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

Not Applicable

Completed

• Conditions: Portal Hypertension
• Interventions: Procedure: Endoscopic variceal ligation; Procedure: 8mm-TIPS; Drug: Propranolol; Device: 8mm ePTFE-covered stent

• Registration Number: NCT02477384
• Lead Sponsor: West China Hospital

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.

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-22
• Primary Completion: 2018-11
• Study Completion: 2021-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-20
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVL plus propranolol	Endoscopic variceal ligation	Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
EVL plus propranolol	Propranolol	Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
8mm-TIPS	8mm ePTFE-covered stent	Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
8mm-TIPS	8mm-TIPS	Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.

Primary Outcome Measures

Name	Time	Method
Variceal rebleeding rate	3 years	Analysis

Secondary Outcome Measures

Name	Time	Method
The incidence of complications	3 years	Analysis
Number of participants with improving or worsening hepatic function	3 years	Analysis
Hepatic encephalopathy rate	3 years	Analysis
Number of participants with improving or worsening quality of life	3 years	Analysis
TIPS dysfunction rate	3 years	Analysis
Mortality rate	3 years	Analysis

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China