One versus two cystic duct stents for preventing repeat gallbladder attacks

A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates

This compares one versus two cystic duct stents to see if two stents better prevent repeat gallbladder attacks in adults who are not immediate candidates for gallbladder removal.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 95 Years
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT07222527 on ClinicalTrials.gov

What this trial studies

This randomized trial enrolls adults referred for ERCP with symptomatic gallbladder disease who cannot undergo immediate cholecystectomy or are expected to have surgery delayed more than 30 days. Participants are randomized during ERCP to receive either one transpapillary cystic duct stent or two stents. Investigators will track recurrent symptomatic gallbladder events (cholecystitis, biliary colic, or gallstone pancreatitis), procedure-related complications (post-ERCP pancreatitis, cholangitis, stent migration), and technical success of stent placement. Outcomes will be compared between the two groups to determine whether two stents reduce recurrences or increase adverse events.

Who should consider this trial

Good fit: Adults aged 18–95 with cholecystitis, biliary colic, or gallstone pancreatitis referred for ERCP who cannot undergo immediate cholecystectomy or are expected to have surgery delayed more than 30 days.

Not a fit: Patients with prior cholecystectomy, gallbladder cancer, primary sclerosing cholangitis, surgically altered upper GI anatomy that precludes standard ERCP, or who cannot consent are excluded and unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, using two cystic duct stents could lower the risk of repeat gallbladder attacks and reduce future hospital visits for patients who cannot have immediate surgery.

How similar studies have performed: Endoscopic transpapillary gallbladder stenting has shown symptom control in small series and case reports, but a randomized comparison of one versus two cystic duct stents is largely novel and untested in large trials.

Eligibility criteria

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 -

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Eric Vargas — Mayo Clinic
• Study coordinator: Liz Lemke

Conditions Recurrent Cholecystitis; Cholecystitis; Symptomatic Gallbladder Disease; Biliary Colic; gallbladder disease; symptomatic gallbladder disease; Recurrent cholecystitis; biliary colic