- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01131962
Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope
December 3, 2014 updated by: Yasser Hamza, University of Alexandria
Control of Acute Variceal Bleeding Using the Multi-shooter Band Ligator Compared to Injection Sclerotherapy.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The use of band ligation for endoscopy during the attack of hematemesis is a novel practice as opposed to injection sclerotherapy.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Alexandria, Egypt
- Hematemesis unit, Alexandria Main University Hospital, Azarita
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Active hematemesis
- esophageal varices
Exclusion Criteria:
- Hemodynamic unstability
- Hepatic coma or precoma
- Tense ascitis
- Coagulopathies
- concomitant gastric varices
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: band ligation group
this group will have immediate control of the hematemesis by endoscopic band ligation.
|
Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy
Other Names:
|
ACTIVE_COMPARATOR: sclerotherapy group
This group will have immediate control of hematemesis by endoscopic sclerotherapy
|
Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yasser Hamza, A Prof, University of Alexandria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
September 1, 2011
Study Completion (ACTUAL)
July 1, 2012
Study Registration Dates
First Submitted
May 26, 2010
First Submitted That Met QC Criteria
May 26, 2010
First Posted (ESTIMATE)
May 27, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
December 4, 2014
Last Update Submitted That Met QC Criteria
December 3, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- egsbl1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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