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

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

NCT02477384•West China Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (1)

West China Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

June 1, 2015

Primary Completion Date

November 1, 2018

Completion Date

July 1, 2021

Last Updated

December 2, 2021

Enrollment

100

ACTUAL participants

Conditions

Portal Hypertension

Interventions

8mm-TIPS

PROCEDURE

Endoscopic variceal ligation

PROCEDURE

Propranolol

DRUG

8mm ePTFE-covered stent

DEVICE

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITING

TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease

NCT07163689

TIPSPortal Hypertension+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease

Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease

The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients

Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts