Discrepancies in Management of Hepatocellualr Carcinoma Between Practice and Recommendations

Management of Hepatocellular Carcinoma : Discrepancies Between BCLC Classification and Clinical Practice in a Large Regional Multicentric Cohort

The complex management of hepatocellular carcinoma has prompted many learned societies to issue their management recommendations or decision-making algorithms to best assist in the therapeutic decision-making of patients with HCC. Over time, the use of the BCLC algorithm (for Barcelona Clinic Liver Cancer) has become essential, at least in the West, thanks to a relatively simple and applicable classification system, and the clinical validation of numerous studies. The BCLC algorithm thus relies on the general condition of the patient, the CHILD-PUGH score reflecting hepatic function, and the tumor extension to propose one or more therapeutic solutions according to the level of scientific evidence, associating with each one. subgroups the expected survival.

While this BCLC classification has the merit of having the protocol for the management of HCC, thus avoiding many drifts related to possible local preferences, it also has many defects. For example, this classification is only rarely updated, which limits the integration of innovative therapies. Then, its design and updates were supported by the recommendations of a limited group of experts that is not necessarily representative of all the key players present daily in the management of CHC. Finally, some studies have begun to point out that this classification was interesting from a theoretical point of view, but that in practice the diversity of complex situations meant that its care recommendations were not applicable in a significant number of cases.

The objective of our study is to analyze the applicability of the BCLC classification in real-life situations. To overcome possible "center effects", the investigators analyzed in an exhaustive way the therapeutic decisions taken during the multi-disciplinary consultation meetings of 2018 and 2019 at the level of a large French region, by relying on the regional network of OncoOccitanie Oncology Record. In a second step, the investigators will analyze the causes of the discrepancies to finally propose an improvement of this BCLC classification.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patient with diagnosis of HCC proven based on tumor sampling or imaging findings

Description

Inclusion criteria:

- Any patient presented at a multidisciplinary meeting within the OncoOccitanie network during the years 2018 and 2019 for the management of hepatocellular carcinoma

Exclusion criteria:

• Histological type other than CHC
• Multidisciplinary meeting that does not lead to a therapeutic decision (such as the continuation of further investigations, biopsy sampling, or active surveillance)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of therapeutic proposals correctly predicted by the BCLC international classification	Rate of therapeutic proposals correctly predicted by the BCLC international classification	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates and causes of discrepancies	Rates and causes of discrepancies	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: BORIS GUIU, PU-PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Anticipated): December 25, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: HCC; Therapy; Interventional Radiology; resection; Chronic liver diseases; Surgical
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: RECHMPL19_0572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No