Actively Recruiting
One vs. Two Stents for Gallbladder Disease
Led by Mayo Clinic · Updated on 2025-12-16
30
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
One vs. Two Stents for Gallbladder Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or non-pregnant females presenting with cholecystitis, biliary colic, or gallstone pancreatitis
- Age between 18 and 95 years
- Willing and able to provide informed consent
- Referred for ERCP for suspected choledocholithiasis, acute biliary pancreatitis, or acute cholangitis with delayed cholecystectomy (> 30 days) or deemed non-surgical candidates for cholecystectomy
You will not qualify if you...
- Unable to provide informed consent
- History of surgically altered upper gastrointestinal anatomy preventing standard ERCP (e.g., Roux-en-Y gastric bypass, Billroth I/II)
- History of primary sclerosing cholangitis
- History of gallbladder cancer
- History of cholecystectomy
- Unsuccessful biliary cannulation during ERCP
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
L
Liz Lemke
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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