Gastroesophageal VaricesPhase 3NCT02646202
Scleroligation for Eradication of Gastroesophageal Varices.
A Phase 3 study testing Sclerotherapy, Band ligation and Scleroligation in people with Gastroesophageal Varices, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation are very effective in controlling acute esophageal varices bleeding and preventing rebleeding. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Varices
- What is being tested?
- Sclerotherapy, Band ligation and Scleroligation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Dec 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding.
Who cannot join
- Patients were excluded if they had malignancy of any origin.
- Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases.
- Other potential causes of GIT bleeding.
- Patients with previous endoscopic or surgical intervention for varices were also excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tropical medicine dept.-Tanta university hospital
Tanta
Sherief Abd-Elsalam, Sherif_tropical@yahoo.com
About this study
Official title: Scleroligation is a Safe and Effective New Technique for Eradication of Gastroesophageal Varices.
Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation are very effective in controlling acute esophageal varices bleeding and preventing rebleeding.
Read the detailed description
Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.
- Conditions
- Gastroesophageal Varices
- Being tested
- Sclerotherapy, Band ligation, Scleroligation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SclerotherapyProcedure or surgery
Injection of varices
Band ligationProcedure or surgery
endoscopic banding of varices
ScleroligationProcedure or surgery
intra variceal endoscopic sclerotherapy combined with band ligation.
| Study group | Role | What they receive |
|---|---|---|
| Sclerotherapy group | Active comparator | thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%. Receives: Procedure: Sclerotherapy |
| Endoscopic band ligation group | Active comparator | thirty patients treated by endoscopic banding using the Euro-Ligator system. Receives: Procedure: Band ligation |
| Sclero-ligation (SL) group | Experimental | thirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation. Receives: Procedure: Scleroligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions to complete variceal obliteration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (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 Gastroesophageal 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Ferial El-kalla, Professor, Principal investigator, Head of endoscopy unit - Tropical medicine department- TantaMohamed Elhendawy, Consultant, Principal investigator, liver diseases dept.- Tanta university hospitalLoai Mansour, Consultant, Study director, liver diseases dept.-Tanta university hospitalAbdelrahman kobtan, Consultant, Study chair, liver diseases dept.-Tanta university hospitalRehab Badawy, Consultant, Study chair, liver diseases dept.-Tanta university hospitalHanan Elbasat, Professor, Study chair, liver diseases dept.-Tanta university hospitalSherief Abd-Elsalam, Consultant, Study chair, Liver diseases and gastroenterology dept.-Tanta university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646202
- Sponsor's protocol ID
- Scleroligation
- Status last verified
- Dec 2017
- First submitted
- 1 Jan 2016
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mansour L, El-Kalla F, El-Bassat H, Abd-Elsalam S, El-Bedewy M, Kobtan A, Badawi R, Elhendawy M. Randomized controlled trial of scleroligation versus band ligation alone for eradication of gastroesophageal varices. Gastrointest Endosc. 2017 Aug;86(2):307-315. doi: 10.1016/j.gie.2016.12.026. Epub 2017 Jan 9.
PubMed 28082116
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleroligation is a Safe and Effective New Technique for Eradication of Gastroesophageal Varices.
- ClinicalTrials.gov ID
- NCT02646202
- Acronym / sponsor ID
- Scleroligation
- Conditions
- Gastroesophageal Varices
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Jan 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Jan 2016 (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.
Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation are very effective in controlling acute esophageal varices bleeding and preventing rebleeding.
Detailed description
Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sclerotherapy group | Active comparator | Procedure: Sclerotherapythirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%. |
| Endoscopic band ligation group | Active comparator | Procedure: Band ligationthirty patients treated by endoscopic banding using the Euro-Ligator system. |
| Sclero-ligation (SL) group | Experimental | Procedure: Scleroligationthirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding.
Key exclusion criteria (4 listed)
- Patients were excluded if they had malignancy of any origin.
- Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases.
- Other potential causes of GIT bleeding.
- Patients with previous endoscopic or surgical intervention for varices were also excluded.
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 |
|---|---|---|
| SclerotherapyInjection of varices | Procedure or surgery | Sclerotherapy group |
| Band ligationendoscopic banding of varices | Procedure or surgery | Endoscopic band ligation group |
| Scleroligationintra variceal endoscopic sclerotherapy combined with band ligation. | Procedure or surgery | Sclero-ligation (SL) group |
Primary outcome
Number of sessions to complete variceal obliteration
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Derived from this study: PubMed 28082116Mansour L, El-Kalla F, El-Bassat H, Abd-Elsalam S, El-Bedewy M, Kobtan A, Badawi R, Elhendawy M. Randomized controlled trial of scleroligation versus band ligation alone for eradication of gastroesophageal varices. Gastrointest Endosc. 2017 Aug;86(2):307-315. doi: 10.1016/j.gie.2016.12.026. Epub 2017 Jan 9.
- Individual participant dataSharing planned: Undecided
Related trials for Gastroesophageal Varices
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Not yet recruiting
Mesenteric Vein Access for OPVT-Related Recurrent Variceal Bleeding: An Ambispective Cohort
Occlusive Portal Vein Thrombosis (OPVT), Cavernous Transformation of Portal Vein
Recruiting
Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices Bleeding
Not yet recruiting
Underdilated VCX-TIPS Versus EVL Plus NSBB for Secondary Prophylaxis of Variceal Bleeding in Cirrhosis
Liver Cirrhosis, Portal Hypertension
Not yet recruitingObservational study
Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding
Portal Hypertension, Gastroesophageal Varices Hemorrhage
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.
Ferial El-kalla, Professor principal investigator
Head of endoscopy unit - Tropical medicine department- Tanta
Mohamed Elhendawy, Consultant principal investigator
liver diseases dept.- Tanta university hospital
Loai Mansour, Consultant study director
liver diseases dept.-Tanta university hospital
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 Sclerotherapy, Band ligation and Scleroligation in people with Gastroesophageal 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 4 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 27 Dec 2017. 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?
Contact Sherief M. Abd-Elsalam, Consultant (00201095159522, sherif_tropical@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sessions to complete variceal obliteration (time frame: 1 year). 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 NCT02646202, 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 27 Dec 2017.