Recruiting

One vs. Two Stents

Sponsor:

Mayo Clinic

Code:

NCT07222527

Conditions

Recurrent Cholecystitis

Cholecystitis

Symptomatic Gallbladder Disease

Biliary Colic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ERCP with one stent placement

ERCP with two stent placement

Study Details

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.

Conditions

Recurrent Cholecystitis

Cholecystitis

Symptomatic Gallbladder Disease

Biliary Colic

Study ID

NCT07222527

Start date

Dec 12, 2025

Status verified date

Dec, 2025

Completion date

May 27, 2028

Anticipated

Primary completion date

May 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

Interventions

ERCP with one stent placement

One transpapillary cystic duct stent will be placed into the gallbladder via ERCP

ERCP with two stent placement

Two transpapillary cystic duct stents will be placed into the gallbladder via ERCP

Primary outcome measure

  • Clinical Success [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Eric Vargas

More Information

Sponsor

Mayo Clinic

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • gallbladder disease
  • symptomatic gallbladder disease
  • Recurrent cholecystitis
  • biliary colic
  • cystic duct stent
  • transpapillary gallbladder stents
  • high surgical risk patient
  • nonsurgical management gallbladder disease
  • gallbladder decompression
  • acute cholecystitis in non-cholecystectomy candidate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-12-16.