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

NCT07495111 | Recruiting

• 1 other identifier: 2025SDU-QILU-2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholelithiasis Associated With Common Bile Duct Stones

Keywords

Cholelithiasis with Concomitant Choledocholithiasis; Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy; post-ERCP pancreatitis; Randomized Controlled Trial (RCT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis

  Within 1 months after ERCP

• Clinical Success Rate

  Within 1 months after ERCP

• The Proportion of Patients with Other Complications

  Within 6 months after ERCP

Study Arms (2)

Receive rectal indomethacin alone

OTHER

Drug: rectal indomethacin alone

Combination of indomethacin plus a prophylactic pancreatic stent

EXPERIMENTAL

Device: Prophylactic pancreatic stent

Interventions

Prophylactic pancreatic stent DEVICE

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.

Combination of indomethacin plus a prophylactic pancreatic stent

rectal indomethacin alone DRUG

rectal indomethacin was used alone in the control group

Receive rectal indomethacin alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• Patients who voluntarily provide signed informed consent.

You may not qualify if:

• 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;
• Patients with severe acute pancreatitis

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• 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
• Qingdao Municipal Hospital: collaborator
• Shengli Oilfield Hospital: collaborator
• Qilu Hospital of Shandong University (Qingdao): collaborator
• The Second Hospital of Shandong University: collaborator
• Dezhou Hospital Qilu Hospital of Shandong University: collaborator
• Central Hospital of Zibo: collaborator
• Qianfoshan Hospital: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

RECRUITING

Study Officials

• Tao Yu, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Li, MD

CONTACT

18560086106; qilulizhen@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: March 27, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)