Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yasser Hamza, Faculty of Medicine, University of Alexandria

ClinicalTrials.gov Identifier:

NCT01131962

First received: May 26, 2010

Last updated: December 3, 2014

Last verified: December 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hematemesis Portal Hypertension	Procedure: Endoscopic control of hematemesis	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
Official Title:	Control of Acute Variceal Bleeding Using the Multi-shooter Band Ligator Compared to Injection Sclerotherapy.

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Genetic and Rare Diseases Information Center resources: Esophageal Varices

U.S. FDA Resources

Further study details as provided by Yasser Hamza, Faculty of Medicine, University of Alexandria:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.


Enrollment:	200
Study Start Date:	May 2008
Study Completion Date:	July 2012
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Active hematemesis
esophageal varices

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131962

Locations


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

Sponsors and Collaborators

Faculty of Medicine, University of Alexandria

Investigators


Principal Investigator:	Yasser Hamza, A Prof	Faculty of Medicine, University of Alexandria

More Information


Responsible Party:	Yasser Hamza, Professor of Surgery, Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier:	NCT01131962 History of Changes
Other Study ID Numbers:	egsbl1
Study First Received:	May 26, 2010
Last Updated:	December 3, 2014

Keywords provided by Yasser Hamza, Faculty of Medicine, University of Alexandria:


esophageal varices hematemesis endoscopy

Additional relevant MeSH terms:


Hematemesis Hypertension, Portal Liver Diseases Digestive System Diseases Gastrointestinal Hemorrhage Gastrointestinal Diseases	Hemorrhage Pathologic Processes Vomiting Signs and Symptoms, Digestive Signs and Symptoms

ClinicalTrials.gov processed this record on July 14, 2017

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