Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cholelithiasis Associated With Common Bile Duct Stones
• Intervention / Treatment: Drug: rectal indomethacin alone; Device: Prophylactic pancreatic stent

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen Li, MD; Phone Number: 18560086106; Email: qilulizhen@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250063
      • Recruiting
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Receive rectal indomethacin alone	Drug: rectal indomethacin alone; rectal indomethacin was used alone in the control group
Experimental: Combination of indomethacin plus a prophylactic pancreatic stent	Device: Prophylactic pancreatic stent; All 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours to 72 hours after ERCP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 1 months after ERCP
Clinical Success Rate	Complete removal of gallbladder stones.	Within 1 months after ERCP
The Proportion of Patients with Other Complications	Other complications mainly include bleeding, cholangitis, cholecystitis, perforation, hypoxemia, hypotension or hypertension, etc.	Within 6 months after ERCP

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: The Affiliated Hospital of Qingdao University; Qingdao Municipal Hospital; Qianfoshan Hospital; The Second Hospital of Shandong University; Liaocheng People's Hospital; Linyi People's Hospital; Taian City Central Hospital; Weifang People's Hospital; Shengli Oilfield Hospital; Qilu Hospital of Shandong University (Qingdao); Binzhou Medical University; Rizhao People's Hospital; Shandong Province Third hospital; Central Hospital of Zibo; Dezhou Hospital Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Tao Yu, MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial (RCT); post-ERCP pancreatitis; Cholelithiasis with Concomitant Choledocholithiasis; Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy
• Other Study ID Numbers: 2025SDU-QILU-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No