One vs. Two Stents for Gallbladder Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ERCP with one stent placement, ERCP with two stent placement.
- Who it may be relevant to
- Registry conditions: Recurrent Cholecystitis, Cholecystitis, Symptomatic Gallbladder Disease, Biliary Colic. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates
Overview
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.
Interventions
- Procedure ERCP with one stent placement
One transpapillary cystic duct stent will be placed into the gallbladder via ERCP - Procedure ERCP with two stent placement
Two transpapillary cystic duct stents will be placed into the gallbladder via ERCP
Primary outcome measures
- Clinical Success [Time frame: 6 months]
Secondary outcome measures (4)
- Technical Success [Time frame: 1 day]
- Time to Recurrence [Time frame: 6 months]
- Reintervention [Time frame: 6 months]
- Adverse Events [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Males or non-pregnant females presenting with cholecystitis, biliary colic or gallstone pancreatitis.
- Age 18-95.
- Participants must be willing and able to provide informed consent
- 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
- Inability to provide informed consent
- History of surgically altered upper gastrointestinal anatomy (e.g. Roux-en-Y gastric bypass, Billroth I/II) precluding standard ERCP
- History of primary sclerosing cholangitis
- History of gallbladder cancer
- History of cholecystectomy
- Unsuccessful biliary cannulation during ERCP -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Publications
- Storm AC, Vargas EJ, Chin JY, Chandrasekhara V, Abu Dayyeh BK, Levy MJ, Martin JA, Topazian MD, Andrews JC, Schiller HJ, Kamath PS, Petersen BT. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. 2021 Oct;94(4):742-748.e1. doi: 10.1016/j.gie.2021.03.025. Epub 2021 Mar 30. PMID 33798540
Identifiers
NCT: NCT07222527 · 24-011410 · 95352001