Gallbladder Cryoablation in High-Risk Patients

Cholecystitis Clinical Trial

Official title:

Prospective Study of Gallbladder Cryoablation in High-Risk Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04915651
• Other study ID #: 1904567382
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2021
• Source: University of Arizona
• Contact: Hugh McGregor, MD
• Phone: 520-626-1069
• Email: hughcjmcgregor[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of the proposed research is to evaluate the outcomes of gallbladder cryoablation in high-risk surgical candidates with benign gallbladder disease (acute cholecystitis, chronic cholecystitis, biliary dyskinesia, biliary colic).

Specific Aim:

Aim 1: To evaluate the safety and efficacy of gallbladder cryoablation in high-risk surgical candidates. Patients who undergo gallbladder cryoablation will be followed long-term according to standard of care. This includes scheduled clinic follow up, laboratory analysis, and imaging as needed. We hypothesize that gallbladder cryoablation is a safe and effective treatment for high-risk surgical patients with benign gallbladder disease. Clinically, we hypothesize that patients will be free from any clinical symptoms or signs after gallbladder cryoablation and removal of a cholecystostomy tube. These include, but are not limited to right upper quadrant pain, fever, chills, and jaundice.

Aim 2: To evaluate the imaging changes seen in the gallbladder after cryoablation. Imaging is part of routine follow up after percutaneous ablation and may include CT, MRI, and nuclear medicine studies as needed. We hypothesize that after cryoablation, patients will be functionally acholecystic, which occlusion of the cystic duct and involution and fibrosis of the gallbladder demonstrated by imaging.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Colic
• Biliary Dyskinesia
• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Dyskinesias
• Gallbladder Diseases
• Gallstone
• Gallstones

Intervention

Device:
• Gallbladder Cryoablation
Percutaneous cryoablation of the gallbladder.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic relief	Absence of right upper quadrant abdominal pain and nausea and absence of repeat episodes of cholecystitis, which would manifest as right upper quadrant abdominal pain associated with a fever (>100 C) and leukocytosis.	Up to 2 years after procedure
Primary	Complications	Clavien-Dindo classification complications	Up to 2 years after procedure
Secondary	Imaging	Imaging evidence of gallbladder devitalization and fibrosis	Up to 2 years after procedure