Safety and effectiveness of modified laparoscopic transcystic biliary drainage in the treatment of choledocholithiasis: study protocol for a prospective single-arm clinical trial.

introductionSeveral techniques are used for laparoscopic treatment of gallstone disease with biliary duct stone, but each approach has indications and shortcomings. We have developed a modified laparoscopic transcystic biliary drainage for the management of cholecysto-choledocholithiasis. The hypothesis is that the modified laparoscopic transcystic biliary drainage will reduce morbidity from around 15% to less than 5%. The aim of this study is to assess the safety and efficacy of the modified laparoscopic transcystic biliary drainage. METHODS AND ANALYSIS: This is a prospective single-arm clinical trial to evaluate the safety and efficacy of the modified laparoscopic transcystic biliary drainage. The recruited 310 patients will be from Peking University Third Hospital. (Here, patients who meet the inclusion criteria will be included in the study, all patients will undergo laparoscopic cholecystectomy with concomitant laparoscopic exploration of the common bile duct and a modified laparoscopic transcystic drainage.) The primary endpoint is the postoperative morbidity and bile leakage. The secondary endpoints of the study are anchoring time of the C-tube, average daily drainage volume, early dislodgement of the C-tube, removal time of the C-tube, pancreatitis, residual stones and postoperative hospital stay. Recurrent stones and biliary stricture will be recorded during 6 months of follow-up. A two-tailed p<0.05 was considered statistically significant. SPSS for Windows V.21.0 (SPSS) software was used. ETHICS AND DISSEMINATION: This clinical trial was approved by the Medical Science Research Ethics Committee of Peking University Third Hospital (No. M2023223). TRIAL REGISTRATION NUMBER: NCT06011941. PROTOCOL VERSION: V.2, 23 November 2023.