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

NCT ID: NCT01601639

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Gastric Antral Vascular Ectasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Argon Plasma Coagulation

Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements

Group Type ACTIVE_COMPARATOR

Argon plasma Coagulation (APC) for GAVE

Intervention Type DEVICE

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

Endoscopic Band Ligation

Patients with GAVE and/or chronic anemia, active GI bleeding, blood transfusion requirements

Group Type ACTIVE_COMPARATOR

Endoscopic Band Ligation

Intervention Type DEVICE

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

Interventions

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Endoscopic Band Ligation

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

Intervention Type DEVICE

Argon plasma Coagulation (APC) for GAVE

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Sergio Zepeda

Assistant Professor, Division of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 25650636 (View on PubMed)

Other Identifiers

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Pro00030955

Identifier Type: -

Identifier Source: org_study_id

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