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

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National Taiwan University

Status

Unknown

Conditions

Hepatocellular Carcinoma Non-resectable
Chemoembolization, Therapeutic

Treatments

Device: Patient records

Study type

Observational

Funder types

Other

Identifiers

NCT03283956
201708028RINC

Details and patient eligibility

About

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

Full description

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.

Enrollment

500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Patient records
Description:
Medical records of all patients who underwent DC bead TACE.
Treatment:
Device: Patient records

Trial contacts and locations

1

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Central trial contact

Chien-Hung Chen, MD

Data sourced from clinicaltrials.gov

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