One vs. Two Stents for Gallbladder Disease

NCT ID: NCT07222527

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2028-05-27

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ERCP with one stent placement

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

ERCP with two stent placement

Intervention Type: PROCEDURE

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

Interventions

ERCP with one stent placement

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

Intervention Type: PROCEDURE

ERCP with two stent placement

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

Intervention Type: PROCEDURE

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Eric J. Vargas Valls

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Vargas

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Central Contacts

Liz Lemke

Role: CONTACT

Phone: 507-266-3317

Email: Lemke.Elizabeth@mayo.edu

Facility Contacts

Liz Lemke

Role: primary

References

Storm AC, Vargas EJ, Chin JY, Chandrasekhara V, Abu Dayyeh BK, Levy MJ, Martin JA, Topazian MD, Andrews JC, Schiller HJ, Kamath PS, Petersen BT. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. 2021 Oct;94(4):742-748.e1. doi: 10.1016/j.gie.2021.03.025. Epub 2021 Mar 30.

Reference Type: RESULT

PMID: 33798540 (View on PubMed)

Other Identifiers

95352001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-011410

Identifier Type: -

Identifier Source: org_study_id