Cryotherapy for GAVE

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

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

Intervention / Treatment
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* Device: cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects with GAVE will undergo therapy with a cryotherapy device
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GAVE, cryotherapy, bleeding, stomach, gastric, EGD, endoscopy