Gallbladder Cryoablation in High-Risk Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gallbladder Diseases Cholecystitis Biliary Colic Gallstone; Cholecystitis Biliary Dyskinesia Gallstone Gall Bladder Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gallbladder Cryoablation

High-risk patients who undergo gallbladder cryoablation

Group Type EXPERIMENTAL

Gallbladder Cryoablation

Intervention Type DEVICE

Percutaneous cryoablation of the gallbladder.

Interventions

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Gallbladder Cryoablation

Percutaneous cryoablation of the gallbladder.

Intervention Type DEVICE

Eligibility Criteria

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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.