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

HCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02715492
• Other study ID #: LMWH TACE
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 17, 2016
• Last updated: December 22, 2017
• Start date: October 2018
• Est. completion date: December 2022

Study information

• Verified date: December 2017
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, Lecturer
• Phone: 00201095159522
• Email: Sheriefabdelsalam[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC

Intervention

Drug:
• LMWH
(Enoxheparin) 1 IU/kg per dose twice daily for 2 weeks from the 1st day of TACE

Procedure:
• TACE
Trans arterial chemoembolization

Locations

Country	Name	City	State
Egypt	Tanta university - faculty of medicine	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with portal vein thrombosis		3 months