Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

December 3, 2014 updated by: Yasser Hamza, University of Alexandria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Hematemesis unit, Alexandria Main University Hospital, Azarita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Active hematemesis
  • esophageal varices

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: band ligation group
this group will have immediate control of the hematemesis by endoscopic band ligation.
Procedure: Endoscopic control of hematemesis
Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy
Other Names:
  • Six shooter band ligator
  • Ehanolamine oleate sclerosant material
ACTIVE_COMPARATOR: sclerotherapy group
This group will have immediate control of hematemesis by endoscopic sclerotherapy
Procedure: Endoscopic control of hematemesis
Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy
Other Names:
  • Six shooter band ligator
  • Ehanolamine oleate sclerosant material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
control of hematemesis
Time Frame: 72 hours
Success for either techniques to be able to stop the bleeding promptly and maintain that for 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurence of complications from the intervention
Time Frame: 30 days
the study subjects are reveiwed in 30 days to detect any complications secondary to the endoscopic intervention.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Investigators

  • Principal Investigator: Yasser Hamza, A Prof, University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (ESTIMATE)

May 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • egsbl1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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