Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization

NCT04780789 | Completed

• 1 other identifier: 01-080616/EK
• Study Type: observational
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

The application of transarterial chemoembolisation (TACE) with drug-eluting beads in patients with hepatocellular carcinoma and its response to the treatment will be observed. The registry has the following objectives: To assess the response to the treatment by standard methods and volumetric analysis as well as trying to determine any predictive response factors To determinate interobserver variability of the methods.

Conditions

Hepatocellular Carcinoma; Hepatocellular Carcinoma by BCLC Stage

Keywords

Transarterial Chemoembolization; RECIST; mRECIST; Volumetric analysis

Outcome Measures

Primary Outcomes (2)

• Predictive factors for overall survival and progression-free survival

  RECIST, mRECIST, volumetric analysis

  4 years 11 months

• Interobserver variability of the methods used for assessing tumor response to the treatment

  RECIST, mRECIST, volumetric analysis

  4 years 11 months

Secondary Outcomes (5)

• Time from observation until death due to any cause (or censoring)

  4 years 11 months

• Time from observation until disease progression or death

  4 years 11 months

• Response to the treatment, as assessed by RECIST (v.1.1)

  4 years 11 months

• Response to the treatment, as assessed by mRECIST

  4 years 11 months

• Response to the treatment, as assessed by volumetric analysis

  4 years 11 months

Interventions

Transarterial Chemoembolization PROCEDURE

A contrast agent (Xenetix350, Guerbet, France) was applied under local anaesthesia via the common femoral artery using a 5F sheath. Selective catheterization of the coeliac trunk and other arteries supplying the liver was then performed under fluoroscopic control. A pathological vascularization pattern was identified and chemoembolization material consisting of DC beads (BTG International Ltd) was injected by the treating angiographist using micro instrumentation. Follow-up CT or MRI was performed after 1-3 TACE sessions according to the extent of the lesion, 3 weeks following the last procedure. Patients with completed treatments were scheduled for an imaging follow-up every 3 months, allowing evaluation of the effect of treatment. In case of a positive response to the treatment another session of TACE was indicated. Chemoembolization sessions were performed as inpatient procedures with the mean hospitalization time of 4 days.

Also known as: Transarterial Chemoembolization with Drug-Eluting Beads

Eligibility Criteria

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

Study Population

Patients with hepatocellular carcinoma undergoing transrarterial chemoembolization

You may qualify if:

• diagnosis of HCC by a radiologist according to the European Association for the Study of the Liver (EASL) criteria or confirmed histologically
• at least one TACE undergone at the University Hospital Brno
• initial/ closing CT (Brillance 64, Philips, Netherlands; contrast enhancement 125 mL Iomeron 400, Bracco, Germany) or MRI study (Achieva, Philips, Netherlands, SENSE XL Torso coil 16 1.5T; contrast enhancement 15 mL Primovist, Bayer, Germany)
• follow-up on or before December 31, 2019.

Sponsors & Collaborators

• Brno University Hospital: lead
• Masaryk Memorial Cancer Institute: collaborator
• Masaryk University: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 4, 2021
• Study Start: February 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 4, 2021

Record last verified: 2021-03