HematemesisPhase 3NCT01131962
Comparing Two Methods to Stop Vomiting of Blood Using the Endoscope
A Phase 3 study of Hematemesis and Portal Hypertension, run by University of Alexandria at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematemesis, Portal Hypertension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- May 2008to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active hematemesis
- esophageal varices
Who cannot join
- Hemodynamic unstability
- Hepatic coma or precoma
- Tense ascitis
- Coagulopathies
- concomitant gastric varices
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Hematemesis unit, Alexandria Main University Hospital, Azarita
Alexandria
About this study
Official title: 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.
Read the detailed description
The use of band ligation for endoscopy during the attack of hematemesis is a novel practice as opposed to injection sclerotherapy.
- Conditions
- Hematemesis, Portal Hypertension
- Being tested
- Endoscopic control of hematemesis
- Keywords
- esophageal varices, hematemesis, endoscopy
- Medical subject headings
- Hematemesis, Hypertension, Portal, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic control of hematemesisProcedure or surgery
Also called Six shooter band ligator, Ehanolamine oleate sclerosant material
Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy
| Study group | Role | What they receive |
|---|---|---|
| band ligation group | Active comparator | this group will have immediate control of the hematemesis by endoscopic band ligation. Receives: Procedure: Endoscopic control of hematemesis |
| sclerotherapy group | Active comparator | This group will have immediate control of hematemesis by endoscopic sclerotherapy Receives: Procedure: Endoscopic control of hematemesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
control of hematemesis
Success for either techniques to be able to stop the bleeding promptly and maintain that for 72 hours
Measured: 72 hours
Secondary outcomes (1)
occurence of complications from the intervention
the study subjects are reveiwed in 30 days to detect any complications secondary to the endoscopic intervention.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMay 2008
- Primary completionSep 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematemesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Hamza, University of Alexandria
- Investigators
- Yasser Hamza, A Prof, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131962
- Sponsor's protocol ID
- egsbl1
- Status last verified
- Dec 2014
- First submitted
- 26 May 2010
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Acute Variceal Bleeding Using the Multi-shooter Band Ligator Compared to Injection Sclerotherapy.
- ClinicalTrials.gov ID
- NCT01131962
- Acronym / sponsor ID
- egsbl1
- Conditions
- Hematemesis, Portal Hypertension
- Keywords
- esophageal varices, hematemesis, endoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The use of band ligation for endoscopy during the attack of hematemesis is a novel practice as opposed to injection sclerotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| band ligation group | Active comparator | Procedure: Endoscopic control of hematemesisthis group will have immediate control of the hematemesis by endoscopic band ligation. |
| sclerotherapy group | Active comparator | Procedure: Endoscopic control of hematemesisThis group will have immediate control of hematemesis by endoscopic sclerotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active hematemesis
- esophageal varices
Key exclusion criteria (5 listed)
- Hemodynamic unstability
- Hepatic coma or precoma
- Tense ascitis
- Coagulopathies
- concomitant gastric varices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic control of hematemesisAlso: Six shooter band ligator, Ehanolamine oleate sclerosant materialEndoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy | Procedure or surgery | band ligation group, sclerotherapy group |
Primary outcome
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
1 secondary outcome
occurence of complications from the intervention
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
Related trials for Hematemesis
Recruiting
A Study to Evaluate the Performance of a Wireless Optical Sensor Capsule in Detection of UGIB
Melena, Gastrointestinal Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Hamza, A Prof principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hematemesis and Portal Hypertension, run by University of Alexandria at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
control of hematemesis (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.