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

Phase 3

Completed

• Conditions: Gastric Antral Vascular Ectasia
• Interventions: Device: Argon plasma Coagulation (APC) for GAVE; Device: Endoscopic Band Ligation

• Registration Number: NCT01601639
• Lead Sponsor: University of Alberta

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-18
• Study Start: 2012-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Argon Plasma Coagulation	Argon plasma Coagulation (APC) for GAVE	Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
Endoscopic Band Ligation	Endoscopic Band Ligation	Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements

Primary Outcome Measures

Name	Time	Method
New event of upper gastrointestinal bleeding	one year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada