Brief Title
Gallbladder Cryoablation in High-Risk Patients
Official Title
Prospective Study of Gallbladder Cryoablation in High-Risk Surgical Patients
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.
Study Type
Interventional
Primary Outcome
Symptomatic relief
Secondary Outcome
Imaging
Condition
Gallbladder Diseases
Intervention
Gallbladder Cryoablation
Study Arms / Comparison Groups
Gallbladder Cryoablation
Description: High-risk patients who undergo gallbladder cryoablation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
20
Start Date
July 1, 2021
Completion Date
July 1, 2023
Primary Completion Date
July 1, 2022
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Hugh McGregor, MD, 520-626-1069, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04915651
Organization ID
1904567382
Responsible Party
Principal Investigator
Study Sponsor
University of Arizona
Study Sponsor
Hugh McGregor, MD, Principal Investigator, University of Arizona
Verification Date
June 2021