An interventional study of Gallbladder Cryoablation in Gallbladder Diseases, Cholecystitis and Biliary Colic, sponsored by University of Arizona. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-07.
Sponsored by University of Arizona · Not applicable, Interventional, and Treatment
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.
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.
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High-risk patients who undergo gallbladder cryoablation
Device: Gallbladder Cryoablation
Percutaneous cryoablation of the gallbladder.
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.
Time frame: Up to 2 years after procedure
Complications
Clavien-Dindo classification complications
Time frame: Up to 2 years after procedure
Imaging
Imaging evidence of gallbladder devitalization and fibrosis
Time frame: Up to 2 years after procedure
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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