Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.
Study Details
Study Description
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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Transarterial Chemoembolization 1st group: included 20 patients with HCC treated by TACE only. |
Procedure: TACE
Trans arterial chemoembolization
|
| Experimental: TACE and LMWH 2nd group: included 20 patients with HCC treated by TACE and adjuvant dose of Low Molecular Weight Heparins (LMWH). |
Drug: LMWH
(Enoxheparin) 1 IU/kg per dose twice daily for 2 weeks from the 1st day of TACE
Other Names:
Procedure: TACE
Trans arterial chemoembolization
|
Outcome Measures
Primary Outcome Measures
- Number of patients with portal vein thrombosis [3 months]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tanta university - faculty of medicine | Tanta | Egypt |
Sponsors and Collaborators
- Sherief Abd-Elsalam
Investigators
- Principal Investigator: Osama Negm, Prof, Prof. liver diseases-Tanta university
- Study Chair: Sabry Abou Saif, Ass. Prof., Ass/ Prof. liver diseases-Tanta university
- Study Director: Mohamed El Gharib, Ass. Prof., Ass. Prof. interventional radiology - Ain-shams university
- Study Director: Sherief Abd-Elsalam, Lecturer, MD liver diseases - Tanta university
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LMWH TACE