Gallbladder Cryoablation in High-Risk Patients
Status unconfirmed · Not applicable
Conditions studied: Gallbladder Diseases, Cholecystitis, Biliary Colic, Gallstone; Cholecystitis, Biliary Dyskinesia, Gallstone, Gall Bladder Pain
In brief
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.
Key facts
- Study ID
- NCT04915651
- Run by
- University of Arizona
- People needed
- 20
- Starts
- 2021-07-01
- Expected to finish
- 2023-07-01
- Last updated by the study team
- 2021-06-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- High-risk surgical candidates with benign gallbladder disease who are not eligible for surgical cholecystectomy and are able to consent to study inclusion.
You may not qualify if…
- Patients with benign gallbladder disease who are eligible for surgical cholecystectomy or who are unable to provide informed consent.
Where it is running
- University of Arizona — Tucson, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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