Bleeding Esophageal VaricesPhase 3NCT03388125
Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection
A Phase 3 study testing Injection Sclerotherapy and N-butyl-2-cyanoacrylate in people with Bleeding Esophageal Varices, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bleeding Esophageal Varices
- What is being tested?
- Injection Sclerotherapy and N-butyl-2-cyanoacrylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2016to 1 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cirrhotic patients presented with actively bleeding
Who cannot join
- other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices
Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection
Read the detailed description
Endoscopic Injection Sclerotherapy versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices
- Conditions
- Bleeding Esophageal Varices
- Being tested
- Injection Sclerotherapy, N-butyl-2-cyanoacrylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection SclerotherapyDrug
Also called 5% ethanolamine oleate
5% ethanolamine oleate group
N-butyl-2-cyanoacrylateDrug
N-butyl-2-cyanoacrylate injection group
| Study group | Role | What they receive |
|---|---|---|
| Injection Sclerotherapy | Active comparator | 5% ethano lamine oleate Receives: Drug: Injection Sclerotherapy |
| N-butyl-2-cyanoacrylate | Active comparator | N-butyl-2-cyanoacrylate injection group Receives: Drug: N-butyl-2-cyanoacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with controlled bleeding
The Number of patients with controlled bleeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Jan 2016
- Primary completion1 Aug 2017
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bleeding Esophageal VaricesStudies 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
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Mohamed Alsebaey, MD, Principal investigator, GastroenterologyMohamed Abdelraouf, MD, Study director, GastroenterologySherief Abd-Elsalam, MD, Study director, Hepatology and Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388125
- Sponsor's protocol ID
- Active bleeding
- Status last verified
- Apr 2018
- First submitted
- 23 Dec 2017
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elsebaey MA, Tawfik MA, Ezzat S, Selim A, Elashry H, Abd-Elsalam S. Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial. BMC Gastroenterol. 2019 Feb 4;19(1):23. doi: 10.1186/s12876-019-0940-1.
PubMed 30717684
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices
- ClinicalTrials.gov ID
- NCT03388125
- Acronym / sponsor ID
- Active bleeding
- Conditions
- Bleeding Esophageal Varices
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 2 Jan 2018 (actual)
- 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.
Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection
Detailed description
Endoscopic Injection Sclerotherapy versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection Sclerotherapy | Active comparator | Drug: Injection Sclerotherapy5% ethano lamine oleate |
| N-butyl-2-cyanoacrylate | Active comparator | Drug: N-butyl-2-cyanoacrylateN-butyl-2-cyanoacrylate injection group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- cirrhotic patients presented with actively bleeding
Key exclusion criteria (1 listed)
- other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC)
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 |
|---|---|---|
| Injection SclerotherapyAlso: 5% ethanolamine oleate5% ethanolamine oleate group | Drug | Injection Sclerotherapy |
| N-butyl-2-cyanoacrylateN-butyl-2-cyanoacrylate injection group | Drug | N-butyl-2-cyanoacrylate |
Primary outcome
Number of patients with controlled bleeding
Time frame: 6 months
The Number of patients with controlled bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Derived from this study: PubMed 30717684Elsebaey MA, Tawfik MA, Ezzat S, Selim A, Elashry H, Abd-Elsalam S. Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial. BMC Gastroenterol. 2019 Feb 4;19(1):23. doi: 10.1186/s12876-019-0940-1.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Alsebaey, MD principal investigator
Gastroenterology
Mohamed Abdelraouf, MD study director
Gastroenterology
Sherief Abd-Elsalam, MD study director
Hepatology and Gastroenterology
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 testing Injection Sclerotherapy and N-butyl-2-cyanoacrylate in people with Bleeding Esophageal Varices, run by Sherief Abd-Elsalam 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Apr 2018. 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?
Results are not available in the source record.
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?
Number of patients with controlled bleeding (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388125, which also lists 1 linked publication.
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 24 Apr 2018.