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HVPG-Guided Therapy Versus EVL Plus NSBB in Second Prophylaxis of Esophageal Variceal Bleeding

Primary Purpose

Esophageal Varices in Cirrhosis of the Liver

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HVPG-guided therapy
Routing Therapy
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Varices in Cirrhosis of the Liver

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Liver cirrhosis diagnosed by clinical examination, imaging or biopsy;
  • A previous history of variceal hemorrhage;
  • Written informed consent.

Exclusion Criteria:

  • Previous history of secondary prophylactic treatment;
  • Contraindications to treatment of endoscopy, surgery and TIPS
  • Severe cardiac, pulmonary or renal dysfunction;
  • Lactating or pregnant;
  • Malignancies;

Sites / Locations

  • West China Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HVPG group

Routing group

Arm Description

HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG)

Routing therapy (EVL plus NSBB)

Outcomes

Primary Outcome Measures

Variceal rebleeding rate
The incidence of clinically significant gastrointestinal variceal bleeding

Secondary Outcome Measures

Hepatic encephalopathy: The incidence of hepatic encephalopathy
The incidence of hepatic encephalopathy
Ascites: The incidence of ascites detected by ultrasound
The incidence of ascites detected by ultrasound
Cirrhotic complications
portal vein thrombosis, liver dysfunction, hepatorenal syndrome et al.
Liver transplant-free survivial
Time from the procedure to the date of lost-to-follow-up or death or liver transplant

Full Information

First Posted
September 20, 2018
Last Updated
March 11, 2019
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03687216
Brief Title
HVPG-Guided Therapy Versus EVL Plus NSBB in Second Prophylaxis of Esophageal Variceal Bleeding
Official Title
A Single-center Randomized Controlled Study of Secondary Prophylaxis of Cirrhosis Related Esophagogastric Variceal Hemorrhage Treated With HVPG-guided Therapy or Standard Esophageal Variceal Ligation Plus Beta-blocker
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A single-center randomized controlled study comparing endoscopic or interventional therapy guided by the hepatic venous pressure gradient (HVPG) , to standard endosopic variceal ligation plus nonselective beta-blocker therapy (NSBB) in patients with esophageal varices due to liver cirrhosis with a history of esophageal variceal hemorrhage.Primary study outcome of the study is variceal rebleeding episodes occurring within the first years after interventions. Second study outcomes of the study are hepatic encephalopathy occurrence, mortality occurrence, liver transplantation or other cirrhosis-related complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices in Cirrhosis of the Liver

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HVPG group
Arm Type
Experimental
Arm Description
HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG)
Arm Title
Routing group
Arm Type
Active Comparator
Arm Description
Routing therapy (EVL plus NSBB)
Intervention Type
Procedure
Intervention Name(s)
HVPG-guided therapy
Intervention Description
The baseline HVPG measurement is performed. According to the result, patients with an HVPG over 20 mmHg will be receive transjugular intrahepatic portocaval shunt (TIPS) . Patients with an HVPG below 20 mmHg will be treated by endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol until treatment fails.
Intervention Type
Procedure
Intervention Name(s)
Routing Therapy
Intervention Description
Without HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol.
Primary Outcome Measure Information:
Title
Variceal rebleeding rate
Description
The incidence of clinically significant gastrointestinal variceal bleeding
Time Frame
One year of follow-up
Secondary Outcome Measure Information:
Title
Hepatic encephalopathy: The incidence of hepatic encephalopathy
Description
The incidence of hepatic encephalopathy
Time Frame
One year of follow-up
Title
Ascites: The incidence of ascites detected by ultrasound
Description
The incidence of ascites detected by ultrasound
Time Frame
One year of follow-up
Title
Cirrhotic complications
Description
portal vein thrombosis, liver dysfunction, hepatorenal syndrome et al.
Time Frame
One year of follow-up
Title
Liver transplant-free survivial
Description
Time from the procedure to the date of lost-to-follow-up or death or liver transplant
Time Frame
One year of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Liver cirrhosis diagnosed by clinical examination, imaging or biopsy; A previous history of variceal hemorrhage; Written informed consent. Exclusion Criteria: Previous history of secondary prophylactic treatment; Contraindications to treatment of endoscopy, surgery and TIPS Severe cardiac, pulmonary or renal dysfunction; Lactating or pregnant; Malignancies;
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang
Phone
+8618980601276
Email
yangli_hx@scu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HVPG-Guided Therapy Versus EVL Plus NSBB in Second Prophylaxis of Esophageal Variceal Bleeding

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