One vs. Two Stents for Gallbladder Disease

NCT07222527 | Recruiting DMC

• 2 other identifiers: 24-01141095352001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Does placement of two transpapillary cystic duct stents reduce the risk of recurrent symptomatic gallbladder disease compared to one stent?
2. 2.Is there a difference in procedure-related adverse events (post-ERCP pancreatitis, cholangitis, stent migration) between the two strategies?

Conditions

Cholecystitis; Symptomatic Gallbladder Disease; Biliary Colic; Recurrent Cholecystitis

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

Outcome Measures

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.

  6 months

Secondary Outcomes (4)

• Technical Success

  1 day

• Time to Recurrence

  6 months

• Reintervention

  6 months

• Adverse Events

  6 months

Study Arms (2)

ONE STENT ARM

ACTIVE COMPARATOR

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

TWO STENT ARM

ACTIVE COMPARATOR

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

Interventions

ERCP with two stent placement PROCEDURE

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

TWO STENT ARM

ERCP with one stent placement PROCEDURE

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

ONE STENT ARM

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• History of cholecystectomy
• Unsuccessful biliary cannulation during ERCP -

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33798540 RESULT

MeSH Terms

Conditions

Cholecystitis; Gallbladder Diseases

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Eric Vargas

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liz Lemke

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 30, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): May 27, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after publication of results to 5 years after publication

Locations

US (1)