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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07222527
The ClinicalTrials.gov registry entry for NCT07222527 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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