NCT02477384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

3.4 years

First QC Date

June 15, 2015

Last Update Submit

November 20, 2021

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (1)

  • Variceal rebleeding rate

    Analysis

    3 years

Secondary Outcomes (6)

  • Hepatic encephalopathy rate

    3 years

  • Number of participants with improving or worsening hepatic function

    3 years

  • TIPS dysfunction rate

    3 years

  • The incidence of complications

    3 years

  • Number of participants with improving or worsening quality of life

    3 years

  • +1 more secondary outcomes

Study Arms (2)

8mm-TIPS

ACTIVE COMPARATOR

Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.

Procedure: 8mm-TIPSDevice: 8mm ePTFE-covered stent

EVL plus propranolol

ACTIVE COMPARATOR

Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.

Procedure: Endoscopic variceal ligationDrug: Propranolol

Interventions

8mm-TIPSPROCEDURE
8mm-TIPS
Endoscopic variceal ligationPROCEDURE
EVL plus propranolol
PropranololDRUG
EVL plus propranolol
8mm ePTFE-covered stentDEVICE
8mm-TIPS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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 procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (2)

  • Wang X, Liu G, Wu J, Xiao X, Yan Y, Guo Y, Yang J, Li X, He Y, Yang L, Luo X. Small-Diameter Transjugular Intrahepatic Portosystemic Shunt versus Endoscopic Variceal Ligation Plus Propranolol for Variceal Rebleeding in Advanced Cirrhosis. Radiology. 2023 Aug;308(2):e223201. doi: 10.1148/radiol.223201.

    PMID: 37606572DERIVED

  • 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

Hypertension, Portal

Interventions

Portasystemic Shunt, Transjugular IntrahepaticPropranolol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical ProceduresPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 22, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2018

Study Completion

July 1, 2021

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

CN(1)