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

Sichuan University

Status: Completed

Conditions: Portal Hypertension

Treatments: Procedure: 8mm-TIPS; Procedure: Endoscopic variceal ligation; Drug: Propranolol; Device: 8mm ePTFE-covered stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02477384

8mm-TIPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

8mm-TIPS

Active Comparator group

Description:

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

Treatment:

Procedure: 8mm-TIPS

Device: 8mm ePTFE-covered stent

EVL plus propranolol

Active Comparator group

Description:

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

Treatment:

Procedure: Endoscopic variceal ligation

Drug: Propranolol