Clinical trial NCT06881082: Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices
Official title: Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Varices
Keywords: Band ligation
esophageal varices prophylaxis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* Aged \>18 years.
* Cirrhotic patients.
* Endoscopic evidence of medium/large-sized esophageal varices.

Exclusion Criteria:

* 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.
* Renal impairment.
* Hepatocellular carcinoma.
* Allergy to carvedilol.
* Pregnancy or lactation.

Primary outcomes:
measure: Vriceal bleeding rate at 6 weeks follow up
timeFrame: through study completion, an average of 1 year
measure: Mortality rate at 6 weeks follow up
timeFrame: through study completion, an average of 1 year
measure: Banding side effects at 6 weeks follow up
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Variceal obliteration rate at 6 months follow up
timeFrame: through study completion, an average of 1 year
measure: Variceal recurrence rate at 6 months follow up
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbyea
Study officials:
affiliation: Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
name: Nabila A Elgazzar, MD
role: PRINCIPAL_INVESTIGATOR
References: