Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04915651 |
Other study ID # |
1904567382 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2021 |
Est. completion date |
July 1, 2023 |
Study information
Verified date |
June 2021 |
Source |
University of Arizona |
Contact |
Hugh McGregor, MD |
Phone |
520-626-1069 |
Email |
hughcjmcgregor[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.