Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07222527

One vs. Two Stents for Gallbladder Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Eric Vargas

PRINCIPAL_INVESTIGATOR

Liz Lemke

CONTACT

[email protected]

507-266-3317

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 -

Treatment and study plan

ERCP with one stent placement

Procedure

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

ERCP with two stent placement

Procedure

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

Primary outcomes

  1. Clinical Success

    Time frame: 6 months

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

Secondary outcomes

  1. Technical Success

    Time frame: 1 day

    Defined as the ability to place the allocated number of transpapillary double pigtail stents into the gallbladder.

  2. Time to Recurrence

    Time frame: 6 months

    The amount of time (days) from the index procedure to when a recurrence occurs

  3. Reintervention

    Time frame: 6 months

    The proportion of participants who receive another endoscopic procedure due to failure/adverse events related to the index procedure

  4. Adverse Events

    Time frame: 6 months

    The type and severity of adverse events that occur related to the index procedure for stent placement

Study contacts

Contact information is provided by the study sponsor or research team.

Liz Lemke

CONTACT

[email protected]

507-266-3317

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 30, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.