Cryotherapy for GAVE

Withdrawn before enrolling · Not applicable

Conditions studied: GAVE - Gastric Antral Vascular Ectasia, Bleeding, Bleeding Gastric

In brief

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.

Key facts

Study ID: NCT04760873
Run by: H. Lee Moffitt Cancer Center and Research Institute
People needed: 0
Starts: 2020-10-14
Expected to finish: 2024-01-22
Last updated by the study team: 2024-12-05

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
Long Island Jewish Medical Center — New Hyde Park, New York, United States
Columbia University Medical Center-NYPH — New York, New York, United States
Cleveland Clinic Foundation of America — Cleveland, Ohio, United States
Geisinger Medical Center — Danville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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