One vs. Two Stents for Gallbladder Disease

🩺 Protocol Summary

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.

Primary Research Facility: Mayo Clinic (Rochester, Minnesota)

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Recurrent Cholecystitis?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged between 18 Years and 95 Years?

🔍 Protocol Specified Age Range: 18 Years to 95 Years

Able to attend required clinic visits at Mayo Clinic (Rochester, Minnesota)?

🔍 Logistical Requirement: Site at Mayo Clinic

📍 Primary Site Map

Site: Mayo Clinic — Rochester, Minnesota

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.