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NCT Number: NCT01601639

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.

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Key information

Conditions

Gastric Antral Vascular Ectasia Angiodysplasia Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Band Ligation

Device

Endoscopic band ligation device: 6 Shooter Saeed Multi-Band Ligator (Cook Medical/Endoscopy)

Argon plasma Coagulation (APC) for GAVE

Device

APC treatment for gastric antral vascular ectasia (GAVE) Argon plasma coagulation device: ERBE VIO 300D (Elektromedizin GmBH)

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

  3. Blood transfusion requirements

    Time frame: one year

    The number of blood transfusions will be documented for each patient before and after the endoscopic treatment

  4. Iron studies

    Time frame: one year

    Iron levels changes in blood serum will be monitored throughout the study.

  5. Ferritin

    Time frame: one year

    Changes in ferritin levels will be monitored during the study

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 18, 2012
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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