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Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan

NCT ID: NCT03283956

Last Updated: 2017-09-15

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

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-13

Study Completion Date

2018-08-31

Brief Summary

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To evaluate efficacy and safety profile of DC bead® TACE in patients with hepatocellular carcinoma in Taiwan.

Detailed Description

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To evaluate efficacy and safety profile of DC bead TACE in patients with hepatocellular carcinoma in Taiwan.

This is a multi-center, retrospective, single arm study to explore safety and efficacy of DC bead TACE in hepatocellular carcinoma (HCC) in Taiwan

Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7.

All statistical data were analyzed with SPSS software (SPSS, IBM North America, New York, NY, USA). Demographic and baseline lab data are presented by using descriptive statistics Student's t-test. Survival analysis will includes all patients.

Conditions

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Hepatocellular Carcinoma Non-resectable Chemoembolization, Therapeutic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient records

Medical records of all patients who underwent DC bead TACE.

Patient records

Intervention Type DEVICE

Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7

Interventions

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Patient records

Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of HCC, according to the AASLD diagnosis criteria for HCC.
* Patient received DC bead TACE.

Exclusion Criteria

* Patients with current any other cancer except non-melanomatous skin cancer.
* Infiltrative HCC
* Patients received ≥2 consecutive sessions of TACE (≥2 TACE at the same admission, no matter it is cTACE or DC bead TACE)
* Patients received DC bead TACE and simultaneously received other therapy, such as radiotherapy, sorafenib etc.
* Presence of collateral vessel pathways potentially endangering normal territories during embolization.
* Presence of arteries supplying the lesion not large enough to accept DC Bead® microspheres.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

Taichung Veterans General Hospital

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chien-Hung Chen, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Chien-Hung Chen, MD

Role: CONTACT

[email protected]
886-2-23123456 ext. 65923

Facility Contacts

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Chien-Hung Chen, MD

Role: primary

[email protected]
886-2-23123456 ext. 65923

Other Identifiers

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201708028RINC

Identifier Type: -

Identifier Source: org_study_id