One versus two cystic duct stents for preventing repeat gallbladder attacks
Official title: A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates
Run by Mayo Clinic · NCT07222527 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 95 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | December 12, 2025 |
| Main results expected | May 27, 2027 |
| Study ends | May 27, 2028 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT07222527 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Eric Vargas — Mayo Clinic
- Study coordinator: Liz Lemke
- Email: Lemke.Elizabeth@mayo.edu
- Phone: 507-266-3317
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.