Gallbladder Cryoablation in High-Risk Patients

Prospective Study of Gallbladder Cryoablation in High-Risk Surgical Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Cholecystitis; Gallbladder Diseases; Biliary Dyskinesia; Biliary Colic; Gallstone; Gall Bladder Pain; Gallstone; Cholecystitis
• Intervention / Treatment: Device: Gallbladder Cryoablation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hugh McGregor, MD; Phone Number: 520-626-1069; Email: hughcjmcgregor@gmail.com

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona
      • Contact: Hugh McGregor, MD; Phone Number: 520-626-1069; Email: hughcjmcgregor@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complications	Clavien-Dindo classification complications	Up to 2 years after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging	Imaging evidence of gallbladder devitalization and fibrosis	Up to 2 years after procedure

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Hugh McGregor, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (ACTUAL): June 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: cryoablation; gallbladder; gallstones; cholecystitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Calculi; Cholecystitis; Acalculous Cholecystitis; Dyskinesias; Gallstones; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases; Biliary Dyskinesia
• Other Study ID Numbers: 1904567382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes