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

Esophageal Varices in Cirrhosis of the Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03687216
• Other study ID #: HGT-EN
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Liver cirrhosis diagnosed by clinical examination, imaging or biopsy;

• A previous history of variceal hemorrhage;

• Written informed consent.

Exclusion Criteria:

• Previous history of secondary prophylactic treatment;

• Contraindications to treatment of endoscopy, surgery and TIPS

• Severe cardiac, pulmonary or renal dysfunction;

• Lactating or pregnant;

• Malignancies;

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices in Cirrhosis of the Liver
• Fibrosis
• Liver Cirrhosis

Intervention

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.
• Routing Therapy
Without HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variceal rebleeding rate	The incidence of clinically significant gastrointestinal variceal bleeding	One year of follow-up
Secondary	Hepatic encephalopathy: The incidence of hepatic encephalopathy	The incidence of hepatic encephalopathy	One year of follow-up
Secondary	Ascites: The incidence of ascites detected by ultrasound	The incidence of ascites detected by ultrasound	One year of follow-up
Secondary	Cirrhotic complications	portal vein thrombosis, liver dysfunction, hepatorenal syndrome et al.	One year of follow-up
Secondary	Liver transplant-free survivial	Time from the procedure to the date of lost-to-follow-up or death or liver transplant	One year of follow-up