About this trial
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.
Eligibility criteria
Qualifiers
Patients aged 18 years or older;
Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI);
Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP;
Disqualifiers
Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome;
Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations;
Patients unfit for ERCP endoscopic treatment due to severe systemic diseases;
Patients with severe coagulation dysfunction (defined as an International Normalized Ratio [INR] >1.5) or significant thrombocytopenia (platelet count <50×10⁹/L);
Trial design
Treatments tested in this trial
- Prophylactic pancreatic stent
- rectal indomethacin alone
Treatment groups
Sponsors and collaborators
Qilu Hospital of Shandong University
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborator
Linyi People's Hospital
Collaborator
Rizhao People's Hospital
Collaborator
Taian City Central Hospital
Collaborator
Shandong Province Third hospital
Collaborator
Binzhou Medical University
Collaborator
Liaocheng People's Hospital
Collaborator
Weifang People's Hospital
Collaborator
Central Hospital of Zibo
Collaborator
Qianfoshan Hospital
Collaborator
Qilu Hospital of Shandong University (Qingdao)
Collaborator
Qingdao Municipal Hospital
Collaborator
Shengli Oilfield Hospital
Collaborator
The Second Hospital of Shandong University
Collaborator
Dezhou Hospital Qilu Hospital of Shandong University
Collaborator