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Recruiting NCT07495111

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

No phase Interventional Cholelithiasis Associated With Common Bile Duct Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prophylactic pancreatic stent, rectal indomethacin alone.
Who it may be relevant to
Registry conditions: Cholelithiasis Associated With Common Bile Duct Stones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 th
  • Drug rectal indomethacin alone
    rectal indomethacin was used alone in the control group

Primary outcome measures

  • The Proportion of Patients with Post-ERCP Pancreatitis [Time frame: 24 hours to 72 hours after ERCP]
Secondary outcome measures (3)
  • The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis [Time frame: Within 1 months after ERCP]
  • Clinical Success Rate [Time frame: Within 1 months after ERCP]
  • The Proportion of Patients with Other Complications [Time frame: Within 6 months after ERCP]

Eligibility criteria

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 ;
  • 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;
  • Patients with severe acute pancreatitis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT07495111 · 2025SDU-QILU-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗