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

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Cirrhosis; Gastroesophageal Varices

Treatments: Other: routine therapy; Drug: Carvedilol; Procedure: HVPG-guided therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02638415

CSY-WYC02-2015

Details and patient eligibility

About

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.

Full description

The study is a randomized controlled trial of Zelen-design. Patients randomly enter two treatment groups: 1) the HVPG group and 2) the non-HVPG group. Treatment allocation is by block randomization with an equal number for both groups. The results are concealed in opaque envelopes.After randomization, patients will have a second chance to decide if they want to stay in the current group.Patients can switch to another group according to their will. If they are in the HVPG group，they will receive HVPG measurement before treatment. If they are in the non-HVPG group, they start treatment without HVPG measurement and receive endoscopic treatment plus Carvedilol.The mortality rate and rebleeding rate will be analyzed.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with cirrhosis diagnosed by histology, radiological evidence of cirrhosis, and endoscopic evidence of varices;
• Patients with a previous history of variceal hemorrhage;
• Patients admitted to Zhongshan Hospital and other 6 tertiary centers in Shanghai from Dec 1, 2015 to Sep 31,2018

Exclusion criteria

• Patients already taken secondary prophylactic treatment including endoscopic, pharmacological, surgical and interventional therapies;
• Patients with severe systemic diseases such as chronic heart failure or chronic renal failure that will have impact on survival;
• Patients in pregnancy and lactation;
• Patients already diagnosed with hepatic cellular carcinoma or other malignant tumors;
• Patients with contraindication to treatment of endoscopy, surgery and TIPS: severe coagulation defects, allergic to contrast medium used in TIPS, hepatic encephalopathy, spontaneous bacterial peritonitis;
• Patients with conditions that will influence the accuracy of HVPG measurement: Cavernous transformation of portal vein, diffused portal vein thrombosis, severe shunt;
• Patients refuse to give consent to the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

HVPG group

Experimental group

Description:

HVPG-guided therapy

Treatment:

Drug: Carvedilol

Procedure: HVPG-guided therapy

non-HVPG group

Other group

Description:

routine therapy

Treatment:

Drug: Carvedilol

Other: routine therapy