Gallbladder Cryoablation in High-Risk Patients

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Cholecystitis
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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