Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis

In this multicenter, randomized trial, patients with cholelithiasis with concomitant choledocholithiasis based on inclusion and exclusion criteria will be randomly assigned to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent after endoscopic transpapillary gallbladder-preserving cholecystolithotomy.Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. The study aims to analyze the impact of pancreatic duct stent implantation on the incidence of post-ERCP pancreatitis in gallstone patients treated with ERCP-GPC by comparing the efficacy differences between the experimental and control groups. Additionally, the study investigate the effects of pancreatic duct stent placement post-ERCP on other postoperative complications, conduct a comparative analysis of the economic benefits of placing versus not placing pancreatic duct stents after ERCP, and develop effective clinical strategies for preventing pancreatitis after gallbladder-preserving stone extraction in gallstone patients.

NCT Number	NCT07495111
Lead Sponsor	Qilu Hospital of Shandong University Collaborators: The Affiliated Hospital of Qingdao University, Linyi People's Hospital, Rizhao People's Hospital, Taian City Central Hospital, Shandong Province Third hospital, Binzhou Medical University, Liaocheng People's Hospital, Weifang People's Hospital, Central Hospital of Zibo, Qianfoshan Hospital, Qilu Hospital of Shandong University (Qingdao), Qingdao Municipal Hospital, Shengli Oilfield Hospital, The Second Hospital of Shandong University, Dezhou Hospital Qilu Hospital of Shandong University
Conditions	Cholelithiasis Associated With Common Bile Duct Stones
Enrollment	88 participants
Start Date	2025-12-01
Primary Completion	2028-06 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-05-18