removal of the stents, whereas our group followed 44 patients for a median period of 9.1 years after stent removal. It is important to note that almost all cases of restenosis occurred relatively early after removal of the stents: only one patient was diagnosed with recurrent stenosis after more than 6 months and all cases occurred within 2 years of stent removal. This suggests that endoscopic treatment of postsurgical stenoses is not associated with a high rate of long-term restenosis after stent removal, as suggested by antagonists of this treatment regimen. This is in contrast to the anastomotic recurrences after hepaticojejunostomy, which may occur after many years [28]. It also implies that strict follow-up after stent removal is necessary, especially during the first 6–12 months in order to diagnose restenosis at an early stage.

It is important to note that, apart from recurrence of the initial stenosis, other late complications may also occur after stent removal, e.g. cholangitis from bile duct stones or symptoms associated with (pre-existing) liver failure [40,41]. Bile duct stones may develop because of impeded bile flow due to a relative stenosis; however, since all patients initially underwent biliary surgery for stone disease, the underlying stone disease may also be held responsible [42].

Top of page Postoperative biliary strictures: surgery or endoscopy [43]?  Previous section Next section

Prospective randomized studies comparing surgical and endoscopic treatment of postoperative biliary strictures are not available. We have performed a retrospective study comparing surgical with endoscopic therapy (Fig. 16) [26]. Both approaches were found to have a similar long-term success rate, with recurrences being seen in 17% of patients.

Since there appear to be no clear differences in the primary outcomes between surgical and endoscopic management, the choice between the two is determined by other factors: the two most important ones are different characteristics of restenosis, and patients' preference.

Recurrent strictures after surgery  Previous section Next section

The diagnosis of anastomotic stenosis after hepaticojejunostomy may be difficult since most patients already have mild liver function abnormalities and dilatation of the biliary tree on ultrasound is often absent [44]. After Roux-en-Y-hepaticojejunostomy, endoscopic approach to the biliary tree is usually not possible. Most physicians are reluctant to perform a PTC in these patients because of the risk of hemorrhage and bile leakage, especially in case of non-dilated bile ducts [32]. In patients with prior endoscopic treatment of bile duct strictures, diagnosis of recurrent stenosis is easier, safer, and therefore associated with less medical delay (which may cause secondary biliary cirrhosis). Furthermore, restenosis after endoscopic treatment occurs relatively early after stent removal (less than 1–2 years) [40,45] whereas anastomotic recurrences after surgery may develop after more than 10 years [28].

Treatment of recurrent stenosis after hepaticojejunostomy involves either percutaneous balloon dilation, often supplemented with internal–external stenting, or repeated surgery. Nowadays, most patients with anastomotic stenosis are initially managed by percutaneous treatment, but multiple sessions are often required and the cumulative morbidity due to bleeding and bile leakage may be as high as 30%. Repeat surgery will eventually be required in 20–30% of these patients. Compared to primary hepaticojejunostomy, repeated reconstructive surgery is associated with a higher complication and failure rate [27,28].

Whereas endoscopic treatment is impossible once a Roux-en-Y loop has been constructed, prior endoscopic treatment does not preclude further surgical treatment. In addition, recurrent strictures after prior endoscopic therapy can also be successfully treated by repeated stenting. Finally, although endoscopic treatment requires multiple ERCPs, many patients and their referring doctors prefer endoscopic treatment to surgery.

Therefore, we feel that surgery should be reserved for patients with failed endoscopic therapy or for patients who refuse endoscopic therapy.

Top of page Metal stents for benign strictures  Previous section Next section

The use of metal expandable stents in benign biliary disease remains controversial. Initially, several groups reported favorable results in the management of postoperative strictures. Gianturco–Rösch Z stents were placed percutaneously in 43 such patients by Coons [46]. All patients had previously undergone an unsuccessful balloon cholangioplasty. The 1-year reocclusion rate was 13%. Maccioni et al. report long-term patency in 100% in patients with a CBD stricture [47]. Foerster et al., reporting on endoscopic Wallstent placement in four patients, identified no stent-related complications and no cases of occlusion during a follow-up period of 53 weeks [48]. More recent follow-up studies, however, have obtained less satisfactory results. Hausegger et al. reported that the patency rate rapidly decreased to 19% at 57 months follow-up [49]. Dumonceau et al. reported a 100% occlusion rate of Wallstents inserted in six patients with postoperative strictures within 48 months of follow-up [45]. Lopez et al. reported a good clinical result, arbitrarily defined as the need for two or fewer invasive interventions, in only 5 out of 15 patients. The remaining 10 patients underwent multiple interventions, including surgery in five with a poor general outcome [50].

Studies in dogs have demonstrated marked bile duct narrowing related to extensive fibrosis after insertion of Wallstents but only minimal changes after insertion of plastic or covered metal stents [51]. An important disadvantage of metallic stents is that they cannot be removed once they become obstructed. Because of these results we do not advise inserting metallic stents in this context. The advent of removable expandable stents may, however, alter this situation in the future [52].

Top of page A more aggressive treatment protocol?  Previous section Next section

Currently, the standard protocol for patients with benign strictures involves placement of two stents during a maximum treatment period of 12 months. Recently, a more aggressive treatment protocol has been suggested in which there is no maximum period of stenting and as many stents as possible are inserted in order to obtain maximum dilatation. Costamagna and colleagues treated 45 patients with such an aggressive protocol [41]. They inserted as many stents as possible according to the downstream duct diameter (Fig. 17). Endoscopic treatment was discontinued only if the stricture was considered to be adequately dilated on fluoroscopy. A mean number of 3.2 stents were inserted (range 1–6 stents) for a mean duration of 12 months (range 2–24 months). Forty-two patients completed the treatment protocol; all stenoses resolved and none of the 42 patients suffered from restenosis during a median period of follow-up of 29 months (range 24 months to 11.3 years). These impressive results suggest that a more prolonged and aggressive endoscopic approach may be justified in more difficult cases.

Top of page Conclusions  Previous section Next section

Although most centres performing laparoscopic cholecystectomy may now be well beyond the 'learning-curve' phase, the incidence of postsurgical bile duct injuries will probably stay higher than in the era before laparoscopic cholecystectomy. In addition, with surgeons embarking on more complex laparoscopic biliary interventions, such as laparoscopic duct exploration, a further increase in the incidence of surgical bile duct injuries may be expected in the near future. Adequate management of these injuries requires an early postoperative diagnosis with a low threshold for performing an ERCP. Patients with type D lesions (complete ductal transection) require an elective surgical repair, 6–8 weeks after diagnosis and drainage. Most of the other bile duct injuries (minor leaks from the cystic stump or peripheral hepatic radicals, major bile duct leaks, and isolated bile duct strictures) can in general be managed endoscopically.

Patients who require long-term stenting for bile duct strictures should be treated with at least two 10 Fr plastic stents that are electively exchanged every 3 months. If possible, more than two stents should be inserted. There is currently no place for self-expandable metal stents for this indication.

Optimal management of patients with bile duct injuries requires a multidisciplinary team approach of interventional radiology, therapeutic endoscopy, and reconstructive surgery.

Top of page Outstanding issues and future trends  Previous section Next section

Most controversies connected to the management of postsurgical bile duct lesions relate to the treatment of biliary stenoses. There are still many questions concerning the optimal endoscopic management of these patients. Should stent placement always be preceded by balloon dilation? How many stents should be inserted? What is the optimal period of stenting? Some groups treat patients only for a relatively short time (e.g. 6 months) before deciding on success or failure. Others do not have a maximum period of stenting and attempt to insert as many stents as possible in order to obtain maximum dilatation.

With such an aggressive endoscopic treatment protocol, however, the question arises of what the long-term effects of stenting are on the biliary system. Studies using intraductal ultrasonography have shown that stenting induces profound thickening and fibrosis of the bile duct wall that occurs as short as 2 weeks after insertion of a single plastic endoprosthesis [53]. Placing multiple stents for a period of over 1 year might thus reduce the chances of a successful surgical reconstruction in case endoscopic treatment should fail. In the near future, use of biodegradable self-expandable stents that gradually dissolve after 1–2 years, or insertion of covered self-expandable stents that can be removed, might be options.

Which subset of patients will most likely benefit from endoscopic management? The impression exists that patients in whom the stricture is diagnosed relatively early after surgery have a better prognosis than patients who present a long time after surgery, but this has not been substantiated in follow-up studies. Patients with more proximal lesions are more difficult to treat and some experts have advised primary surgical treatment in patients with hilar strictures [54]. Multivariate analysis of large cohorts of patients will be necessary to solve these issues.

Top of page References  Previous section

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24 Raute, M, Podlech, P & Jaschke, W et al. Management of bile duct injuries and strictures following cholecystectomy. World J Surg 1993; 17 (4): 553–62. PubMed

25 Chapman, WC, Halevy, A & Blumgart, LH et al. Postcholecystectomy bile duct strictures: management and outcome in 130 patients. Arch Surg 1995; 130 (6): 597–602. PubMed

26 Davids, PH, Tanka, AK & Rauws, EA et al. Benign biliary strictures. Surgery or endoscopy? Ann Surg 1993; 217 (3): 237–43. PubMed

27 Genest, JF, Nanos, E & Grundfest-Broniatowski, S et al. Benign biliary strictures: an analytic review (1970–84). Surgery 1986; 99 (4): 409–13. PubMed

28 Pitt, HA, Miyamoto, T & Parapatis, SK et al. Factors influencing outcome in patients with postoperative biliary strictures. Am J Surg 1982; 144 (1): 14–21. PubMed CrossRef

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34 Huibregtse, K, Katon, RM & Tytgat, GN. Endoscopic treatment of postoperative biliary strictures. Endoscopy 1986; 18 (4): 133–7. PubMed

35 Berkelhammer, C, Kortan, P & Haber, GB. Endoscopic biliary prostheses as treatment for benign postoperative bile duct strictures. Gastrointest Endosc 1989; 35 (2): 95–101. PubMed

36 Davids, PH, Rauws, EA & Coene, PP et al. Endoscopic stenting for post-operative biliary strictures. Gastrointest Endosc 1992; 38 (1): 12–8. PubMed

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38 Weber, J, Adamek, HE & Riemann, JF. Endoscopic stent placement and clip removal for common bile duct stricture after laparoscopic cholecystectomy. Gastrointest Endosc 1992; 38 (2): 181–2. PubMed

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Copyright © Blackwell Publishing, 2004

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Historical background
The changing world of pancreatic–biliary medicine
  The impact of scanning radiology
  Extending the indications for therapeutic ERCP
  Improvements in surgery
  Patient empowerment
  Current focus
Benefits and risks
  Degree of difficulty and expertise
  Report cards
  Unplanned events
  Clinical success and value
The future
  Imaging of the pancreatico-biliary system
   ERCP vs. PTC
Section I: Preparation for ERCP
  Room set-up and floor plan (Figs 1, 2)
   Position of monitors and endoscopy cart (Fig. 2)
  Essential equipment for ERCP
   Side-viewing duodenoscopes
   Forward-viewing scopes
   Sedatives and analgesics
   Smooth muscle relaxants
   Reversal agents
  Monitoring during conscious sedation
  Contrast agents
   Syringes for aspiration and irrigation
  Organization and storage of accessories (Fig. 4)
  Organization of the worktop (Fig. 5)
  Fluoroscopy for ERCP
   Fluoroscopy units (Fig. 6)
   KV and mA
   Split screen
   Magnified view
   Orientation of fluoroscopic images
   Personnel protection (Fig. 8)
   Other protective gear
   Positioning of the patient
  Radiological interpretation
   Scout film (Fig. 7)
   Contrast studies
   Drainage films
   The pancreatogram
   Normal anatomy
   Pathological changes
   Congenital anomalies
   The cholangiogram
   Normal anatomy
   Pathological strictures
   Bile duct stones (Fig. 11)
   Underfilling and delayed drainage
Section II: Diagnostic and therapeutic ERCP
  Diagnostic ERCP
   Accessories (Fig. 13)
   Preparation of patient
   Informed consent
  ERCP procedure
   Intubation and examination of the stomach
   Approaching the main papilla
   Cannulation of the papilla
   Ease and success in cannulation
   Minor papilla cannulation
  Complications of diagnostic ERCP
   Respiratory depression and other complications
  Failed cannulation and special situations
   What to do with a difficult intubation
   Failure to insert the duodenoscope
   Lost in the stomach
   Failure to identify the papilla
   Tip of endoscope is too proximal
   Tip of scope is too distal
   Obscured papilla
   What to do if cannulation is difficult
   Abnormal papilla
   Failed common duct cannulation
   Failed pancreatic duct cannulation
   Failed accessory (minor) papilla cannulation
   Failure to obtain get deep CBD cannulation
   Precut sphincterotomy to assist in CBD cannulation
   Needle-knife precut technique
   Selective cannulation of the intrahepatic system (IHBD)
   Cannulation of the papilla in a Billroth II situation(Fig. 17)
  Therapeutic ERCP
   Standard endoscopic sphincterotomy or papillotomy (Fig. 18)
   Preparation of patients
   Laboratory tests
   The sphincterotome (or papillotome)
   Electrosurgical unit
   Adequacy of sphincterotomy
   Wire-guided sphincterotomes
   Periampullary diverticula and sphincterotomy
   Distorted anatomy
   Precut sphincterotomy for impacted stone
   Indications for sphincterotomy and results
   Complications of sphincterotomy
   Post sphincterotomy bleeding
   What to do if the sphincterotomy fails to cut
   The risk of a half cut
   What to do with a deviated cut
   Sphincterotomy in Billroth II cases
   Stone extraction (Figs 19, 20)
   Endoscopic nasobiliary catheter drainage for bile duct obstruction (Fig. 24)
   Endoscopic plastic stent insertion for malignant biliary obstruction (Fig. 26)
   Preparation of patient
   One-step introducer system
   Bilateral stenting for hilar obstruction
   Brushing cytology for bile duct strictures (Fig. 27)
   Single-lumen system
   Double-lumen system
   Assessment of response to biliary stenting
   Results of biliary stenting
   Complications of stenting
   Early complications
   Late complications
   Self-expandable metal stents
   Stent configurations
   Lengths of stents
   Introducer system for SEMS
   Balloon dilation of biliary strictures (Fig. 28)
   Endoscopic management of bile leaks
Outstanding issues and future trends
  Incidence of CBD stones
  Traditional management
  Non-operative approach to CBD stones
  Classification of CBD stones
   Primary CBD stones
   Bacteriology of primary CBD stones
   Secondary CBD stones
Clinical presentations
  Asymptomatic biliary stones
  Symptomatic biliary stones
   Obstructive jaundice
   Clinical cholangitis
   Biliary pancreatitis
   Oriental cholangitis or recurrent pyogenic cholangitis
  Clinical diagnosis
   Abdominal ultrasound scan
   Endoscopic retrograde cholangiopancreatography (ERCP)
   Magnetic resonance cholangiogram (MRC) for CBD stones
   Endoscopic ultrasonography (EUS) for CBD stones
Management for CBD stones
  ERCP, sphincterotomy, and stone extraction
   Endoscopic sphincterotomy
   Choice of endoscopes
   Cannulation with sphincterotome
   Stone extraction
   Basket stone extraction
   Balloon stone extraction
  Acute pancreatitis
  Sphincterotomy vs. balloon sphincteroplasty
   Balloon sphincteroplasty
   Balloon sphincteroplasty for CBD stones
   Sphincterotomy for CBD stones
   Long-term complications of sphincterotomy
  ERCP vs. laparoscopic common duct exploration for retained CBD stones
   Preoperative ERCP
   Operative removal of CBD stones
   Factors that predict CBD stones
   MRC for detection of CBD stones
   Risk scores for prediction of CBD stones
Alternative approaches to CBD stones
  Precut sphincterotomy for failed deep cannulation
   Complications of precut sphincterotomy
  Percutaneous transhepatic cholangiogram and drainage
   Rendezvous procedure (two-hands technique)
   Percutaneous stone extraction
The challenge: giant CBD stones
  Basket mechanical lithotripsy (BML)
  Through-the-scope BML using a metal sheath
   Results of BML
  Mother and baby choledochoscopy and intraductal lithotripsy
   Electrohydraulic lithotripsy (EHL)
   Intraductal laser lithotripsy
  Stenting and interval endoscopic lithotripsy
   Effects of stenting on CBD stones
   The need for stone extraction after stenting
  Extracorporeal shock-wave lithotripsy (ESWL)
   Results of ESWL for CBD stones
  Open surgery
Intrahepatic duct stones
  ERCP and basket removal
  Wire-guided basket
  Percutaneous transhepatic cholangioscopy (PTC)
   Results of percutaneous treatment of intrahepatic stones
ERCP and sphincterotomy in Billroth II gastrectomy
  Precaution and alternatives for Billroth II gastrectomy
  Side-viewing vs. forward-viewing scope for ERCP in Billroth II gastrectomy
   Effect of biliary obstruction on the reticuloendothelial system
   Bacteriology of cholangitis
   Effect of raised intrabiliary pressure and cholangiovenous reflux
  Clinical presentation
   Simple cholangitis: Charcot's triad
   Suppurative cholangitis: Reynold's pentad
  Clinical management
   Initial conservative management
   Urgent biliary decompression
   Role of ERCP
   Endoscopic drainage vs. surgery
   ERCP vs. PTBD
   Nasobiliary catheter drainage vs. stenting in acute cholangitis
   Surgery to prevent recurrent cholangitis
   Types of operation
Outstanding issues and future trends
ERCP in diagnosis of pancreatico-biliary malignancies
  Radiological diagnosis
   Significance of 'double duct stricture' sign
  Tissue diagnosis
   Brush cytology, biopsy, and FNA
  Tumor markers in bile or pancreatic juice
Direct endoscopic examination of pancreatico-biliary malignancies
Intraductal ultrasound [IDUS]
Magnetic resonance cholangiopancreatography
Palliation of inoperable pancreatico-biliary malignancies
  Endoscopic stenting for malignant jaundice
   Technique of endoscopic stent insertion
   Types of stents
   Plastic stents
   Metal stents
   Metal vs. plastic stents
   Covered and uncovered metal stents
   Biodegradable stents
   Endoscopic stenting for hilar strictures
   Bismuth classification for hilar obstruction
   Unilateral vs bilateral drainage for hilar obstruction
  Other techniques of endoscopic palliation
   Intraductal photodynamic therapy
ERCP in management of ampullary neoplasms
  Benign tumors
   Ampullary carcinoma
Outstanding issues and future trends
Classification of bile duct injuries
Diagnostic protocol
Management of bile duct leakage after cholecystectomy
  Type A injury (peripheral leaks)
  Type B injury (main duct leaks)
  Type C injuries (postoperative biliary strictures)
  Type D injury (transections)
   Delayed reconstruction
Surgical treatment of postoperative biliary strictures
Percutaneous treatment of postoperative strictures
Endoscopic treatment of postoperative biliary strictures
  Reported results
  Phases of endoscopic treatment
   Stent insertion phase
   Stenting phase
   Follow-up phase
Postoperative biliary strictures: surgery or endoscopy [43]?
  Recurrent strictures after surgery
Metal stents for benign strictures
A more aggressive treatment protocol?
Outstanding issues and future trends
  Sphincter of Oddi dysfunction
  Sphincter of Oddi stenosis
Classification of SOD
  SOD in patients with gallbladder disease
  SOD after cholecystectomy
  SOD in the biliary or pancreatic sphincter, or both
  SOD and pancreatitis
Clinical presentation
  The Rome criteria
Initial evaluation
  Serum chemistries
  Standard imaging
Non-invasive diagnostic methods for SOD
  Morphine–prostigmin provocative test (Nardi test)
  Radiographic assessment of extrahepatic bile duct and main pancreatic duct diameter after secretory stimulation
   Ultrasound provocation testing
   Endoscopic ultrasound monitoring
   MRCP monitoring
  Quantitative hepatobiliary scintigraphy
   Adding morphine provocation
  Comparing non-invasive tests
  Current status of non-invasive methods
Invasive diagnostic methods for SOD
  Intraductal ultrasonography (IDUS)
Sphincter of Oddi manometry
  Sphincter of Oddi manometry: technique and indications
   Drug interactions
   Manometry catheters
   Cannulation techniques
   Study both sphincters
  Interpretation of manometry traces
   Normal values
  Complications of SOM
   Methods to reduce complications
   Aspirating catheter system
   Prophylactic stenting
  Sphincter of Oddi manometry; conclusion
   Type I patients
   Type II patients
   Type III patients
Therapy for sphincter of Oddi dysfunction
  Medical therapy
   Electrical nerve stimulation
  Surgical therapy
  Endoscopic balloon dilation and biliary stent trials
  Endoscopic sphincterotomy
   Randomized controlled trials of endoscopic sphincterotomy for SOD
   Is pancreatic sphincterotomy necessary?
  Risks and benefits of endoscopic treatment for SOD
  Botulinum toxin injection
Sphincter of Oddi dysfunction in recurrent pancreatitis
  Endoscopic sphincterotomy for SOD in pancreatitis
   Lans and colleagues
   Guelrud and colleagues
   Kaw and Brodmerkel
   Toouli and colleagues
   Okolo and colleagues
  Endoscopic sphincterotomy as a cause of pancreatic sphincter stenosis
  Endoscopic Botox injection
  SOD in recurrent pancreatitis: conclusion
Outstanding issues and future trends
Interdisciplinary management; complex ERCP
Acute gallstone pancreatitis
  Clinical diagnosis of acute gallstone pancreatitis
  Predicting severity of acute pancreatitis
  Acute treatment
  The role of early ERCP
   British study
   Hong Kong study
   Polish study
   German study
   Meta-analysis of studies of early ERCP, and current consensus
   ERCP is rarely indicated before cholecystectomy in patients with gallstone pancreatitis
   Acute pancreatitis postcholecystectomy
   Treatment by biliary sphincterotomy alone?
Pancreatic duct disruptions
  Stenting for duct disruption
Smoldering pancreatitis
Acute recurrent pancreatitis
  'Idiopathic' pancreatitis
  Microlithiasis and occult gallstones
   Detecting microlithiasis
   Bile crystals
   Empiric cholecystectomy?
  Sphincter of Oddi dysfunction (SOD)
   Diagnosis of SOD
   Endoscopic therapy for SOD
   Sphincterotomy without sphincter manometry?
   Is sphincter manometry dangerous?
   SOD in patients with intact gallbladders
  Pancreas divisum
   Does pancreas divisum cause pancreatitis?
   Endoscopic treatment for pancreas divisum
   Stenting for pancreas divisum
   Problems with endoscopic therapy
  Chronic pancreatitis (idiopathic, alcohol, familial, other)
   Endoscopic therapy for chronic pancreatitis
  Pancreatitis due to neoplastic obstruction
   Endoscopic management of neoplastic obstruction
   Stenting for smoldering pancreatitis due to malignancy
  Other rare causes of pancreatitis
Overall approach to unexplained acute pancreatitis
  Concerns about ERCP and empiric sphincterotomy in recurrent acute pancreatitis
   Risks of ERCP
  Investigations other than ERCP
  Recommended approach to ERCP for acute recurrent pancreatitis
  Final diagnosis in recurrent acute pancreatitis after extensive investigation
   Our experience
   Occult neoplasms
   Endoscopic treatment and results
Outstanding issues and future trends
Chronic pancreatitis
Treatments for chronic pancreatitis
  Medical therapy
  Surgical therapy
  Endoscopic treatment for chronic pancreatitis
   Safety issues
   Indications for endoscopic treatment
   Results of endoscopic treatment
Pancreatic ductal strictures
  Pancreatic stent placement techniques
  Efficacy of pancreatic duct stenting
   Cremer and colleagues
   Ponchon and colleagues
   Smits and colleagues
   Ashby and Lo
   Hereditary and early onset pancreatitis
   Predicting the outcome
  Duration of stenting
  Does response to stenting predict the outcome of surgery?
  Long-term follow-up
  Complications associated with pancreatic stents
   Stent-induced duct changes
   Brief mini-stents
Pancreatic ductal stones
  Causes of pancreatic ductal stones
  Stones cause obstruction
  Endoscopic techniques for stone extraction
   Pancreatic sphincterotomy
   Biliary sphincterotomy also?
   Pancreas divisum
   Stone removal
   Results of endoscopic treatment for stones
   Sherman and colleagues
   Smits and colleagues
   Cremer and colleagues
   Summary results
   Endoscopic therapy with ESWL
   Sauerbruch and colleagues
   The Brussels group
   Kozarek and colleagues
   Farbacher and colleagues
   Intraductal lithotripsy
   Medical treatment for stones
   Overall results for stone treatment
Pancreatic pseudocysts
  Endoscopic treatment for pseudocysts
Biliary obstruction in chronic pancreatitis
  Standard biliary stents
   Deviere and colleagues
   The Amsterdam group
   Barthet and colleagues
  Metal stents for biliary obstruction?
  Biodegradable stents
  Stenting for biliary strictures and chronic pancreatitis: conclusion
Sphincter of Oddi dysfunction in chronic pancreatitis
  Pathogenesis of SOD in chronic pancreatitis
  Frequency of SOD in chronic pancreatitis
  Surgical sphincter ablation
  Endoscopic pancreatic sphincterotomy
Pancreas divisum
  Pancreas divisum: a cause of pancreatitis?
  Minor papilla ablation
Outstanding issues and future trends
Toxic and metabolic complications
Pancreatic fluid collections
Pseudocysts and abscesses
Pancreatic necrosis
  Organizing necrosis
Miscellaneous complications
  Pancreatic fistulas
  Ductal disruption
  Vascular complications
   Venous thrombosis
Arterial complications
Outstanding issues and future trends
Patient preparation
  Sedation for ERCP in children
  Antibiotic prophylaxis
  Other medication
  Biliary indications
  Pancreatic indications
Success rates for ERCP in children
Biliary findings (Fig. 3)
  Biliary atresia vs. neonatal hepatitis
   ERCP findings
  Miscellaneous genetic cholestatic diseases
  Bile plug syndrome
  Choledochal cyst
   Pathogenesis of choledochal cyst
   Classification of anomalous ductal union
   Classification of choledochal cysts
   Type I
   Type II
   Type III
   Type IV
   Type V
   Treatment of choledochal cysts
   Fusiform choledochal dilatation and carcinoma
  Primary sclerosing cholangitis
  Parasitic infestation
   ERCP for stones
  Biliary strictures and leaks
   Primary stricture
   Malignant strictures
   Liver transplantation
   Bile leaks
Pancreatic findings (Fig. 17)
  Recurrent pancreatitis
   Choledochal cyst and anomalous pancreatico-biliary union
   Pancreas divisum
   Prevalence of pancreas divisum
   Significance of pancreas divisum
   ERCP diagnosis of pancreas divisum
   Treatment of pancreas divisum
   Other pancreatic congenital anomalies
   Duodenal duplication cyst
   Sphincter of Oddi dysfunction
   Pancreatic trauma
   Acquired immunodeficiency syndrome
  Chronic pancreatitis
   Endoscopic treatment of chronic pancreatitis in children
  Pancreatic pseudocysts
Outstanding issues and future trends
The risks of ERCP
  Risks for endoscopists and staff
  Technical failure
   Degree of difficulty scale for ERCP procedures (Fig. 1)
   Level 1
   Level 2
   Level 3
   Defining intent
   Risk consequences of technical failure
  Clinical failure
Unplanned adverse clinical events—complications
  When does an event become a complication?
   Complication definition
   Severity criteria
  Types of adverse clinical events
  Timing of events and attribution
  A dataset for unplanned events
Overall complication rates
  Accuracy of data collection
  Changes in complications over time
  Complication rates at MUSC
General risk issues
  Operator-related issues
  Patient-related issues; clinical status, indications, and comorbidities
   Illness and associated conditions
   Anatomical factors
   Complication-specific risk factors
  Procedure performed
   Diagnostic or therapeutic?
   Biliary sphincterotomy
   Pancreatic sphincterotomy
   Precut sphincterotomy
   Repeat sphincterotomy
   Balloon sphincter dilation
   Endoscopic papillectomy
   Pseudocyst drainage
Reducing the risks of ERCP: general issues
  The contract with the patient; informed consent
   Educational materials
  Care after ERCP
   Early refeeding?
Pancreatitis after ERCP
  Incidence of pancreatitis after ERCP
  Risk factors for pancreatitis
   Patient factors increasing the risk [114,115,122,123]
   Procedure factors increasing the risk
   Pancreatic manipulation
   Sphincter manometry
   Biliary sphincter dilation
   Biliary stenting
   Pancreatic stenting
   Combining patient- and procedure-related factors
  Prevention of pancreatitis after ERCP
   Avoiding ERCP, especially in high-risk patients
   Mechanical factors
   Contrast agents
   Pharmacological prophylaxis
   Pancreatic stenting to prevent pancreatitis
   Feeding and monitoring
  Post-ERCP pancreatitis, recognition, and management
  Post-ERCP pancreatitis, conclusion
  Duct and tumor 'penetrations'
  Sphincterotomy-related perforation
   Risk factors for sphincterotomy perforation
   Recognition of sphincterotomy perforation
   Reducing risks of sphincterotomy perforation
   Management of sphincterotomy perforation
  Perforation remote from the papilla
   Recognition and management of endoscopic perforation
  Stent migration perforation
Infection after ERCP
  Nosocomial infection
  Pancreatic sepsis
  Prophylactic antibiotics
  Delayed infection
Bleeding after ERCP
  Definition of bleeding, and incidence
  Risk factors for bleeding, and avoidance
  Management of sphincterotomy bleeding
   Delayed bleeding
Complications of stents
  Blockage of (plastic) biliary stents
  Stent migration
  Duct damage due to stents
Basket impaction
Cardiopulmonary complications and sedation issues
Rare complications
Deaths after ERCP
Late complications
  Diagnostic error
  Late infection
  Late effects of sphincterotomy
  Sphincterotomy with the gallbladder in place
  Pancreatic sphincterotomy
Managing adverse events
  Prompt recognition and action
  Professionalism and communication
Learning from lawsuits
  Financial concerns
  Standard of care practice
   The procedure
   Postprocedure care
Outstanding issues and future trends

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