Gallbladder Cryoablation in High-Risk Patients

Sponsor

University of Arizona (Other)

Overall Status

Recruiting

CT.gov ID

NCT04915651

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gallbladder Diseases Cholecystitis Biliary Colic Gallstone; Cholecystitis Biliary Dyskinesia Gallstone Gall Bladder Pain	Device: Gallbladder Cryoablation	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Study of Gallbladder Cryoablation in High-Risk Surgical Patients

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gallbladder Cryoablation High-risk patients who undergo gallbladder cryoablation	Device: Gallbladder Cryoablation Percutaneous cryoablation of the gallbladder.

Arm

Intervention/Treatment

Experimental: Gallbladder Cryoablation

High-risk patients who undergo gallbladder cryoablation

Device: Gallbladder Cryoablation

Percutaneous cryoablation of the gallbladder.

Outcome Measures

Primary Outcome Measures

Symptomatic relief [Up to 2 years after procedure]
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.
Complications [Up to 2 years after procedure]
Clavien-Dindo classification complications

Secondary Outcome Measures

Imaging [Up to 2 years after procedure]
Imaging evidence of gallbladder devitalization and fibrosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.