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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
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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
HCC Drug: LMWH Procedure: TACE 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

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 Name: Enoxaparin

Procedure: TACE
Trans arterial chemoembolization




Primary Outcome Measures :
  1. Number of patients with portal vein thrombosis [ Time Frame: 3 months ]


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Sherief Abd-Elsalam, Lecturer 00201095159522 Sheriefabdelsalam@yahoo.com

Locations
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Egypt
Tanta university - faculty of medicine
Tanta, Egypt
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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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
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Responsible Party: Sherief Abd-Elsalam, MD liver diseases, Tanta University
ClinicalTrials.gov Identifier: NCT02715492    
Other Study ID Numbers: LMWH TACE
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action