8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis

Sponsor

West China Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03094234

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

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 in patients with Child A cirrhosis

Condition or Disease	Intervention/Treatment	Phase
Portal Hypertension	Device: 8mm-TIPS Procedure: endoscopic variceal ligation (EVL) Drug: Propranolol	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

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis

Actual Study Start Date :

Apr 28, 2017

Anticipated Primary Completion Date :

Mar 28, 2022

Anticipated Study Completion Date :

Mar 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 8mm-TIPS Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.	Device: 8mm-TIPS Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
Active Comparator: EVL plus propranolol Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.	Procedure: endoscopic variceal ligation (EVL) Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment. Drug: Propranolol Appropriate dose of propranolol was administered to the patients.

Arm

Intervention/Treatment

Active Comparator: 8mm-TIPS

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

Device: 8mm-TIPS

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

Active Comparator: EVL plus propranolol

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

Procedure: endoscopic variceal ligation (EVL)

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

Drug: Propranolol

Appropriate dose of propranolol was administered to the patients.

Outcome Measures

Primary Outcome Measures

Variceal rebleeding rate [3 years]
Analysis

Secondary Outcome Measures

Hepatic encephalopathy rate [3 years]
Analysis
TIPS dysfunction rate [3 years]
Analysis
The incidence of complications [3 years]
Analysis
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:

Inclusion Criteria:

Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -

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 procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West china hospital	Chengdu		China

Sponsors and Collaborators

West China Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

luo xuefeng, Principal Investigator, West China Hospital

ClinicalTrials.gov Identifier:

NCT03094234

Other Study ID Numbers:

8mm-TIPS-ChildA

First Posted:

Mar 29, 2017

Last Update Posted:

Nov 23, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension, Portal

Propranolol

Study Results

No Results Posted as of Nov 23, 2021