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

Gastric Antral Vascular Ectasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601639
• Other study ID #: Pro00030955
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2012
• Last updated: January 24, 2017
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: January 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Antral Vascular Ectasia

Intervention

Device:
• Endoscopic Band Ligation
Endoscopic band ligation device: 6 Shooter Saeed Multi-Band Ligator (Cook Medical/Endoscopy)
• Argon plasma Coagulation (APC) for GAVE
APC treatment for gastric antral vascular ectasia (GAVE) Argon plasma coagulation device: ERBE VIO 300D (Elektromedizin GmBH)

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Zepeda-Gómez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of sessions required for GAVE eradication	The total number of endoscopic sessions required for total disappearance of the gastric antral vascular ectasia (GAVE)	one year
Secondary	Total procedure time	The investigators will document the total endoscopy time required for each procedure to compare between the two devices	one year
Secondary	Blood transfusion requirements	The number of blood transfusions will be documented for each patient before and after the endoscopic treatment	one year
Secondary	Iron studies	Iron levels changes in blood serum will be monitored throughout the study.	one year
Secondary	Ferritin	Changes in ferritin levels will be monitored during the study	one year