Combined and Simultaneous Approach for the Treatment of High-risk Gastric Varices Using B-RTO and EVO — BeRTO  

Gastric Varix Clinical Trial

Official title: A Pilot Study Evaluating Efficacy and Safety of Combined and Simultaneous Balloon-occluded Retrograde Transvenous and Endoscopic Obliteration of High-risk Gastric Varices

Status Not yet recruiting

Clinical Trial Summary

The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with balloon occluded-retrograde transvenous obliteration (B-RTO) for the treatment of high-risk gastric varices

Clinical Trial Description

Although less frequent than esophageal varices, gastric varices constitute a severe and potentially life threatening complication of portal hypertension. Various methods have been described to treat gastric varices, including endoscopic and interventional radiology techniques. Endoscopic variceal obliteration (EVO) is currently considered as standard of care for the treatment of gastric varices in most centers. However, this technique is associated with significant rebleeding rates and incomplete obliteration is observed in about 50% of patients. Alternatively, few centers also use an interventional radiology technique, called balloon-occluded retrograde transvenous obliteration (B-RTO) to treat gastric varices, which has been shown to be associated with less recurrence of gastric varices and high rates of eradication of about 90%. Both techniques have their inherent weaknesses, such as frequent incomplete eradication of varices and thromboembolic events for EVO, while data suggest that B-RTO may aggravate esophageal varices.

The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with (modified) B-RTO. Stopping the outflow of gastric varices by endovascular balloon occlusion may allow better endoscopic visualization, blood stagnation and thus eradication of varices, while preventing thromboembolic events. Furthermore, during study follow-up, the eradication rates and recurrence of varices, short-term and long term complications, effects of the procedure on portal pressures/hemodynamics and liver function will be evaluated. ;

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric Varices Bleeding
• Gastric Varix
• Varicose Veins

• NCT number: NCT03853720
• Study type: Interventional
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Alban Denys, MD
• Phone: 0041213149768
• Email: alban.denys@chuv.ch
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Completion date: April 2023