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Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

NCT ID: NCT01131962

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-07-31

Brief Summary

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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

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

Conditions

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Hematemesis Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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band ligation group

this group will have immediate control of the hematemesis by endoscopic band ligation.

Group Type ACTIVE_COMPARATOR

Endoscopic control of hematemesis

Intervention Type PROCEDURE

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

sclerotherapy group

This group will have immediate control of hematemesis by endoscopic sclerotherapy

Group Type ACTIVE_COMPARATOR

Endoscopic control of hematemesis

Intervention Type PROCEDURE

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

Interventions

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Endoscopic control of hematemesis

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

Intervention Type PROCEDURE

Other Intervention Names

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Six shooter band ligator Ehanolamine oleate sclerosant material

Eligibility Criteria

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Inclusion Criteria

* Active hematemesis
* esophageal varices

Exclusion Criteria

* Hemodynamic unstability
* Hepatic coma or precoma
* Tense ascitis
* Coagulopathies
* concomitant gastric varices
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Yasser Hamza

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasser Hamza, A Prof

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

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Hematemesis unit, Alexandria Main University Hospital, Azarita

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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egsbl1

Identifier Type: -

Identifier Source: org_study_id