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

U

University of Alberta

Status and phase

Completed
Phase 3

Conditions

Gastric Antral Vascular Ectasia

Treatments

Device: Endoscopic Band Ligation
Device: Argon plasma Coagulation (APC) for GAVE

Study type

Interventional

Funder types

Other

Identifiers

NCT01601639
Pro00030955

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Argon Plasma Coagulation
Active Comparator group
Description:
Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
Treatment:
Device: Argon plasma Coagulation (APC) for GAVE
Endoscopic Band Ligation
Active Comparator group
Description:
Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements
Treatment:
Device: Endoscopic Band Ligation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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