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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sergio Zepeda, University of Alberta
ClinicalTrials.gov Identifier:
NCT01601639
First received: May 14, 2012
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Gastric Antral Vascular Ectasia
Device: Endoscopic Band Ligation
Device: Argon plasma Coagulation (APC) for GAVE
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Band Ligation vs Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • New event of upper gastrointestinal bleeding [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Number of sessions required for GAVE eradication [ Time Frame: one year ] [ Designated as safety issue: No ]
    The total number of endoscopic sessions required for total dissapearance of the gastric antral vascular ectasia (GAVE)

  • Total procedure time [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The number of blood transfusions will be documented for each patient before and after the endoscopic treatment

  • Iron studies [ Time Frame: one year ] [ Designated as safety issue: No ]
    Iron levels changes in blood serum will be monitored throughout the study.

  • Ferritin [ Time Frame: one year ] [ Designated as safety issue: No ]
    Changes in ferritin levels will be monitored during the study


Enrollment: 30
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Argon Plasma Coagulation
Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
Device: Argon plasma Coagulation (APC) for GAVE
APC treatment for gastric antral vascular ectasia (GAVE) Argon plasma coagulation device: ERBE VIO 300D (Elektromedizin GmBH)
Active Comparator: Endoscopic Band Ligation
Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
Device: Endoscopic Band Ligation
Endoscopic band ligation device: 6 Shooter Saeed Multi-Band Ligator (Cook Medical/Endoscopy)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601639

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2X8
Sponsors and Collaborators
University of Alberta
  More Information

No publications provided

Responsible Party: Sergio Zepeda, Assistant Professor, Division of Gastroenterology, University of Alberta
ClinicalTrials.gov Identifier: NCT01601639     History of Changes
Other Study ID Numbers: Pro00030955
Study First Received: May 14, 2012
Last Updated: July 5, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Gastric Antral Vascular Ectasia
Argon plasma Coagulation
Endoscopic Band Ligation
GAVE

Additional relevant MeSH terms:
Dilatation, Pathologic
Gastric Antral Vascular Ectasia
Angiodysplasia
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Pathological Conditions, Anatomical
Stomach Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014