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

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ClinicalTrials.gov Identifier: NCT03007212

Recruitment Status : Completed

First Posted : January 2, 2017

Last Update Posted : January 2, 2017

Sponsor:

Information provided by (Responsible Party):

Iman Fawzy Montasser, Ain Shams University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma (HCC)	Procedure: transarterial chemoembolization versus the standard treatment with sorafinib	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	September 2014
Actual Primary Completion Date :	September 2015
Actual Study Completion Date :	September 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: HCC patients with Pranch portal vein thrombosis 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.	Procedure: transarterial chemoembolization versus the standard treatment with sorafinib TACE procedures were performed by the interventional radiologist through femoral artery approach in all patients. Super-selective cannulation of the main feeders was performed using a microcatheter whenever possible. The c-TACE protocol consisted of intra-arterial infusion of cisplatin 50-100 mg mixed with lipiodol ,Just prior to injection, emulsion is prepared by intensive mixing of equal volumes of cytotoxic drug solution and iodized oil using the pumping method with two syringes and a three way stop cock. Injection is guided by fluoroscopy and results in dense accumulation of the emulsion within the tumor vascular bed. Injection of poor iodized oil up to a maximum volume of 10-20 cc is an option and is followed by embolization of feeding arteries by Gelfoam cubes .Endpoints of conventional TACE are complete filling of the tumor vascular bed with iodized oil and stop-flow in subsegmental and segmental feeding arteries..

Arm

Intervention/treatment

Experimental: HCC patients with Pranch portal vein thrombosis

Procedure: transarterial chemoembolization versus the standard treatment with sorafinib

TACE procedures were performed by the interventional radiologist through femoral artery approach in all patients. Super-selective cannulation of the main feeders was performed using a microcatheter whenever possible. The c-TACE protocol consisted of intra-arterial infusion of cisplatin 50-100 mg mixed with lipiodol ,Just prior to injection, emulsion is prepared by intensive mixing of equal volumes of cytotoxic drug solution and iodized oil using the pumping method with two syringes and a three way stop cock. Injection is guided by fluoroscopy and results in dense accumulation of the emulsion within the tumor vascular bed. Injection of poor iodized oil up to a maximum volume of 10-20 cc is an option and is followed by embolization of feeding arteries by Gelfoam cubes .Endpoints of conventional TACE are complete filling of the tumor vascular bed with iodized oil and stop-flow in subsegmental and segmental feeding arteries..

Outcome Measures

Primary Outcome Measures :

changes in Radiological Response in the (CT/ MRI) after the intervention [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

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Responsible Party:	Iman Fawzy Montasser, Associate professor of tropical medicine , Ain Shams university, Ain Shams University
ClinicalTrials.gov Identifier:	NCT03007212
Other Study ID Numbers:	Hepatocellular Carcinoma
First Posted:	January 2, 2017 Key Record Dates
Last Update Posted:	January 2, 2017
Last Verified:	December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

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Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma	Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases

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