Back to results8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding
Primary Purpose
Portal Hypertension
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
8mm-TIPS
Endoscopic variceal ligation
Propranolol
8mm ePTFE-covered stent
Sponsored by
About this trial
This is an interventional treatment trial for Portal Hypertension
Eligibility Criteria
Inclusion Criteria:
- Cirrhosis
- Patients who had bled from esophageal varices (≥5days and ≤28days)
- Child-Pugh B or Child-Pugh C≤13
Exclusion Criteria:
- THE presence of gastric varices
- Non-cirrhotic portal hypertension
- Portal vein thrombosis
- The history of hepatic encephalopathy
- Total bilirubin ≥51.3 umol/L
- Previous treatment of TIPS or surgery
- Proven malignancy including hepatocellular carcinoma
- Contraindications to TIPS、EVL or propranolol
- End-stage renal disease under renal replacement therapy;
- Cardiorespiratory failure
- Pregnancy or patients not giving informed consent for endoscopic procedures
Sites / Locations
- West China Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
8mm-TIPS
EVL plus propranolol
Arm Description
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
Outcomes
Primary Outcome Measures
Variceal rebleeding rate
Analysis
Secondary Outcome Measures
Hepatic encephalopathy rate
Analysis
Number of participants with improving or worsening hepatic function
Analysis
TIPS dysfunction rate
Analysis
The incidence of complications
Analysis
Number of participants with improving or worsening quality of life
Analysis
Mortality rate
Analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02477384
Brief Title
8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding
Official Title
Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
July 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
Detailed Description
For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
8mm-TIPS
Arm Type
Active Comparator
Arm Description
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
Arm Title
EVL plus propranolol
Arm Type
Active Comparator
Arm Description
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
Intervention Type
Procedure
Intervention Name(s)
8mm-TIPS
Intervention Type
Procedure
Intervention Name(s)
Endoscopic variceal ligation
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Type
Device
Intervention Name(s)
8mm ePTFE-covered stent
Primary Outcome Measure Information:
Title
Variceal rebleeding rate
Description
Analysis
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Hepatic encephalopathy rate
Description
Analysis
Time Frame
3 years
Title
Number of participants with improving or worsening hepatic function
Description
Analysis
Time Frame
3 years
Title
TIPS dysfunction rate
Description
Analysis
Time Frame
3 years
Title
The incidence of complications
Description
Analysis
Time Frame
3 years
Title
Number of participants with improving or worsening quality of life
Description
Analysis
Time Frame
3 years
Title
Mortality rate
Description
Analysis
Time Frame
3 years
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:
Cirrhosis
Patients who had bled from esophageal varices (≥5days and ≤28days)
Child-Pugh B or Child-Pugh C≤13
Exclusion Criteria:
THE presence of gastric varices
Non-cirrhotic portal hypertension
Portal vein thrombosis
The history of hepatic encephalopathy
Total bilirubin ≥51.3 umol/L
Previous treatment of TIPS or surgery
Proven malignancy including hepatocellular carcinoma
Contraindications to TIPS、EVL or propranolol
End-stage renal disease under renal replacement therapy;
Cardiorespiratory failure
Pregnancy or patients not giving informed consent for endoscopic procedures
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
33089892
Citation
Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3.
Results Reference
derived
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8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding
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