Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.
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|ClinicalTrials.gov Identifier: NCT02715492|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2016
Last Update Posted : December 27, 2017
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|
|HCC||Drug: LMWH Procedure: TACE||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Active Comparator: Transarterial Chemoembolization
1st group: included 20 patients with HCC treated by TACE only.
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).
(Enoxheparin) 1 IU/kg per dose twice daily for 2 weeks from the 1st day of TACE
Other Name: Enoxaparin
Trans arterial chemoembolization
- Number of patients with portal vein thrombosis [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715492
|Contact: Sherief Abd-Elsalam, Lecturer||00201095159522||Sheriefabdelsalam@yahoo.com|
|Tanta university - faculty of medicine|
|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|