Gallbladder Cryoablation in High-Risk Patients
Primary Purpose
Gallbladder Diseases, Cholecystitis, Biliary Colic
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gallbladder Cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Gallbladder Diseases focused on measuring cryoablation, gallstones, gallbladder, cholecystitis
Eligibility Criteria
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.
Sites / Locations
- University of ArizonaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gallbladder Cryoablation
Arm Description
High-risk patients who undergo gallbladder cryoablation
Outcomes
Primary Outcome Measures
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.
Complications
Clavien-Dindo classification complications
Secondary Outcome Measures
Imaging
Imaging evidence of gallbladder devitalization and fibrosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04915651
Brief Title
Gallbladder Cryoablation in High-Risk Patients
Official Title
Prospective Study of Gallbladder Cryoablation in High-Risk Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Diseases, Cholecystitis, Biliary Colic, Gallstone; Cholecystitis, Biliary Dyskinesia, Gallstone, Gall Bladder Pain
Keywords
cryoablation, gallstones, gallbladder, cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gallbladder Cryoablation
Arm Type
Experimental
Arm Description
High-risk patients who undergo gallbladder cryoablation
Intervention Type
Device
Intervention Name(s)
Gallbladder Cryoablation
Intervention Description
Percutaneous cryoablation of the gallbladder.
Primary Outcome Measure Information:
Title
Symptomatic relief
Description
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.
Time Frame
Up to 2 years after procedure
Title
Complications
Description
Clavien-Dindo classification complications
Time Frame
Up to 2 years after procedure
Secondary Outcome Measure Information:
Title
Imaging
Description
Imaging evidence of gallbladder devitalization and fibrosis
Time Frame
Up to 2 years after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hugh McGregor, MD
Phone
520-626-1069
Email
hughcjmcgregor@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh McGregor, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugh McGregor, MD
Phone
520-626-1069
Email
hughcjmcgregor@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Gallbladder Cryoablation in High-Risk Patients
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