Esophageal VaricesNCT04602663
Optimal Time for Follow up After Variceal Band Ligation
A study testing Esophageal Variceal Band ligation in people with Esophageal Varices, run by Tanta University at 1 site in Egypt.
Trial summary
Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Varices
- What is being tested?
- Esophageal Variceal Band ligation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 31 Dec 2021
- Phase
- Interventional
- 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 portal hypertension with medium or large sized or risky varices or variceal bleeding
Who cannot join
- non-cirrhotic portal hypertension
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
About this study
Official title: Optimal Time for Follow up After Variceal Band Ligation in Cirrhotic Patients: a Randomized Trial
Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined
Read the detailed description
Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined. So, we designed this trial to answer this question.
- Conditions
- Esophageal Varices
- Being tested
- Esophageal Variceal Band ligation
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal Variceal Band ligationDevice
Also called Band ligation
Band ligation of OV
| Study group | Role | What they receive |
|---|---|---|
| follow up every week | Experimental | Variceal Band ligation every week. Receives: Device: Esophageal Variceal Band ligation |
| follow up every 2 weeks | Experimental | Variceal Band ligation every 2 weeks Receives: Device: Esophageal Variceal Band ligation |
| follow up every 3 weeks | Experimental | Variceal Band ligation every 3 weeks Receives: Device: Esophageal Variceal Band ligation |
| follow up every 4 weeks | Experimental | Variceal Band ligation every 4 weeks Receives: Device: Esophageal Variceal Band ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with eradicated varices
The total number of patients with eradicated varices
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 posted26 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Mohamed Alboraie, MD, Principal investigator, Al-Azhar UniversityAhmed Maher, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602663
- Sponsor's protocol ID
- VARICES
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Time for Follow up After Variceal Band Ligation in Cirrhotic Patients: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04602663
- Acronym / sponsor ID
- VARICES
- Conditions
- Esophageal Varices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Oct 2020 (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.
Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined
Detailed description
Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined. So, we designed this trial to answer this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| follow up every week | Experimental | Device: Esophageal Variceal Band ligationVariceal Band ligation every week. |
| follow up every 2 weeks | Experimental | Device: Esophageal Variceal Band ligationVariceal Band ligation every 2 weeks |
| follow up every 3 weeks | Experimental | Device: Esophageal Variceal Band ligationVariceal Band ligation every 3 weeks |
| follow up every 4 weeks | Experimental | Device: Esophageal Variceal Band ligationVariceal Band ligation every 4 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- cirrhotic portal hypertension with medium or large sized or risky varices or variceal bleeding
Key exclusion criteria (1 listed)
- non-cirrhotic portal hypertension
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 |
|---|---|---|
| Esophageal Variceal Band ligationAlso: Band ligationBand ligation of OV | Device | follow up every 2 weeks, follow up every 3 weeks, follow up every 4 weeks, follow up every week |
Primary outcome
Number of patients with eradicated varices
Time frame: 1 year
The total number of patients with eradicated varices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: No
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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 Alboraie, MD principal investigator
Al-Azhar University
Ahmed Maher, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal Variceal Band ligation in people with Esophageal Varices, run by Tanta University 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 26 Oct 2020. 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.
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 Abd-Elsalam, MD (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with eradicated varices (time frame: 1 year). 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 26 Oct 2020.