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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Alberta

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • Number of sessions required for GAVE eradication [ Time Frame: one year ]
    The total number of endoscopic sessions required for total dissapearance 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


Information By: University of Alberta

Dates:
Date Received: May 14, 2012
Date Started: September 2012
Date Completion:
Last Updated: January 24, 2017
Last Verified: January 2017