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.
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;
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);
Parallel
Prophylactic pancreatic stent
DeviceAll procedure-related interventions except for the administration of rectal indomethacin and placement of a prophylactic stent were left to the discretion of the endoscopist.During ERCP, once eligibility was confirmed, patients were randomized in a 1:1 ratio to receive a prophylactic stent or not.In patients assigned to the indomethacin plus stent group, endoscopists were expected to attempt stent placement, although the technical approach, including the amount of time and effort expended for this purpose, was not standardized.All patients received 100mg indomethacin suppositories.
rectal indomethacin alone
Drugrectal indomethacin was used alone in the control group
The Proportion of Patients with Post-ERCP Pancreatitis
If a patient exhibits two out of the following three characteristics, a diagnosis of postoperative pancreatitis is made: (1) Abdominal pain consistent with acute pancreatitis, (2) Serum amylase and/or lipase levels at least three times the upper limit of normal, and (3) Abdominal imaging studies showing radiological changes consistent with acute pancreatitis.
The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis
The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of \> 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention.
Clinical Success Rate
Complete removal of gallbladder stones.
The Proportion of Patients with Other Complications
Other complications mainly include bleeding, cholangitis, cholecystitis, perforation, hypoxemia, hypotension or hypertension, etc.
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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
