Recruiting

Gallbladder Cryoablation

Sponsor:

University of Arizona

Code:

NCT04915651

Conditions

Gallbladder Diseases

Cholecystitis

Biliary Colic

Gallstone; Cholecystitis

Biliary Dyskinesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gallbladder Cryoablation

Study Details

Brief summary:

Benign gallbladder disease, including acute cholecystitis, chronic cholecystitis, biliary dyskinesia, and biliary colic, is very common, with over 300,000 surgical cholecystectomies performed per year in the US. Unfortunately, complication rates in elderly patients or patients with many comorbidities are high. These patients are often managed with percutaneous tube drainage of the gallbladder (percutaneous cholecystostomy). The recurrence rate of calculous cholecystitis after cholecystostomy tube removal is as high as 35% at 1 year. These patients are thus faced with permanent cholecystostomy tube drainage, high-risk surgery, or cholecystostomy tube removal and risk of repeat cholecystitis. Gallbladder cryoablation is an alternative to surgical cholecystectomy which is performed percutaneously and does not require general anesthesia. Published evidence on the outcomes of gallbladder cryoablation is however limited at this point in time. The purpose of the proposed study is to follow the outcomes of high-risk patients who undergo gallbladder cryoablation.

Conditions

Gallbladder Diseases

Cholecystitis

Biliary Colic

Gallstone; Cholecystitis

Biliary Dyskinesia

Study ID

NCT04915651

Start date

Jul 1, 2021

Status verified date

Jun, 2021

Completion date

Jul 1, 2023

Anticipated

Primary completion date

Jul 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • High-risk surgical candidates with benign gallbladder disease who are not eligible for surgical cholecystectomy and are able to consent to study inclusion.

Exclusion Criteria:

  • Patients with benign gallbladder disease who are eligible for surgical cholecystectomy or who are unable to provide informed consent.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gallbladder Cryoablation

High-risk patients who undergo gallbladder cryoablation

Interventions

Gallbladder Cryoablation

Percutaneous cryoablation of the gallbladder.

Primary outcome measure

  • Symptomatic relief [ Time Frame: Up to 2 years after procedure ]
  • Complications [ Time Frame: Up to 2 years after procedure ]

Central Contacts and Locations

Central contacts

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

More Information

Sponsor

University of Arizona

Last update posted

Jun 7, 2021

Last verified

Jun, 2021

Keywords

  • cryoablation
  • gallstones
  • gallbladder
  • cholecystitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2021-06-07.