Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Faculty of Medicine, University of Alexandria:

Primary Outcome Measures:
  • control of hematemesis [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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)
Genders Eligible for Study:   Both
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
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016