Endoscopic Band Ligation Versus Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial

Study Overview
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Brief Summary
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The investigators goal is to compare the standard argon plasma coagulation (APC) treatment with endoscopic band ligation (EBL) in patients with Gastric Antral Vascular Ectasia.

Detailed Description
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Gastric antral vascular ectasia (GAVE) is a vascular structural malformation in the stomach that can lead to active or chronic intermittent gastrointestinal bleeding or chronic iron-deficiency anemia. The current standard endoscopic treatment is with APC. There have been multiple reports and case series in the literature about successful treatment with EBL for GAVE, even in cases where APC was unsuccessful for treatment of GAVE. Our goal is to compare the standard APC treatment with EBL in patients with Gastric Antral Vascular Ectasia.

Official Title
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Endoscopic Band Ligation vs Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial

Conditions
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Gastric Antral Vascular Ectasia

Intervention / Treatment
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* Device: Endoscopic Band Ligation
* Device: Argon plasma Coagulation (APC) for GAVE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients with GAVE identified at endoscopic examination, patients may have active GI bleeding, chronic anemia or drop in hemoglobin levels. Exclusion Criteria: Patients with previous endoscopic treatment for GAVE within the last 3 months, patients with GAVE without chronic anemia or active bleeding, patients in whom another possible source of GI bleeding is found

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Argon Plasma Coagulation<br>Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements | Device: Argon plasma Coagulation (APC) for GAVE<br>* APC treatment for gastric antral vascular ectasia (GAVE) Argon plasma coagulation device: ERBE VIO 300D (Elektromedizin GmBH)<br>|
| Active Comparator: Endoscopic Band Ligation<br>Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements | Device: Endoscopic Band Ligation<br>* Endoscopic band ligation device: 6 Shooter Saeed Multi-Band Ligator (Cook Medical/Endoscopy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New event of upper gastrointestinal bleeding | Number of new episodes of upper gastrointestinal bleeding characterized by melena, hematemesis or quick and significant drop in hemoglobin levels will be documented after the first session of therapy.The hemoglobin level will be recorded before the procedure and 4,8,and 12 weeks after the first endoscopic treatment for GAVE to document changes from baseline. Patients showing stabilization of hemoglobin levels (no significant drop or improvement in levels) without other signs of gastrointestinal bleeding will be considered as treatment success. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sessions required for GAVE eradication | The total number of endoscopic sessions required for total disappearance of the gastric antral vascular ectasia (GAVE) | one year | 
| Total procedure time | The investigators will document the total endoscopy time required for each procedure to compare between the two devices | one year | 
| Blood transfusion requirements | The number of blood transfusions will be documented for each patient before and after the endoscopic treatment | one year | 
| Iron studies | Iron levels changes in blood serum will be monitored throughout the study. | one year | 
| Ferritin | Changes in ferritin levels will be monitored during the study | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Antral Vascular Ectasia, Argon plasma Coagulation, Endoscopic Band Ligation, GAVE