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

NCT03283956 | Unknown

• 1 other identifier: 201708028RINC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma Non-resectable; Chemoembolization, Therapeutic

Outcome Measures

Primary Outcomes (1)

• Safety of the DC bead TACE

  Safety of the DC bead TACE is evaluated based on the incidence of Grade 3 and Grade 4 toxicities up to 8 weeks following the procedure according to National Cancer Institute's Common Terminology Criteria for adverse events (CTCAE Version 4.03).

  One year.

Secondary Outcomes (1)

• Tumor response

  One year.

Study Arms (1)

Patient records

Medical records of all patients who underwent DC bead TACE.

Device: Patient records

Interventions

Patient records 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

Patient records

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Cheng-Kung University Hospital: collaborator
• Taichung Veterans General Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Medical Records

Intervention Hierarchy (Ancestors)

Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Chien-Hung Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Hung Chen, MD

CONTACT

886-2-23123456; chenhcc@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: September 13, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)