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NCT07222527 · ClinicalTrials.gov registry record · NA
One vs. Two Stents for Gallbladder Disease
A NA study of Cholecystitis and Biliary Colic, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07222527: Recruiting NA study of Cholecystitis and Biliary Colic, sponsored by Mayo Clinic.
NCT07222527 is a NA study of Cholecystitis and Biliary Colic that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07222527, a NA study of Cholecystitis and Biliary Colic, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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 Outcome
Defined as absence of recurrence of symptomatic gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) at 6 months post-procedure.
Conditions Studied
Interventions
- PROCEDURE ERCP with one stent placement
- PROCEDURE ERCP with two stent placement
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-12-12 |
| Est. Completion | 2028-05-27 |
| Phase | NA |
What NCT07222527 shows while recruiting
NCT07222527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Cholecystitis appearing as the primary indexed condition, and to 2 interventions - of which ERCP with one stent placement is the first listed.
NCT07222527 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT07222527 about?
NCT07222527 is a clinical study titled "One vs. Two Stents for Gallbladder Disease". 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 g...
What is the current status of trial NCT07222527?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2025-12-12. Estimated completion is 2028-05-27.
What conditions does trial NCT07222527 study?
This clinical trial studies the following conditions: Cholecystitis, Biliary Colic, Recurrent Cholecystitis, Symptomatic Gallbladder Disease.
What interventions are being tested in trial NCT07222527?
The interventions under investigation include: ERCP with one stent placement (PROCEDURE), ERCP with two stent placement (PROCEDURE).
Who is sponsoring clinical trial NCT07222527?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07222527 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07222527's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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