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Completed

NCT Number: NCT02477384

8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) 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.

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Key information

Conditions

Portal Hypertension Digestive System Diseases Hypertension, Portal Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

8mm-TIPS

Procedure

Endoscopic Variceal Ligation

Procedure

Propranolol

Drug

8mm ePTFE-covered stent

Device

Primary outcomes

  1. Variceal rebleeding rate

    Time frame: 3 years

    Analysis

Secondary outcomes

  1. Hepatic encephalopathy rate

    Time frame: 3 years

    Analysis

  2. Number of participants with improving or worsening hepatic function

    Time frame: 3 years

    Analysis

  3. TIPS dysfunction rate

    Time frame: 3 years

    Analysis

  4. The incidence of complications

    Time frame: 3 years

    Analysis

  5. Number of participants with improving or worsening quality of life

    Time frame: 3 years

    Analysis

  6. Mortality rate

    Time frame: 3 years

    Analysis

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2021
First posted
Jun 22, 2015
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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