Actively Recruiting

Phase Not Applicable
Age: 18Years - 95Years
All Genders
NCT07222527

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

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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

Age: 18Years - 95Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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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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