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

Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis After Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy for Cholelithiasis With Concomitant Choledocholithiasis

This trial will test whether adding a preventive pancreatic stent to standard rectal indomethacin lowers the risk of pancreatitis after transpapillary gallbladder-preserving stone removal in adults with gallbladder stones and common bile duct stones.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07495111 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with gallbladder stones ≤1 cm or sludge and confirmed common bile duct stones, normal gallbladder morphology, no prior biliary surgery, and at least one high-risk factor for post-ERCP pancreatitis are ideal candidates.

Not a fit: Patients with larger gallbladder stones (>1 cm), prior biliary or gastric surgery, altered anatomy, chronic pancreatitis, or those not undergoing ERCP-GPC are unlikely to gain benefit from this intervention.

Why it matters

Potential benefit: If successful, adding a prophylactic pancreatic stent could reduce post-ERCP pancreatitis, lower complication-related costs, and speed recovery for affected patients.

How similar studies have performed: Previous randomized trials and meta-analyses have shown that rectal indomethacin and prophylactic pancreatic stents each reduce post-ERCP pancreatitis in high-risk patients, though combining both approaches has been less extensively studied.

Eligibility criteria

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 this trial is running

Jinan, Shandong

• 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

Conditions Cholelithiasis Associated With Common Bile Duct Stones; Cholelithiasis with Concomitant Choledocholithiasis; Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy; post-ERCP pancreatitis; Randomized Controlled Trial