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

NCT ID: NCT03687216

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2020-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HVPG group

HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG)

Group Type: EXPERIMENTAL

HVPG-guided therapy

Intervention Type: PROCEDURE

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 group

Routing therapy (EVL plus NSBB)

Group Type: ACTIVE_COMPARATOR

Routing Therapy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Routing Therapy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Yang

Director of Department of Gastroenterology and Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital

Chengdu, Sichuan, China

Countries

China

Facility Contacts

Li Yang

Role: primary

yangli_hx@scu.edu.cn

+8618980601276

Other Identifiers

HGT-EN

Identifier Type: -

Identifier Source: org_study_id