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Clinical Trial NCT07495111 for Cholelithiasis Associated With Common Bile Duct Stones is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis 88 Randomized

Recruiting
Clinical Trial NCT07495111 is an interventional study for Cholelithiasis Associated With Common Bile Duct Stones that is recruiting. It started on December 1, 2025 with plans to enroll 88 participants. Led by Qilu Hospital of Shandong University, it is expected to complete by June 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
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 colle...Show More
Official Title

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

Conditions
Cholelithiasis Associated With Common Bile Duct Stones
Other Study IDs
  • 2025SDU-QILU-2
NCT ID Number
NCT07495111
Start Date (Actual)
2025-12-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2028-06
Enrollment (Estimated)
88
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Cholelithiasis with Concomitant Choledocholithiasis
Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy
post-ERCP pancreatitis
Randomized Controlled Trial (RCT)
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherReceive rectal indomethacin alone
rectal indomethacin alone
rectal indomethacin was used alone in the control group
ExperimentalCombination of indomethacin plus a prophylactic pancreatic stent
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...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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
Qilu Hospital of Shandong University logoQilu Hospital of Shandong University
Study Central Contact
Contact: Zhen Li, MD, 18560086106, [email protected]
1 Study Locations in 1 Countries

Shandong

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