Back to resultsEndoscopic Band Ligation Versus Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial
Primary Purpose
Gastric Antral Vascular Ectasia
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Endoscopic Band Ligation
Argon plasma Coagulation (APC) for GAVE
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Antral Vascular Ectasia focused on measuring Gastric Antral Vascular Ectasia, Argon plasma Coagulation, Endoscopic Band Ligation, GAVE
Eligibility 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
Sites / Locations
- University of Alberta Hospital
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Argon Plasma Coagulation
Endoscopic Band Ligation
Arm Description
Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
Outcomes
Primary Outcome Measures
New event of upper gastrointestinal bleeding
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
The total number of endoscopic sessions required for total disappearance of the gastric antral vascular ectasia (GAVE)
Total procedure time
The investigators will document the total endoscopy time required for each procedure to compare between the two devices
Blood transfusion requirements
The number of blood transfusions will be documented for each patient before and after the endoscopic treatment
Iron studies
Iron levels changes in blood serum will be monitored throughout the study.
Ferritin
Changes in ferritin levels will be monitored during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01601639
Brief Title
Endoscopic Band Ligation Versus Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial
Official Title
Endoscopic Band Ligation vs Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Antral Vascular Ectasia
Keywords
Gastric Antral Vascular Ectasia, Argon plasma Coagulation, Endoscopic Band Ligation, GAVE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Argon Plasma Coagulation
Arm Type
Active Comparator
Arm Description
Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
Arm Title
Endoscopic Band Ligation
Arm Type
Active Comparator
Arm Description
Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
Intervention Type
Device
Intervention Name(s)
Endoscopic Band Ligation
Intervention Description
Endoscopic band ligation device: 6 Shooter Saeed Multi-Band Ligator (Cook Medical/Endoscopy)
Intervention Type
Device
Intervention Name(s)
Argon plasma Coagulation (APC) for GAVE
Intervention Description
APC treatment for gastric antral vascular ectasia (GAVE) Argon plasma coagulation device: ERBE VIO 300D (Elektromedizin GmBH)
Primary Outcome Measure Information:
Title
New event of upper gastrointestinal bleeding
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Number of sessions required for GAVE eradication
Description
The total number of endoscopic sessions required for total disappearance of the gastric antral vascular ectasia (GAVE)
Time Frame
one year
Title
Total procedure time
Description
The investigators will document the total endoscopy time required for each procedure to compare between the two devices
Time Frame
one year
Title
Blood transfusion requirements
Description
The number of blood transfusions will be documented for each patient before and after the endoscopic treatment
Time Frame
one year
Title
Iron studies
Description
Iron levels changes in blood serum will be monitored throughout the study.
Time Frame
one year
Title
Ferritin
Description
Changes in ferritin levels will be monitored during the study
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2X8
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25650636
Citation
Zepeda-Gomez 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.
Results Reference
result
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Endoscopic Band Ligation Versus Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial
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