Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

Phase 3

Completed

• Conditions: Portal Hypertension; Hematemesis

• Registration Number: NCT01131962
• Lead Sponsor: University of Alexandria

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Primary Completion: 2011-09
• Study Completion: 2012-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Active hematemesis
• esophageal varices

Exclusion Criteria

• Hemodynamic unstability
• Hepatic coma or precoma
• Tense ascitis
• Coagulopathies
• concomitant gastric varices

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
control of hematemesis	72 hours	Success for either techniques to be able to stop the bleeding promptly and maintain that for 72 hours

Secondary Outcome Measures

Name	Time	Method
occurence of complications from the intervention	30 days	the study subjects are reveiwed in 30 days to detect any complications secondary to the endoscopic intervention.

Trial Locations

Locations (1)

Hematemesis unit, Alexandria Main University Hospital, Azarita; 🇪🇬 Alexandria, Egypt