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

December 20, 2015 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

The Effect of HVPG-Guided Individualized Therapy in Patients With Cirrhosis Related Esophagogastric Variceal Hemorrhage For Secondary Prophylaxis:A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Shanghai Zhongshan Hospital
        • Contact:
        • Principal Investigator:
          • Shiyao Chen, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HVPG group
HVPG-guided therapy
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.

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.
Other: non-HVPG group
routine therapy
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.
Other: routine therapy
Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: through study completion, an average of 1 year
The investigators observe the mortality events in both groups during the study
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding rate
Time Frame: through study completion, an average of 1 year
The investigators observe the rebleeding events in both groups during the study
through study completion, an average of 1 year
Adverse Events
Time Frame: 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
through study completion, an average of 1 year
Total cost
Time Frame: through study completion, an average of 1 year
The investigators calculate the total cost of treatment of each patient during the study
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Eastern Hepatobiliary Surgery Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ShuGuang Hospital
Shanghai Pudong New Area Gongli Hospital

Investigators

  • Principal Investigator: Shiyao Chen, Professor, Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 20, 2015

First Posted (Estimate)

December 23, 2015

Study Record Updates

Last Update Posted (Estimate)

December 23, 2015

Last Update Submitted That Met QC Criteria

December 20, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSY-WYC02-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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