8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis
1 other identifier
interventional
72
1 country
1
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 in patients with Child A cirrhosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2017
CompletedStudy Start
First participant enrolled
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2022
CompletedNovember 23, 2021
November 1, 2021
4.9 years
March 23, 2017
November 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Variceal rebleeding rate
Analysis
3 years
Secondary Outcomes (4)
Hepatic encephalopathy rate
3 years
TIPS dysfunction rate
3 years
The incidence of complications
3 years
Mortality rate
3 years
Study Arms (2)
8mm-TIPS
ACTIVE COMPARATORPatients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
EVL plus propranolol
ACTIVE COMPARATORPatients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
Interventions
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.
Appropriate dose of propranolol was administered to the patients.
Eligibility Criteria
You may qualify if:
- Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -
You may not qualify if:
- 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 procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West china hospital
Chengdu, China
Related Publications (1)
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.
PMID: 33089892DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 23, 2017
First Posted
March 29, 2017
Study Start
April 28, 2017
Primary Completion
March 28, 2022
Study Completion
March 28, 2022
Last Updated
November 23, 2021
Record last verified: 2021-11