Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Choleli… (NCT07495111) | Clinical Trial Compass
RecruitingNot Applicable
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
China88 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
. Patients with at least one of the following high-risk factors for post-ERCP pancreatitis (PEP): suspected sphincter of Oddi dysfunction (SOD), female sex, history of pancreatitis, difficult cannulation (defined as ≥5 cannulation attempts or ≥5 minutes of cannulation time), pancreatic duct contrast injection, age \<35 years, non-dilated extrahepatic bile duct, no history of chronic pancreatitis, normal serum bilirubin, precut sphincterotomy, biliary balloon dilation, incomplete bile duct stone clearance, or intraductal ultrasound ;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Proportion of Patients with Post-ERCP Pancreatitis
. Patients who voluntarily provide signed informed consent.
Exclusion criteria
. 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);
. Pregnant women;
. Patients with guidewire entry into the pancreatic duct ≥3 times during the procedure;
. Patients with allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs);
. Patients with congenital or acquired absence of the rectum;