Researchers from the Netherlands assessed whether a wait-and-see policy is justified in patients who undergo endoscopic sphincterotomy for common bile duct stones, and who have residual gallbladder stones.
These patients are normally referred for laparoscopic cholecystectomy. However, only 10% of patients who do not have this operation are reported to develop recurrent biliary symptoms.
A total of 120 patients (age 18-80 years), who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones, were included in the multicenter trial.
Patients were randomly allocated to wait and see (n = 64) or laparoscopic cholecystectomy (n = 56).
The team evaluated reoccurrence of at least 1 biliary event during 2-year follow-up.
The secondary outcomes measured were complications of cholecystectomy and quality of life.
Some 12 patients were lost to follow-up immediately.
|47% of patients allocated to wait-and-see policy developed at least 1 recurrent biliary event.
Of 59 patients allocated to wait and see, 27 (47%) had recurrent biliary symptoms, compared with 1 (2%) of 49 patients after laparoscopic cholecystectomy (relative risk 22·4).
Of the 27 patients allocated to wait and see, with recurrent problems, 81% underwent cholecystectomy. This was mainly for biliary pain (n = 13) or acute cholecystitis (n = 7).
Conversion rate to open surgery was 55% in patients allocated to wait and see, who underwent cholecystectomy.
Among those allocated to laparoscopic cholecystectomy, the conversion rate was 23%.
The authors discovered that morbidity was 32% versus 14%, and median hospital stay was 9 versus 7 days, respectively.
Quality of life was found to return to normal within 3 months after either treatment policy.
Dr Djemila Boerma, of the Academic Medical Center, Amsterdam, said on behalf of the group, "A wait-and-see policy after endoscopic sphincterotomy in combined cholecystodocholithiasis cannot be recommended as standard treatment.
"This is because 47% of expectantly managed patients developed at least 1 recurrent biliary event and 37% needed cholecystectomy."
"No major biliary complications arose, but conversion rate was high," it was concluded.