Randomized controlled trial of primary closure after common bile duct exploration with self-detachable biliary stent placement versus direct primary closure: A new alternative to reduce bile leakage risk.

Abstract

Bile leakage is the most common complication after laparoscopic common bile duct exploration. This study explores the clinical efficacy of using a 5-F biliary stent with automatic detachment to prevent bile leakage postbiliary exploration. This randomized controlled observational study was conducted from January 2023 to January 2025. Patients undergoing primary closure of the common bile duct in our team were randomly divided into 2 groups. The treatment group had biliary stents placed during biliary stone extraction and then primary closure, whereas the control group had direct primary closure after stone extraction. The primary outcome was bile leakage incidence. The secondary outcome measure was the rate of automatic removal of biliary stents, surgical time, postoperative hospital stay, postoperative blood test indicators, and complications. Both groups included 85 patients. Preoperative data such as white blood cell count, aspartate transaminase, alanine aminotransferase, total bilirubin, direct bilirubin, albumin, serum amylase, serum lipase, common bile duct diameter, and stone characteristics were comparable (P > .05). In the treatment group, stent placement took 8 (5-12) minutes. All stents were in place at 72 hours post operatively. The automatic detachment rate at 1 month was 98.93%, with 1 case removed via duodenoscopy. The bile leakage rate (1.17% vs 9.41%), surgical time (103.11 ± 10.16 minutes vs 99.89 ± 9.07 minutes), and postoperative hospital stay (4.56 ± 0.69 days vs 5.09 ± 0.84 days) were significantly different between the groups (P < .05). There were no significant differences in postoperative 48-hour blood indicators (P > .05), but total bilirubin, direct bilirubin, and alanine aminotransferase decreased significantly compared with preoperative levels in both groups. Placing a 5-F biliary stent with automatic detachment during laparoscopic common bile duct exploration for stone extraction and then performing primary closure can effectively reduce bile leakage and postoperative hospital stay. With a short placement time and high automatic detachment rate, this method is simple and worthy of promotion.