A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates
| Registry | NCT07222527 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Mayo Clinic (Other) |
| Conditions | Recurrent Cholecystitis, Cholecystitis, Symptomatic Gallbladder Disease, Biliary Colic |
| Interventions | ERCP with one stent placement, ERCP with two stent placement (Procedure) |
| Dates | start 2025-12-12, primary completion 2027-05-27 (estimated), completion 2028-05-27 (estimated), first posted 2025-10-30, last updated 2025-12-16 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Recurrent Cholecystitis All trials for Cholecystitis All trials of ERCP with one stent placement All trials of ERCP with two stent placement
This randomized trial will look at whether placing two cystic duct stents is more effective than one cystic duct stent in preventing recurrent gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) among patients who are not immediate surgical candidates for removal of their gallbladder.
The study will evaluate the safety profile, including rates of recurrent cholecystitis, biliary colic, and procedure-related complications, and technical success, defined as successful placement of stents into the gallbladder.
The main questions it aims to answer are:
1. Does placement of two transpapillary cystic duct stents reduce the risk of recurrent symptomatic gallbladder disease compared to one stent?
2. Is there a difference in procedure-related adverse events (post-ERCP pancreatitis, cholangitis, stent migration) between the two strategies?
Researchers will compare outcomes between patients randomized to one stent versus two stents to determine which approach provides better long-term gallbladder drainage and fewer recurrent events.
Participants will:
Be evaluated for eligibility and provide informed consent prior to undergoing an endoscopic retrograde cholangiopancreatography (ERCP), an endoscopy where a guidewire is placed into the bile duct from the small intestine.
They will then undergo ERCP with transpapillary cystic duct stent placement, randomized to one or two stents.
All participants will receive standard post-procedure care and follow-up assessments for recurrence, adverse events, and need for reintervention.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ONE STENT ARM | Active comparator | Procedure: ERCP with one stent placement | Participant assigned to this Arm will undergo ERCP and have one transpapillary duct stent placed for the treatment of symptomatic gallbladder disease |
| TWO STENT ARM | Active comparator | Procedure: ERCP with two stent placement | Participant assigned to this ARM will undergo ERCP and have two transpapillary duct stent placed for the treatment of symptomatic gallbladder disease. |
Sex: All, ages: 18 Years to 95 Years
Inclusion Criteria: 1. Males or non-pregnant females presenting with cholecystitis, biliary colic or gallstone pancreatitis. 2. Age 18-95. 3. Participants must be willing and able to provide informed consent 4. Referred for ERCP for management of 1) suspected choledocholithiasis 2) acute biliary pancreatitis and/or 3) acute cholangitis in whom cholecystectomy is expected to be delayed > 30 days or are deemed to not be surgical candidates for cholecystectomy. Exclusion Criteria: 1. Inability to provide informed consent 2. History of surgically altered upper gastrointestinal anatomy (e.g. Roux-en-Y gastric bypass, Billroth I/II) precluding standard ERCP 3. History of primary sclerosing cholangitis 4. History of gallbladder cancer 5. History of cholecystectomy 6. Unsuccessful biliary cannulation during ERCP -
| Facility | City | Country | Status |
|---|---|---|---|
| Mayo Clinic | Rochester, Minnesota | United States | Recruiting |