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

Phase 4

• Conditions: Gastroesophageal Varices; Cirrhosis
• Interventions: Other: routine therapy; Procedure: HVPG-guided therapy; Drug: Carvedilol

• Registration Number: NCT02638415
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-20
• Last Update Submitted: 2015-12-20
• Study First Posted: 2015-12-23
• Last Update Posted: 2015-12-23
• Primary Completion: 2018-06
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-HVPG group	routine therapy	routine therapy
HVPG group	HVPG-guided therapy	HVPG-guided therapy
HVPG group	Carvedilol	HVPG-guided therapy
non-HVPG group	Carvedilol	routine therapy

Primary Outcome Measures

Name	Time	Method
Mortality rate	through study completion, an average of 1 year	The investigators observe the mortality events in both groups during the study

Secondary Outcome Measures

Name	Time	Method
Rebleeding rate	through study completion, an average of 1 year	The investigators observe the rebleeding events in both groups during the study
Adverse Events	through study completion, an average of 1 year	The investigators observe any severe adverse events caused by HVPG measurement, endoscopic procedures,use of Carvedilol, surgical operations or TIPS
Total cost	through study completion, an average of 1 year	The investigators calculate the total cost of treatment of each patient during the study

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China