- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03723304
The Intention-to-treat Effect of Bridge Therapies in the Setting of Milan-in Patients
The Intention-to-treat Effect of Bridging Therapies in the Setting of Milan-in Patients Waiting for Liver Transplantation
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Liver transplantation (LT) is the best curative treatment of hepatocellular cancer (HCC) developed in an underlying liver disease. LT is considered as an oncologic successful procedure when a long-term post-transplant tumour-free survival is obtained. Conversely, a failure is equal to pre-transplant drop-out, post-transplant tumour recurrence or death. Due to the allograft scarcity, a HCC patient waiting for a LT is most often treated using neo-adjuvant loco-regional therapies (LRT) in order to minimise the risk of drop-out. When the tumour burden meets the Milan Criteria (MC) at moment of diagnosis, such an approach is called "bridging towards LT".
Two recent international guidelines underlined the importance of the bridging strategy, due to its potential to reduce the risk of pre-LT drop-out and post-LT recurrence. This is especially valid in the case in which a partial/complete tumour response is achieved before LT. Unfortunately, the quality of the evidence obtained from the currently available literature is low due to the lack of randomized controlled trials (RCT). Actually, it is inconceivable to realize RCT in this setting because of logistical and, even more, ethical reasons. Consequently, the majority of reported studies just compare post-LT outcome of treated and untreated patients, failing thereby to analyse the clinical course from an intention-to-treat (ITT) point of view.
Even when looking at studies including the waiting list period, one should keep in mind that substantial differences may exist among initially bridged vs untreated HCC patients regarding tumour burden. In order to overcome these limits, a retrospective analysis of a large European population of MC-IN HCC patients listed for LT was done. After "balancing" this cohort with an inverse probability of treatment weighting (IPTW), we investigated the risk factors for tumour-specific LT failure, especially focusing at the role of LRT.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Brussels, Belgien
- UCL
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- adults (≥18-year old) listed for liver transplant with a morphologic and/or histologic confirmed hepatocellular cancer
Exclusion Criteria:
- Milan Criteria-out status at first referral
- transplantation or de-listing before January 1, 2001
- other means of loco-regional treatments such as partial hepatectomy, trans-arterial radio-embolization or external radiotherapy
- misdiagnosed mixed hepatocellular-cholangiocellular cancer or cholangiocellular cancer
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Direct liver transplant
All the cases listed for liver transplantation and then transplanted/dropped-out without undergoing any neo-adjuvant loco-regional treatment
|
Direct liver transplant (no neoadjuvant approaches during the waiting time period)
|
Bridging followed by transplant
All the cases listed for liver transplantation and then transplanted/dropped-out after undergoing at least one neo-adjuvant loco-regional treatment
|
Trans-arterial chemoembolization or percutaneous alcohol injection or radio-frequency ablation during the waiting time followed by liver transplant
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Tumour-specific liver transplant failure rate
Tidsram: up to 5 years from first referral
|
Any case of tumor-related drop-out during the waiting list period or post-transplant recurrence
|
up to 5 years from first referral
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Quirino Lai, MD PhD, UCL Brussels
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- #0002
Plan för individuella deltagardata (IPD)
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