This was a single-center randomized controlled trial performed at the endoscopy unit of Mansoura Specialized Medical Hospital, Mansoura University, Egypt, between February 2019 and February 2022. The Study population included 52 patients with high-risk GVs classified according to the Sarin and Kumar classification
3 (link)
into GOV2 or IGV1. The inclusion criteria were as follows: age > 18 years, primary prophylaxis for high risk GVs varices (> 20 mm) on initial standard diagnostic upper endoscopy, and patients unable or unwilling to undergo alternative therapies for GVs such as transjugular intrahepatic portosystemic shunts (TIPS) or surgery. Patients were excluded if unable to give informed consent for the procedure, concurrent hepatorenal syndrome and/or multiorgan failure, previous endoscopic treatment for GVs, hepatocellular carcinoma or portal and splenic vein thrombosis, esophageal stricture, pregnant, platelets count less than 50,000 /mL and International Normalized Rate (INR) > 2.
Eligible patients were randomized in two groups using computer-generated random number sequences using excel software in concealed envelopes with block randomization design. Group A underwent EUS-guided injection of 1 ml CYA into the perforator vein and Group B underwent DEI of 1 mL CYA into the varix. Informed written consent was obtained from each participant in the study after assuring confidentiality. The study protocol and consent form were approved by the Institutional Review Board of Mansoura faculty of medicine, Mansoura University. The study was conducted in accordance with the Declaration of Helsinki and registered at ClinicalTrials.gov under the code NCT04222127.
