Comparing two techniques for treating esophageal varices
Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. A Randomized Controlled Trial.
This study is testing two different techniques for treating esophageal varices to see which one works better at preventing them from coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbyea) |
| Trial ID | NCT06881082 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different endoscopic band ligation techniques—cross-section and stepladder—for the prophylaxis of esophageal varices. Participants will undergo a thorough clinical assessment, including upper endoscopy to determine the presence and severity of varices. They will be randomly assigned to receive one of the two band ligation techniques every two to four weeks until the varices are eradicated. Follow-up endoscopies will be conducted to monitor for recurrence of varices over a six-month period.
Who should consider this trial
Good fit: Ideal candidates for this study are cirrhotic patients over 18 years old with medium to large-sized esophageal varices.
Not a fit: Patients with a history of variceal bleeding, advanced cardiovascular or respiratory diseases, or those with uncontrolled diabetes or renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and prevention of esophageal varices, potentially leading to better patient outcomes and survival rates.
How similar studies have performed: While there have been studies on band ligation techniques, this specific comparison of cross-section versus stepladder techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta, Gharbyea
- Tanta University Hospitals — Tanta, Gharbyea, Egypt (Recruiting)
Study contacts
- Principal investigator: Nabila A Elgazzar, MD — Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
- Study coordinator: Rania M Elkafoury, MD
- Email: rania.elkafoury@med.tanta.edu.eg
- Phone: +201004672358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.