One vs. Two Stents for Gallbladder Disease

Not Applicable

Not yet recruiting

• Conditions: Recurrent Cholecystitis; Cholecystitis; Symptomatic Gallbladder Disease; Biliary Colic

• Registration Number: NCT07222527
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-28
• Study First Submitted QC: 2025-10-28
• Last Update Submitted: 2025-10-29
• Study First Posted: 2025-10-30
• Last Update Posted: 2025-10-31
• Study Start: 2025-11-15
• Primary Completion: 2027-05-27
• Study Completion: 2028-05-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Success	6 months	Defined as absence of recurrence of symptomatic gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) at 6 months post-procedure.

Secondary Outcome Measures

Name	Time	Method
Technical Success	1 day	Defined as the ability to place the allocated number of transpapillary double pigtail stents into the gallbladder.
Time to Recurrence	6 months	The amount of time (days) from the index procedure to when a recurrence occurs
Reintervention	6 months	The proportion of participants who receive another endoscopic procedure due to failure/adverse events related to the index procedure
Adverse Events	6 months	The type and severity of adverse events that occur related to the index procedure for stent placement

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States