Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis

Phase 4

Completed

• Conditions: Hepatocellular Carcinoma (HCC)
• Interventions: Procedure: transarterial chemoembolization versus the standard treatment with sorafinib

• Registration Number: NCT03007212
• Lead Sponsor: Ain Shams University

Brief Summary

Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess the outcomes after TACE in patients with branch PVT regarding Child classification, radiological response and 1 year survival.

Detailed Description

Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory investigations including liver function tests to assess deterioration in liver functions, triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival analysis was performed using Kaplan-Meier estimations.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-12
• Study First Submitted: 2016-12-24
• Study First Submitted QC: 2016-12-29
• Last Update Submitted: 2016-12-29
• Study First Posted: 2017-01-02
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with newly diagnosed HCC,
• Child class A and
• Portal vein branch tumoral thrombus (proved by imaging)
• written informed consent

Exclusion Criteria

• patients with Child class B and C,
• main Portal vein thrombosis,
• previous management for HCC,
• Arterio-portal shunt
• refused to be enrolled

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCC patients with Pranch portal vein thrombosis	transarterial chemoembolization versus the standard treatment with sorafinib	Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory investigations including liver function tests to assess deterioration in liver functions, triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival analysis was performed using Kaplan-Meier estimations.

Primary Outcome Measures

Name	Time	Method
changes in Radiological Response in the (CT/ MRI) after the intervention	1 year