Clinical trial NCT02715492: Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.
Official title: Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HCC
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with portal vein thrombosis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university - faculty of medicine
Study officials:
affiliation: Prof. liver diseases-Tanta university
name: Osama Negm, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ass/ Prof. liver diseases-Tanta university
name: Sabry Abou Saif, Ass. Prof.
role: STUDY_CHAIR
affiliation: Ass. Prof. interventional radiology - Ain-shams university
name: Mohamed El Gharib, Ass. Prof.
role: STUDY_DIRECTOR
affiliation: MD liver diseases - Tanta university
name: Sherief Abd-Elsalam, Lecturer
role: STUDY_DIRECTOR
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