Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

Portal Hypertension Clinical Trial

Official title:

Control of Acute Variceal Bleeding Using the Multi-shooter Band Ligator Compared to Injection Sclerotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131962
• Other study ID #: egsbl1
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2010
• Last updated: December 3, 2014
• Start date: May 2008
• Est. completion date: July 2012

Study information

• Verified date: December 2014
• Source: Faculty of Medicine, University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

Band ligation and injection sclerotherapy are two modalities of treatment that are applied using the endoscope. The purpose of this study is to determine which of two methods is better for controlling bleeding from the upper gut.

Description:

The use of band ligation for endoscopy during the attack of hematemesis is a novel practice as opposed to injection sclerotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active hematemesis

• esophageal varices

Exclusion Criteria:

• Hemodynamic unstability

• Hepatic coma or precoma

• Tense ascitis

• Coagulopathies

• concomitant gastric varices

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematemesis
• Hypertension, Portal
• Portal Hypertension

Intervention

Procedure:
• Endoscopic control of hematemesis
Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy

Locations

Country	Name	City	State
Egypt	Hematemesis unit, Alexandria Main University Hospital, Azarita	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	control of hematemesis	Success for either techniques to be able to stop the bleeding promptly and maintain that for 72 hours	72 hours	No
Secondary	occurence of complications from the intervention	the study subjects are reveiwed in 30 days to detect any complications secondary to the endoscopic intervention.	30 days	Yes