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Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131962
First Posted: May 27, 2010
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yasser Hamza, Faculty of Medicine, University of Alexandria
  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 (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:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 26, 2010
First Posted: May 27, 2010
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Yasser Hamza, Faculty of Medicine, University of Alexandria:
esophageal varices
hematemesis
endoscopy

Additional relevant MeSH terms:
Hypertension, Portal
Hematemesis
Liver Diseases
Digestive System Diseases
Gastrointestinal Hemorrhage
Gastrointestinal Diseases
Hemorrhage
Pathologic Processes
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms