Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Faculty of Medicine, University of Alexandria.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier:
NCT01131962
First received: May 26, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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.


Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: September 2010 (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
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

Contacts
Contact: Yasser Hamza, A Prof 0020122375287 hamzay3@hotmail.com

Locations
Egypt
Hematemesis unit, Alexandria Main University Hospital, Azarita Recruiting
Alexandria, Egypt
Contact: Hamza       Hamzay3@hotmail.com   
Principal Investigator: Yasser Hamza, A Prof         
Sponsors and Collaborators
Faculty of Medicine, University of Alexandria
Investigators
Principal Investigator: Yasser Hamza, A Prof Faculty of Medicine, University of Alexandria
  More Information

No publications provided

Responsible Party: Yasser Hamza, Faculty of Medicine, University of Alexandria, Egypt
ClinicalTrials.gov Identifier: NCT01131962     History of Changes
Other Study ID Numbers: egsbl1
Study First Received: May 26, 2010
Last Updated: May 26, 2010
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:
Hematemesis
Hypertension
Hypertension, Portal
Gastrointestinal Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 01, 2014