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

NCT ID: NCT02715492

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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HCC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Transarterial Chemoembolization

1st group: included 20 patients with HCC treated by TACE only.

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

Trans arterial chemoembolization

TACE and LMWH

2nd group: included 20 patients with HCC treated by TACE and adjuvant dose of Low Molecular Weight Heparins (LMWH).

Group Type EXPERIMENTAL

LMWH

Intervention Type DRUG

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

TACE

Intervention Type PROCEDURE

Trans arterial chemoembolization

Interventions

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LMWH

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

Intervention Type DRUG

TACE

Trans arterial chemoembolization

Intervention Type PROCEDURE

Other Intervention Names

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Enoxaparin

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

MD liver diseases

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Osama Negm, Prof

Role: PRINCIPAL_INVESTIGATOR

Prof. liver diseases-Tanta university

Sabry Abou Saif, Ass. Prof.

Role: STUDY_CHAIR

Ass/ Prof. liver diseases-Tanta university

Mohamed El Gharib, Ass. Prof.

Role: STUDY_DIRECTOR

Ass. Prof. interventional radiology - Ain-shams university

Sherief Abd-Elsalam, Lecturer

Role: STUDY_DIRECTOR

MD liver diseases - Tanta university

Locations

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Tanta university - faculty of medicine

Tanta, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, Lecturer

Role: CONTACT

Phone: 00201095159522

Email: [email protected]

Other Identifiers

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LMWH TACE

Identifier Type: -

Identifier Source: org_study_id