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

Sichuan University

Status: Unknown

Conditions: Portal Hypertension

Treatments: Procedure: endoscopic variceal ligation (EVL); Device: 8mm-TIPS; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT03094234

8mm-TIPS-ChildA

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 in patients with Child A cirrhosis

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: 72 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 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:

Device: 8mm-TIPS

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 (EVL)

Drug: Propranolol