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 ]
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