Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
NCT Number: NCT07222527
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.
Interested in participating?
Request Info18 year–95 year
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One transpapillary cystic duct stent will be placed into the gallbladder via ERCP
Two transpapillary cystic duct stents will be placed into the gallbladder via ERCP
Time frame: 6 months
Defined as absence of recurrence of symptomatic gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) at 6 months post-procedure.
Time frame: 1 day
Defined as the ability to place the allocated number of transpapillary double pigtail stents into the gallbladder.
Time frame: 6 months
The amount of time (days) from the index procedure to when a recurrence occurs
Time frame: 6 months
The proportion of participants who receive another endoscopic procedure due to failure/adverse events related to the index procedure
Time frame: 6 months
The type and severity of adverse events that occur related to the index procedure for stent placement
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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