Actively Recruiting
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
Led by Qilu Hospital of Shandong University · Updated on 2026-03-27
88
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
Q
Qilu Hospital of Shandong University
Lead Sponsor
T
The Affiliated Hospital of Qingdao University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Patients with gallbladder stones and common bile duct stones confirmed by ultrasound, MRCP, CT, or MRI
- Gallbladder stones 1 cm or smaller in diameter or sludge-like stones
- No history of gastrointestinal reconstruction surgery, cholecystectomy, biliary surgery, or previous ERCP
- Normal gallbladder shape and size with gallbladder wall thickness 3 mm or less
- Presence of at least one high-risk factor for post-ERCP pancreatitis, such as suspected sphincter of Oddi dysfunction, female sex, history of pancreatitis, difficult cannulation, pancreatic duct contrast injection, age under 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
- Voluntary signed informed consent
You will not qualify if you...
- Diagnosis of chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder cancer, or Mirizzi syndrome
- Ectopic duodenal papilla or congenital pancreaticobiliary malformations
- Unfit for ERCP due to severe systemic diseases
- Severe coagulation problems (INR over 1.5) or low platelet count (below 50×10⁹/L)
- Pregnancy
- Guidewire entry into pancreatic duct three or more times during procedure
- Allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
- Congenital or acquired absence of the rectum
- Severe acute pancreatitis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250063
Actively Recruiting
Research Team
Z
Zhen Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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