Clinical trial · Observational
Ex-vivo Hypotermic Perfusion in Patients With Hepatocellular Carcinoma to Reduce the Incidence of Tumor Recurrence
Use of Ex-vivo Hypotermic Perfusion in Patients With Hepatocellular Carcinoma Candidates for Liver Transplant to Reduce the Incidence of Tumor Recurrence
NCT06720675CI-TRIAL-00085282completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a retrospective study of single-center cohorts that involves patients with HCC who underwent liver transplantation between January 2016 and 2021, who received livers preserved with Hypothermic Oxygenated Perfusion (HOPE) or Static Cold Storage (SCS) with a minum follow up of 12 months.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepato Cellular Carcinoma (HCC) | — | UNRESOLVED | — |
| Hypothermic Oxygenated Machine Perfusion | — | UNRESOLVED | — |
| Liver Carcinoma | Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Transplant | — | UNRESOLVED | — |
| Tumor Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypothermic Oxygented Perfusion | Procedure | — | UNRESOLVED |
| Static Cold Storage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SCS - Static Clod Storage
- description
- HCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with SCS and a minimum follow-up of 12 months.
- interventionNames
- Procedure: Static Cold Storage
- label
- HOPE - Hypothermic Oxynated Perfusion
- description
- HCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with HOPE and a minimum follow-up of 12 months.
- interventionNames
- Procedure: Hypothermic Oxygented Perfusion
Primary outcomes (1)
- measure
- Risk of HCC tumour recurrence
- timeFrame
- From liver transplant to twelve months after LT
- description
- For the purposes of descriptive analyses, categorical variables will be expressed as frequency and percentage; continuous variables will be expressed as mean + standard deviation (SD) or with median and inter-quartile range (IQR) depending on their distributive form. Comparisons between the two groups will be made by means of Chi-Quadro tests or Fisher's test (categorical variables), t-tests or Mann-Whitney tests (means of continuous variables, depending on their type of distribution). Multiple logistic regression models will be used to identify factors associated with the appearance of tumour recurrence, in which the graft preservation method is considered as a risk factor and the main characteristics of recipient and donor are included as potential confounders. Survival analysis using Kaplan-Meier curves, log-rank test and Cox regression will be performed to assess the time between transplantation and recurrence and the factors associated with it.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recipients aged 18 years or older with previous diagnosis of HCC, undergone Liver Transplantation at the Transplant Center of the IRCCS AOUBO between January 2016 and 2021 * Patients who have given informed consent to participate in the study Exclusion Criteria: * none
References
Publications (1)
- RESULTDajti G, Germinario G, Prosperi E, Siniscalchi A, Vasuri F, Valente S, Odaldi F, Maroni L, Serenari M, Bertuzzo V, Laurenzi A, Del Gaudio M, Cescon M, Ravaioli M. The role of cold ischemia time and hypothermic perfusion in predicting early hepatocellular carcinoma recurrences after liver transplantation. Artif Organs. 2024 Jun;48(6):619-625. doi: 10.1111/aor.14715. Epub 2024 Jan 25. PMID 38270476