Esophageal VaricesNCT06881082
Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices
A study testing endoscopic band ligation with cross-section technique and Endoscopic band ligation using stepladder technique in people with Esophageal Varices, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this randomized controlled trial is to evaluate the cross-section band ligation technique versus the stepladder band ligation technique in esophageal varices prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Varices
- What is being tested?
- endoscopic band ligation with cross-section technique and Endoscopic band ligation using stepladder technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged >18 years.
- Cirrhotic patients.
- Endoscopic evidence of medium/large-sized esophageal varices.
Who cannot join
- History of variceal bleeding or previous primary prevention of varices.
- Portal vein thrombosis or previous porto-systemic shunts as TIPS.
- Patients on drugs affecting portal pressure (beta blockers, nitrates).
- Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, and severe bradycardia.
- Patients with severe respiratory diseases (COPD, bronchial asthma).
- Uncontrolled diabetes mellitus.
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- Renal impairment.
- Hepatocellular carcinoma.
- Allergy to carvedilol.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbyea, 31516
Dina H Ziada, MD, 00201117109990, dina.ziada@med.tanta.edu.eg
dr_ranon3000@yahoo.com
About this study
Official title: Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. A Randomized Controlled Trial.
The goal of this randomized controlled trial is to evaluate the cross-section band ligation technique versus the stepladder band ligation technique in esophageal varices prophylaxis.
Researchers will compare cross-section and step ladder band ligation techniques for esophageal varices prophylaxis regarding efficacy, side effects, variceal recurrence, and survival.
Participants will undergo history-taking, clinical examination, laboratory investigations, and upper endoscopy. Index upper endoscopy will be performed to evaluate the presence, size, and grade of esophageal varices. Patients will be randomly assigned to endoscopic band ligation (EBL) either by cross-section or stepladder techniques every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3-6 months to check for variceal recurrence. For a period of 6 months, all patients in the treatment groups will be followed up every 3 months with clinic visits, including laboratory testing, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment.
- Conditions
- Esophageal Varices
- Being tested
- endoscopic band ligation with cross-section technique, Endoscopic band ligation using stepladder technique
- Keywords
- Band ligation, esophageal varices prophylaxis
- 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.
endoscopic band ligation with cross-section techniqueProcedure or surgery
Endoscopic band ligation (EBL) of medium/large-sized esophageal varices using the cross-section banding technique. EBL will be repeated every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3- 6 months to check for variceal recurrence, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment.
Endoscopic band ligation using stepladder techniqueProcedure or surgery
Endoscopic band ligation (EBL) of medium/large-sized esophageal varices using the stepladder banding technique. EBL will be repeated every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3- 6 months to check for variceal recurrence, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment
| Study group | Role | What they receive |
|---|---|---|
| cross-section band ligation | Experimental | 160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the cross-section band ligation technique. Receives: Procedure: endoscopic band ligation with cross-section technique |
| stepladder band ligation | Active comparator | 160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the step ladder band ligation technique. Receives: Procedure: Endoscopic band ligation using stepladder technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vriceal bleeding rate at 6 weeks follow up
-The occurrence of first variceal bleeding (early bleeding within 3 - 10 days after band ligation and late bleeding after that) will be evaluated and compared across the studied groups.
Measured: through study completion, an average of 1 year
Mortality rate at 6 weeks follow up
Bleeding-related mortality rate and overall mortality rate at 6 weeks will be assessed and compared across the studied groups.
Measured: through study completion, an average of 1 year
Banding side effects at 6 weeks follow up
Side effects of banding (e.g. post banding ulcers, portal hypertensive gastropathy, esophageal strictures and perforation) at 6 weeks will be evaluated and compared across the studied groups.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Variceal obliteration rate at 6 months follow up
Obliteration of esophageal varices rate at 6 months will be evaluated and compared across the studied groups.
Measured: through study completion, an average of 1 year
Variceal recurrence rate at 6 months follow up
Recurrence of esophageal varices rate at 6 months after obliteration will be evaluated and compared across the studied groups.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Dec 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
- Investigators
- Nabila A Elgazzar, MD, Principal investigator, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881082
- Sponsor's protocol ID
- 36264PR978/12/24
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06881082
- Acronym / sponsor ID
- 36264PR978/12/24
- Conditions
- Esophageal Varices
- Keywords
- Band ligation, esophageal varices prophylaxis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Mar 2025 (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.
The goal of this randomized controlled trial is to evaluate the cross-section band ligation technique versus the stepladder band ligation technique in esophageal varices prophylaxis.
Researchers will compare cross-section and step ladder band ligation techniques for esophageal varices prophylaxis regarding efficacy, side effects, variceal recurrence, and survival.
Participants will undergo history-taking, clinical examination, laboratory investigations, and upper endoscopy. Index upper endoscopy will be performed to evaluate the presence, size, and grade of esophageal varices. Patients will be randomly assigned to endoscopic band ligation (EBL) either by cross-section or stepladder techniques every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3-6 months to check for variceal recurrence. For a period of 6 months, all patients in the treatment groups will be followed up every 3 months with clinic visits, including laboratory testing, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cross-section band ligation | Experimental | Procedure: endoscopic band ligation with cross-section technique160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the cross-section band ligation technique. |
| stepladder band ligation | Active comparator | Procedure: Endoscopic band ligation using stepladder technique160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the step ladder band ligation technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged >18 years.
- Cirrhotic patients.
- Endoscopic evidence of medium/large-sized esophageal varices.
Key exclusion criteria (10 listed)
- History of variceal bleeding or previous primary prevention of varices.
- Portal vein thrombosis or previous porto-systemic shunts as TIPS.
- Patients on drugs affecting portal pressure (beta blockers, nitrates).
- Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, and severe bradycardia.
- Patients with severe respiratory diseases (COPD, bronchial asthma).
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 band ligation with cross-section techniqueEndoscopic band ligation (EBL) of medium/large-sized esophageal varices using the cross-section banding technique. EBL will be repeated every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3- 6 months to check for variceal recurrence, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment. | Procedure or surgery | cross-section band ligation |
| Endoscopic band ligation using stepladder techniqueEndoscopic band ligation (EBL) of medium/large-sized esophageal varices using the stepladder banding technique. EBL will be repeated every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3- 6 months to check for variceal recurrence, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment | Procedure or surgery | stepladder band ligation |
Primary outcome
Vriceal bleeding rate at 6 weeks follow up
Time frame: through study completion, an average of 1 year
-The occurrence of first variceal bleeding (early bleeding within 3 - 10 days after band ligation and late bleeding after that) will be evaluated and compared across the studied groups.
Mortality rate at 6 weeks follow up
Time frame: through study completion, an average of 1 year
Bleeding-related mortality rate and overall mortality rate at 6 weeks will be assessed and compared across the studied groups.
Banding side effects at 6 weeks follow up
Time frame: through study completion, an average of 1 year
Side effects of banding (e.g. post banding ulcers, portal hypertensive gastropathy, esophageal strictures and perforation) at 6 weeks will be evaluated and compared across the studied groups.
2 secondary outcomes
Variceal obliteration rate at 6 months follow up
Time frame: through study completion, an average of 1 year
Variceal recurrence rate at 6 months follow up
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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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.
Nabila A Elgazzar, MD principal investigator
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta 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 endoscopic band ligation with cross-section technique and Endoscopic band ligation using stepladder technique 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania M Elkafoury, MD (+201004672358, rania.elkafoury@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vriceal bleeding rate at 6 weeks follow up (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 18 Mar 2025.