Extension of Liver Transplantation Opportunity to Patients Suffering From Milan-out, Up-to-7-in, Hepatocellular Carcinoma: a Prospective Belgian Study of the Value of Negative 18FDG PET/CT

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

Hepatocellular carcinoma (HCC) is a rising public health concern with few curative options but liver transplantion (LT) in highly selected cases. LT could save many other HCC patients but organ shortage has lead to the necessity of selection of patients with the best survival chances, namely the Milan criteria. Hepatocellular carcinoma (HCC) is the fifth most common cancer, and the third cause of cancer related-death worldwide. HCC incidence is rising in Western countries including Belgium. There are more than 1,000 new HCC diagnoses in Belgium every year, but only 90 to 100 patients suffering from HCC are listed for liver transplantation (LT). In fact, the scarcity of organ donors has forced the development of strict criteria to limit LT to patients who are likely to have excellent outcomes. The universally accepted LT criteria for HCC are the Milan criteria (1 HCC nodule ≤5 cm or 3 nodules ≤3cm) that lead to a low rate of post-LT recurrence (\>80% of disease free recurrence at 5 years). The majority of patients suffering from HCC outside the Milan criteria at the time of diagnosis is not eligible for LT and is therefore limited to palliative care. It is however considered that some of these patients with HCC outside the Milan criteria may benefit from LT with an acceptable risk of recurrence and chances of long-term disease-free survival (DFS). This fact has led to the extension of LT criteria for HCC in some centres in different countries, as for example the University of California San Francisco (UCSF) criteria, the up-to-seven criteria or the Asan criteria. The Belgian Liver-Intestine Allocation Committee (Be-LIAC) is a section of the Belgian Transplantation Society (BTS) composed of the 6 LT Belgian centres in charge of coordinating deceased LT activity in Belgium with the help of Eurotransplant. Be-LIAC has already built a retrospective HCC database that was successfully used for several scientific studies allowing international presentations and publications. Based on this successful experience, Be-LIAC is keen to continue with this national collaboration to initiate a prospective clinical observational database to better study the results of LT in Belgium and to evaluate potential of extension of LT criteria in HCC patients. Inclusion in this database will not change patient management or the allocation process of the liver grafts in Belgium. This project is financed by a 4-year (2019-2022) grant of the Belgian Fondation contre le cancer / Stichting tegen Kanker.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• HepatoCellular Carcinoma

• Liver transplant candidate after multidisciplinary disccuss

Locations
Other Locations
Belgium
University Hospital, Antwerp
RECRUITING
Antwerp
Free University of Brussels
RECRUITING
Brussels
University Hospital, Ghent
RECRUITING
Ghent
Catholic University of Louvain
RECRUITING
Leuven
Leuven University hospital
RECRUITING
Leuven
ULiège
RECRUITING
Liège
Contact Information
Primary
Olivier Detry, MD PhD
olivier.detry@chuliege.be
003242844757
Backup
Céline Lambrecht
celine.lambrecht@chuliege.be
003243678323
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 350
Treatments
Study group
Milan-out, up-to-7-in, PET negative (≤1.15) HCC patients
Control group
Milan-in HCC patients
Related Therapeutic Areas
Sponsors
Leads: University of Liege
Collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Universitaire Ziekenhuizen KU Leuven, University Hospital, Antwerp, Free University of Brussels, University Hospital, Ghent

This content was sourced from clinicaltrials.gov