Gastric Antral Vascular Ectasia
Conditions
Keywords
Gastric Antral Vascular Ectasia, Argon plasma Coagulation, Endoscopic Band Ligation, GAVE
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.
Interventions
DEVICEEndoscopic Band Ligation
Endoscopic band ligation device: 6 Shooter Saeed Multi-Band Ligator (Cook Medical/Endoscopy)
DEVICEArgon plasma Coagulation (APC) for GAVE
APC treatment for gastric antral vascular ectasia (GAVE) Argon plasma coagulation device: ERBE VIO 300D (Elektromedizin GmBH)
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New event of upper gastrointestinal bleeding | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of sessions required for GAVE eradication | one year | The total number of endoscopic sessions required for total disappearance of the gastric antral vascular ectasia (GAVE) |
| Total procedure time | one year | The investigators will document the total endoscopy time required for each procedure to compare between the two devices |
| Blood transfusion requirements | one year | The number of blood transfusions will be documented for each patient before and after the endoscopic treatment |
| Iron studies | one year | Iron levels changes in blood serum will be monitored throughout the study. |
| Ferritin | one year | Changes in ferritin levels will be monitored during the study |
Countries
Canada
Outcome results
None listed