The Effect of Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy in Cirrhotic Patients With Esophagogastric Varices

Summary

The purpose of the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.

Conditions

• Gastroesophageal Varices
• Cirrhosis

Interventions

PROCEDURE

HVPG-guided therapy

Patients with an HVPG over 20mmHg will be suggested to receive transjugular intrahepatic portocaval shunt (TIPS) or surgical shunt operation. Patients with an HVPG between 16 and 20mmHg can choose either endoscopic treatment or TIPS according their willingness and indication. Patients with an HVPG below 16mmHg will be treated by endoscopy plus Carvedilol, until endoscopic treatment fails.

OTHER

routine therapy

Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.

DRUG

Carvedilol

Patients in HVPG group with HVPG below 16mmHg and all patients in non-HVPG group will take Carvedilol 12.5mg/d if they have no contraindications.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• ShuGuang Hospital

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Shanghai Pudong New Area Gongli Hospital

  collaborator OTHER

• Eastern Hepatobiliary Surgery Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  lead OTHER

Principal Investigators

• Shiyao Chen, Professor · Shanghai Zhongshan Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2018-06-30

Completion

2018-09-30

Countries

• China

Study Locations