Cryotherapy for GAVE (GAVE Cryo)

March 4, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute

Gastric Antral Vascular Ectasia Treatment With Balloon Cryotherapy: A Multicenter Prospective Trial

Gastric antral vascular ectasia (GAVE) is a condition that can lead to blood loss in the gastrointestinal tract and low blood counts or anemia. 1,2 GAVE is commonly associated with liver disease, kidney disease and autoimmune immune problems, but can also be seen in patients without those problems. 2-4 It is common for GAVE to cause hospitalization of patients and significant blood transfusion requirements. Given these problems, effective treatment of GAVE is needed to reduce these potential problems.

These treatments are performed by a gastroenterologist through a flexible endoscope most often with argon plasma coagulation (APC).5-7 APC is only partially successful at eradicating GAVE and often entails repeated endoscopic procedures. Therapy with APC can also cause ulceration at times resulting in acute bleeding. Cryoablation is an attractive alternative to APC as it should not cause increased blood loss and case reports suggest that ablation may be achieved with limited number of endoscopic sessions. Prior problems with endoscopic cryotherapy include the high flow of gas and risk of perforation.8,9 A recent retrospective investigation by this group has evaluated the first generation cryotherapy balloon, demonstrating clinical safety and efficacy for GAVE.10 A new balloon cryotherapy spray device was recently developed and does not require venting. In this study we plan to prospectively evaluate the use of balloon cryotherapy to treat GAVE. We predict that the therapeutic response of balloon cryotherapy will be greater than 80% effective at achieving clinical success or the loss of overt bleeding and need for packed red blood cell (PRBC) transfusion at 6 months after treatment.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Gastric antral vascular ectasia (GAVE), classically termed "watermelon stomach," is a condition of chronic acute blood loss in the gastrointestinal (GI) tract and can lead to common utilization of packed red blood cell (PRBC) transfusion. This condition occurs in 0.3% of endoscopic studies and 4% of studies performed for chronic or acute blood loss anemia.1,2 GAVE is commonly associated with autoimmune disease in 60% of cases and chronic liver disease in 30% of cases.2-4 Given the association with chronic liver disease, GAVE can be mistaken for other GI pathologies such as portal hypertensive gastropathy (PHG).11,12 Therefore, identification of GAVE is important in the management of this condition.

Historically there have been 1 series highlighting the use of a monopolar probe and heater probe to treat GAVE. As these therapies have a low depth of thermal penetration, these therapies are not commonly utilized for GAVE.13,14 The most commonly implemented endoscopic therapy is argon plasma coagulation (APC). Among the largest studies of APC, the efficacy for treatment of GAVE is variable5,6 Additional outcomes include a reduction in the number of PRBC transfused in patients with GAVE that were treated with APC.7 In addition to APC, radiofrequency ablation (RFA) has also been evaluated in the setting of GAVE, leading to a decrease in the transfusions needed during follow-up.15 Similarly, cryotherapy using a spray catheter has been evaluated for GAVE.8,9 In these studies, the patients did demonstrate endoscopic improvement, lower transfusion requirements, and normalization of their hemoglobin. Despite, these results, the spray cryotherapy device requires the use of a venting tube to prevent complications and carries with it technical limitations that can make ablation difficult. Our study group, which includes University Hospitals, Case Western Reserve, Long Island Jewish Medical Center, Geisinger Medical Center, Columbia University Medical Center and The Cleveland Clinic Foundation of America This group has recently evaluated the first generation balloon cryotherapy device for GAVE, demonstrating efficacy and safety.10 Therefore, in this study we set out to prospectively evaluate the efficacy of a new balloon cryotherapy device for the treatment of GAVE. We predict that balloon cryotherapy will lead to greater than 80% clinical success (need for PRBC transfusion and absent overt bleeding).

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • New York
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center-NYPH
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation of America
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Have GAVE
  2. Have had treatment discussion with non-study team member (physician or GI advanced practice provider) of alternatives and have elected Cryotherapy
  3. Patients with signs of GI bleeding defined as hemoglobin drop > 2 grams/dL, need for PRBC transfusion or overt bleeding (melena, hematemesis, hematochezia)
  4. Patients undergoing EGD with Ablation for GAVE (treatment naïve, RFA, banding, APC failures)
  5. Patients who underwent their last ablation at least 4 weeks prior
  6. Platelet count > 40,000
  7. International normalized ratio (INR) < 1.5
  8. Age > 18 years and < 90 years

Exclusion Criteria:

  1. Age < 18 years OR > 90 years
  2. Inability to obtain consent
  3. Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
  4. Platelet count < 40,000
  5. INR > 1.5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryotherapy for GAVE
Subjects will undergo cryotherapy for GAVE
Device: cryotherapy
cryotherapy is a freeze spray that will be applied to GAVE for bleeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: 6 months
defined by the absence of PRBC transfusions and clinical evidence of bleeding
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 6 months
defined as the ability to treat > 75% of the endoscopic area
6 months
Endoscopic success
Time Frame: 6 months
defined as resolution of > 75% of the visible GAVE endoscopic surface
6 months
Mean/total number of PRBC transfused
Time Frame: 6 months
transfusion of packed red blood cells
6 months
Change in hemoglobin
Time Frame: 6 months
change in the lab test hemoglobin in grams/deciLiter
6 months
Technical failure
Time Frame: 6 months
defined as the need for additional ablative modalities to achieve the primary study outcome
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Columbia University
University Hospitals Cleveland Medical Center
Geisinger Clinic
Long Island Jewish Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Estimated)

August 12, 2024

Study Completion (Estimated)

August 12, 2024

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20181169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Electronic health records database will allow for availability of demographic data and office-based follow-up records. ProVation MD software information will provide details regarding endoscopic parameters and intervention performed.

Electronic records gathered for study purposes will only be available to study investigators and will be stored on an encrypted hard drive on a computer. Data will initially be entered with PHI attached so that all information can be obtained. Once all data collection is complete identifiers will be removed and random number assigned to the patients.

Paper copies of study consents will be filled out in the endoscopy center and stored in a locked cabinet in the endoscopy center workroom. The door to the workroom with the cabinet is locked after hours and the endoscopy center is locked after hours as well.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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