One vs. Two Stents for Gallbladder Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ERCP with one stent placement
Procedure/SurgeryOne transpapillary cystic duct stent will be placed into the gallbladder via ERCP
ERCP with two stent placement
Procedure/SurgeryTwo transpapillary cystic duct stents will be placed into the gallbladder via ERCP
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: ONE STENT ARMActive comparator 1 intervention
Group B: TWO STENT ARMActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Technical Success
Defined as the ability to place the allocated number of transpapillary double pigtail stents into the gallbladder.
Time frame
1 day2
Time to Recurrence
The amount of time (days) from the index procedure to when a recurrence occurs
Time frame
6 months3
Reintervention
The proportion of participants who receive another endoscopic procedure due to failure/adverse events related to the index procedure
Time frame
6 months4
Adverse Events
The type and severity of adverse events that occur related to the index procedure for stent placement
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov