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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.
The gold standard treatment for Hepatocellular Carcinoma (HCC) is Liver Transplantation (LT) but, despite its success, it maintains cancer recurrence rates of 16%. Ischemia-reperfusion injury (IRI) is considered a major determinant of the higher rate of HCC recurrence associated with transplantation from ECD donors and/or organs with ischemic damage. In this field, the treatment with Machines Perfusion (MP) of the liver has gained increasing attention in the transplant community as a useful tool to relieve IRI, test the hepatic function before transplantation and potentially reconditioning the marginal organs. The current study aims to show that Hypothermic Oxygenated Perfusion (HOPE) can protect recipients not only from IRI and post-transplant complications but also from tumour recurrence, which appears to be inevitably linked to the quality of the organ. This will be done through the comparison between a retrospective group of patients with HCC who have undergone LT with graft preserved by HOPE and a retrospective group of HCC recipients who received grafts preserved without perfusion, but with Static Cold Storage (SCS) technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCS - Static Clod Storage | HCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with SCS and a minimum follow-up of 12 months. |
| |
| HOPE - Hypothermic Oxynated Perfusion | HCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with HOPE and a minimum follow-up of 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypothermic Oxygented Perfusion | Procedure | HOPE start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid (cold Belzer MPS solution) during back-table preparation. Hepatic perfusion was performed through the vein leads to a pressure of 3-5 mmHg. Organ were treated with continuous HOPE until transplant and the perfusion was continuously monitored and data downloaded in a USB memory. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of HCC tumour recurrence | 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. | From liver transplant to twelve months after LT |
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Inclusion Criteria:
Exclusion Criteria:
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All HCC patients transplanted between January 2016 and 2021 who received liver grafts preserved with HOPE or SCS and minimum 12 months of follow-up will be included in the study. The diagnosis of HCC was confirmed in accordance with the recommendations of international guidelines issued during the period corresponding to the diagnosis. Of these patients, demographic data, clinical parameters, laboratory data and cancer parameters will be collected, including the number of tumors, size, maximum diameter, total tumor diameter, satellite nodules, microvascular invasion, the grade, classification and stage of the tumour. Donor characteristics and post-transplant clinical data of recipients will be collected too.
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| Name | Affiliation | Role |
|---|---|---|
| Matteo Ravaioli, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38270476 | Result | Dajti 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. |
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| Static Cold Storage | Procedure | Liver grafts are stored in sterile organ bags with cold Belzer or Celsior solution and kept in ice at 4°C. |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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