8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding

November 20, 2021 updated by: luo xuefeng, West China Hospital

Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Cirrhosis
  2. Patients who had bled from esophageal varices (≥5days and ≤28days)
  3. Child-Pugh B or Child-Pugh C≤13

Exclusion Criteria:

  1. THE presence of gastric varices
  2. Non-cirrhotic portal hypertension
  3. Portal vein thrombosis
  4. The history of hepatic encephalopathy
  5. Total bilirubin ≥51.3 umol/L
  6. Previous treatment of TIPS or surgery
  7. Proven malignancy including hepatocellular carcinoma
  8. Contraindications to TIPS、EVL or propranolol
  9. End-stage renal disease under renal replacement therapy;
  10. Cardiorespiratory failure
  11. Pregnancy or patients not giving informed consent for endoscopic procedures

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 8mm-TIPS
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
Procedure: 8mm-TIPS
Device: 8mm ePTFE-covered stent
Active Comparator: EVL plus propranolol
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
Drug: Propranolol
Procedure: Endoscopic variceal ligation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variceal rebleeding rate
Time Frame: 3 years
Analysis
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 3 years
Analysis
3 years
Hepatic encephalopathy rate
Time Frame: 3 years
Analysis
3 years
Number of participants with improving or worsening hepatic function
Time Frame: 3 years
Analysis
3 years
TIPS dysfunction rate
Time Frame: 3 years
Analysis
3 years
The incidence of complications
Time Frame: 3 years
Analysis
3 years
Number of participants with improving or worsening quality of life
Time Frame: 3 years
Analysis
3 years

Collaborators and Investigators

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

Sponsor

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 20, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8mm-TIPS

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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