Pancreatic stent to prevent pancreatitis after transpapillary gallbladder-preserving stone removal for patients with gallbladder and common bile duct stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial assigns adults with gallbladder stones and concomitant common bile duct stones to receive either rectal indomethacin alone or rectal indomethacin plus a prophylactic pancreatic duct stent during endoscopic transpapillary gallbladder-preserving cholecystolithotomy (ERCP-GPC). Clinical data and patient-reported outcomes are collected at baseline and during scheduled follow-up visits to capture the incidence of post-ERCP pancreatitis and other postoperative complications. The study compares efficacy between the two arms and includes economic analyses to evaluate cost differences related to stent placement. Subgroup analyses are planned to identify which patients derive the greatest benefit from prophylactic stent implantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 18 years or older;
2. Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI);
3. Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
4. Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP;
5. The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
6. 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 ;
7. Patients who voluntarily provide signed informed consent.

Exclusion Criteria:

1. Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome;
2. Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations;
3. Patients unfit for ERCP endoscopic treatment due to severe systemic diseases;
4. Patients with severe coagulation dysfunction (defined as an International Normalized Ratio \[INR\] \>1.5) or significant thrombocytopenia (platelet count \<50×10⁹/L);
5. Pregnant women;
6. Patients with guidewire entry into the pancreatic duct ≥3 times during the procedure;
7. Patients with allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs);
8. Patients with congenital or acquired absence of the rectum;
9. Patients with severe acute pancreatitis

Where it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Tao Yu, MD — Qilu Hospital of Shandong University
• Study coordinator: Zhen Li, MD
• Email: qilulizhen@sdu.edu.cn
• Phone: 18560086106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.