NCT03687216

HVPG-Guided Therapy Versus EVL Plus NSBB in Second Prophylaxis of Esophageal Variceal Bleeding

A Single-center Randomized Controlled Study of Secondary Prophylaxis of Cirrhosis Related Esophagogastric Variceal Hemorrhage Treated With HVPG-guided Therapy or Standard Esophageal Variceal Ligation Plus Beta-blocker

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A single-center randomized controlled study comparing endoscopic or interventional therapy guided by the hepatic venous pressure gradient (HVPG) , to standard endosopic variceal ligation plus nonselective beta-blocker therapy (NSBB) in patients with esophageal varices due to liver cirrhosis with a history of esophageal variceal hemorrhage.Primary study outcome of the study is variceal rebleeding episodes occurring within the first years after interventions. Second study outcomes of the study are hepatic encephalopathy occurrence, mortality occurrence, liver transplantation or other cirrhosis-related complications.

Conditions

• Esophageal Varices in Cirrhosis of the Liver

Interventions

Type	Name	Description
PROCEDURE	HVPG-guided therapy	The baseline HVPG measurement is performed. According to the result, patients with an HVPG over 20 mmHg will be receive transjugular intrahepatic portocaval shunt (TIPS) . Patients with an HVPG below 20 mmHg will be treated by endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol until treatment fails.
PROCEDURE	Routing Therapy	Without HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2018-09-27
• Last updated: 2019-03-13

Locations

1 site across 1 country: China