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


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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2013

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.


  • Device: Endoscopic Band Ligation
    • Endoscopic band ligation device: 6 Shooter Saeed Multi-Band Ligator (Cook Medical/Endoscopy)
  • Device: Argon plasma Coagulation (APC) for GAVE
    • APC treatment for gastric antral vascular ectasia (GAVE) Argon plasma coagulation device: ERBE VIO 300D (Elektromedizin GmBH)

Arms, Groups and Cohorts

  • Active Comparator: Argon Plasma Coagulation
    • Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
  • Active Comparator: Endoscopic Band Ligation
    • Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements

Clinical Trial Outcome Measures

Primary Measures

  • New event of upper gastrointestinal bleeding
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 90 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University of Alberta
    • Provider of Information About this Clinical Study
      • Principal Investigator: Sergio Zepeda, Assistant Professor, Division of Gastroenterology – University of Alberta

    Citations Reporting on Results

    Zepeda-Gómez S, Sultanian R, Teshima C, Sandha G, Van Zanten S, Montano-Loza AJ. Gastric antral vascular ectasia: a prospective study of treatment with endoscopic band ligation. Endoscopy. 2015 Jun;47(6):538-40. doi: 10.1055/s-0034-1391395. Epub 2015 Feb 4.

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