Dr Leslie Nathanson and colleagues prospectively evaluated the limitations of laparoscopic choledochotomy or postoperative endoscopic retrograde cholangiography (ERCP), for patients failing laparoscopic trans-cystic clearance.
The researchers also assessed whether these patients should have laparoscopic choledochotomy or postoperative ERCP.
Clinical management of bile duct stones found at laparoscopic cholecystectomy in the last decade has focused on pre-cholecystectomy detection with ERCP clearance in those with suspected stones.
This clinical algorithm successfully clears the stones in most patients, but no stones are found in 20% to 60% of patients.
Rare unpredictably severe ERCP morbidity can result in this group.
The researchers' reported of their initial experience with 300 consecutive patients with fluoroscopic cholangiography and intraoperative clearance.
The team demonstrated that, for the pattern of stone disease seen, 66% of patients' bile duct stones can be cleared via the cystic duct with reduction in morbidity vs 33% requiring choledochotomy or ERCP.
The team intraoperatively randomized patients across 7 metropolitan hospitals after failed trans-cystic duct clearance to either laparoscopic choledochotomy or postoperative ERCP.
The exclusion criteria included ERCP prior to referral for cholecystectomy, and severe cholangitis or pancreatitis requiring immediate ERCP drainage.
Other exclusion criteria were common bile ducts with a diameter of less than 7 mm, or if bilio-enteric drainage was required in addition to stone clearance.
|Total operative time was 11 minutes longer in the choledochotomy group, with slightly shorter hospital stay |
|Annals of Surgery|
The team used drain decompression of the cleared bile ducts in the presence of cholangitis.
An edematous ampulla was used by the researchers due to instrumentation or stone impaction and technical difficulties from local inflammation and fibrosis.
The ERCP occurred prior to discharge from hospital, and mechanical or extracorporeal shockwave lithotripsy was available.
The team reported that sphincter balloon dilation as an alternative to sphincterotomy to allow stone extraction was not used.
Major endpoints for the trial were operative time, morbidity, retained stone rate, reoperation rate, and hospital stay.
The team noted that from 1998 to 2003, 372 patients with bile duct stones had successful trans-cystic duct clearance of stones in 286, leaving 86 patients randomized into the trial.
The researchers found that total operative time was 11 minutes longer in the choledochotomy group, with slightly shorter hospital stay of 6 days versus 8 days.
Bile leak occurred in 15% of those having choledochotomy with similar rates of pancreatitis between the groups of 7% vs 9%.
Other results that were similar between the groups included retained stones at 2% vs 4%, reoperation both at 7%, and overall morbidity of 17% vs 13%.
Dr Nathanson concludes, “These data suggest that the majority of secondary bile duct stones can be diagnosed at the time of cholecystectomy and cleared trans-cystically, with those failing having either choledochotomy or postoperative ERCP.”
“However, because of the small trial size, a significant chance exists that small differences in outcome may exist.”
“We would avoid choledochotomy in ducts less than 7 mm measured at the time of operative cholangiogram and severely inflamed friable tissues leading to a difficult dissection.”
“We would advocate choledochotomy as a good choice for patients after Billroth 11 gastrectomy, failed ERCP access, or where long delays would occur for patient transfer to other locations for the ERCP.”