NCT01601639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

May 14, 2012

Last Update Submit

January 24, 2017

Conditions

Gastric Antral Vascular Ectasia

Keywords

Gastric Antral Vascular EctasiaArgon plasma CoagulationEndoscopic Band LigationGAVE

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (5)

  • Number of sessions required for GAVE eradication

    one year

  • Total procedure time

    one year

  • Blood transfusion requirements

    one year

  • Iron studies

    one year

  • Ferritin

    one year

Study Arms (2)

Argon Plasma Coagulation

ACTIVE COMPARATOR

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

Device: Argon plasma Coagulation (APC) for GAVE

Endoscopic Band Ligation

ACTIVE COMPARATOR

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

Device: Endoscopic Band Ligation

Interventions

Endoscopic Band LigationDEVICE

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

Endoscopic Band Ligation
Argon plasma Coagulation (APC) for GAVEDEVICE

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

Argon Plasma Coagulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients with GAVE identified at endoscopic examination, patients may have active GI bleeding, chronic anemia or drop in hemoglobin levels.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G2X8, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25650636RESULT

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia

Interventions

Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesAngiodysplasiaVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ElectrocoagulationCauteryTherapeuticsHemostatic TechniquesAblation TechniquesSurgical Procedures, OperativeHemostasis, Surgical

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Division of Gastroenterology

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 18, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

CA(2)