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