Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 95 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Males or non-pregnant females presenting with cholecystitis, biliary colic or gallstone pancreatitis. 2. Age 18-95. 3. Participants must be willing and able to provide informed consent 4. 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

  1. Inability to provide informed consent 2. History of surgically altered upper gastrointestinal anatomy (e.g. Roux-en-Y gastric bypass, Billroth I/II) precluding standard ERCP 3. History of primary sclerosing cholangitis 4. History of gallbladder cancer 5. History of cholecystectomy 6. Unsuccessful biliary cannulation during ERCP -

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
ONE STENT ARM
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
    One transpapillary cystic duct stent will be placed into the gallbladder via ERCP
Active Comparator
TWO STENT ARM
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
    Two transpapillary cystic duct stents will be placed into the gallbladder via ERCP

Recruiting Locations

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Contact:
Liz Lemke
507-266-3317
Lemke.Elizabeth@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Liz Lemke
507-266-3317
Lemke.Elizabeth@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.