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

Sponsor
West China Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02477384
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
73
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 8mm-TIPS
  • Procedure: Endoscopic variceal ligation
  • Drug: Propranolol
  • Device: 8mm ePTFE-covered stent
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

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.

Procedure: Endoscopic variceal ligation

Drug: Propranolol

Outcome Measures

Primary Outcome Measures

  1. Variceal rebleeding rate [3 years]

    Analysis

Secondary Outcome Measures

  1. Hepatic encephalopathy rate [3 years]

    Analysis

  2. Number of participants with improving or worsening hepatic function [3 years]

    Analysis

  3. TIPS dysfunction rate [3 years]

    Analysis

  4. The incidence of complications [3 years]

    Analysis

  5. Number of participants with improving or worsening quality of life [3 years]

    Analysis

  6. Mortality rate [3 years]

    Analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital Chengdu Sichuan China 610041

Sponsors and Collaborators

  • West China Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
luo xuefeng, MD, West China Hospital
ClinicalTrials.gov Identifier:
NCT02477384
Other Study ID Numbers:
  • 8mm-TIPS
First Posted:
Jun 22, 2015
Last Update Posted:
Dec 2, 2021
Last Verified:
Nov 1, 2021
Additional relevant MeSH terms:
Hypertension, Portal
Propranolol

Study Results

No Results Posted as of Dec 2, 2021