One vs. Two Stents for Gallbladder Disease

A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates

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.

Study Overview

• Status: Recruiting
• Conditions: Cholecystitis; Biliary Colic; Symptomatic Gallbladder Disease; Recurrent Cholecystitis
• Intervention / Treatment: Procedure: ERCP with one stent placement; Procedure: ERCP with two stent placement

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liz Lemke; Phone Number: 507-266-3317; Email: Lemke.Elizabeth@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Liz Lemke; Phone Number: 507-266-3317; Email: Lemke.Elizabeth@mayo.edu
      • Principal Investigator: Eric Vargas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Eric Vargas, Mayo Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): May 27, 2028

Study Registration Dates

• First Submitted: October 28, 2025
• First Submitted That Met QC Criteria: October 28, 2025
• First Posted (Estimated): October 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Diagnostic Imaging; Radiography; Cholangiography; Radiography, Abdominal; Cholangiopancreatography, Endoscopic Retrograde
• Other Study ID Numbers: 24-011410; 95352001 (Other Grant/Funding Number: Mayo Clinic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data and outcomes will be shared after study approval of request from investigators by the study team
• IPD Sharing Time Frame: 1 year after publication of results to 5 years after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No