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

Primary Purpose

Gastroesophageal Varices, Cirrhosis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
HVPG-guided therapy
routine therapy
Carvedilol
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastroesophageal Varices focused on measuring HVPG

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HVPG group

non-HVPG group

Arm Description

HVPG-guided therapy

routine therapy

Outcomes

Primary Outcome Measures

Mortality rate
The investigators observe the mortality events in both groups during the study

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2015
Last Updated
December 20, 2015
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Pudong New Area Gongli Hospital, Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02638415
Brief Title
The Effect of Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy in Cirrhotic Patients With Esophagogastric Varices
Official Title
The Effect of HVPG-Guided Individualized Therapy in Patients With Cirrhosis Related Esophagogastric Variceal Hemorrhage For Secondary Prophylaxis:A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, ShuGuang Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Pudong New Area Gongli Hospital, Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Varices, Cirrhosis
Keywords
HVPG

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HVPG group
Arm Type
Experimental
Arm Description
HVPG-guided therapy
Arm Title
non-HVPG group
Arm Type
Other
Arm Description
routine therapy
Intervention Type
Procedure
Intervention Name(s)
HVPG-guided therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
routine therapy
Intervention Description
Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality rate
Description
The investigators observe the mortality events in both groups during the study
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Rebleeding rate
Description
The investigators observe the rebleeding events in both groups during the study
Time Frame
through study completion, an average of 1 year
Title
Adverse Events
Description
The investigators observe any severe adverse events caused by HVPG measurement, endoscopic procedures,use of Carvedilol, surgical operations or TIPS
Time Frame
through study completion, an average of 1 year
Title
Total cost
Description
The investigators calculate the total cost of treatment of each patient during the study
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyao Chen, Professor
Phone
86-13601767310
Email
chen.shiyao@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, Professor
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yichao Wei, Doctor
Phone
86-13918891342
Email
08301010253@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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