BridgeMD
New treatment option for Cholelithiasis Associated With Common Bile Duct Stones
Official title Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
ClinicalTrials.gov ID: NCT07495111
What this study is testing
What is rectal indomethacin alone?
rectal indomethacin alone is an investigational medicine, being studied as a potential treatment for cholelithiasis associated with common bile duct stones.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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;
You likely can't join if
- Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi...
- 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...
- Pregnant women;
- Patients with guidewire entry into the pancreatic duct ≥3 times during the procedure;
See the full eligibility 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...
- Patients who voluntarily provide signed informed consent.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.