Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.

Phase 3

• Conditions: HCC
• Interventions: Procedure: TACE; Drug: LMWH

• Registration Number: NCT02715492
• Lead Sponsor: Sherief Abd-Elsalam

Brief Summary

Hepatocellular carcinoma (HCC) is a major health problem worldwide, and most cases are inoperable because of late presentation and underlying cirrhosis. It represents the fifth most common tumor in the world and the third most frequent cause of mortality amongst patients with cancer.

Due to the worldwide difficulties in finding liver for transplantation, hepatic resection (HR) represents the main stay of curative treatment for patients with HCC. Transcatheter arterial chemoembolization (TACE) is widely used as alternative treatments for unresectable HCC or for patients not eligible to be operated on .

TACE also could be an adjuvant therapy for resectable HCC patients after hepatectomy, which could prevent recurrence and improve long-term survival .

Detailed Description

Thromboembolism is a well-recognised complication of malignant disease. Clinical manifestations vary from venous thromboembolism to disseminated intravascular coagulation and arterial embolism. Disseminated intravascular coagulation is most commonly observed in patients with haematological malignant disorders and those with wide spread metastatic cancer, whereas arterial embolism is most commonly observed in patients undergoing chemotherapy and in those with non-bacterial thrombotic endocarditis .

The goals of using antithrombotic therapy with TACE in HCC are to minimize mortality and to improve survival rate without provoking excessive bleeding.

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-22
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-22
• Last Update Posted: 2017-12-27
• Study Start: 2018-10
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• HCC which was not amenable to surgical resection, liver transplantation or local ablative therapy.
• The lesion had not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
• Reasonable performance status as adequate hematologic function; adequate hepatic function and adequate renal function.
• Child-Pugh class A or B and no portal vein thrombosis.

Exclusion Criteria

• Child C patients Portal vein thrombosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transarterial Chemoembolization	TACE	1st group: included 20 patients with HCC treated by TACE only.
TACE and LMWH	LMWH	2nd group: included 20 patients with HCC treated by TACE and adjuvant dose of Low Molecular Weight Heparins (LMWH).
TACE and LMWH	TACE	2nd group: included 20 patients with HCC treated by TACE and adjuvant dose of Low Molecular Weight Heparins (LMWH).

Primary Outcome Measures

Name	Time	Method
Number of patients with portal vein thrombosis	3 months

Trial Locations

Locations (1)

Tanta university - faculty of medicine; 🇪🇬 Tanta, Egypt