An interventional study of ERCP with one stent placement and ERCP with two stent placement in Recurrent Cholecystitis, Cholecystitis and Symptomatic Gallbladder Disease, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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:
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.
192 studies on the registry are indexed under Cholecystitis; 36 are open to participants now.
This study's planned enrollment of 30 is below the median of 82 across 129 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant assigned to this Arm will undergo ERCP and have one transpapillary duct stent placed for the treatment of symptomatic gallbladder disease
Procedure: ERCP with one stent placement
Participant assigned to this ARM will undergo ERCP and have two transpapillary duct stent placed for the treatment of symptomatic gallbladder disease.
Procedure: ERCP with two stent placement
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
Clinical Success
Defined as absence of recurrence of symptomatic gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) at 6 months post-procedure.
Time frame: 6 months
Technical Success
Defined as the ability to place the allocated number of transpapillary double pigtail stents into the gallbladder.
Time frame: 1 day
Time to Recurrence
The amount of time (days) from the index procedure to when a recurrence occurs
Time frame: 6 months
Reintervention
The proportion of participants who receive another endoscopic procedure due to failure/adverse events related to the index procedure
Time frame: 6 months
Adverse Events
The type and severity of adverse events that occur related to the index procedure for stent placement
Time frame: 6 months
Plan to share: Yes — Deidentified participant data and outcomes will be shared after study approval of request from investigators by the study team
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 1 year after publication of results to 5 years after publication
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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