Ex-vivo Hypotermic Perfusion in Patients with Hepatocellular Carcinoma to Reduce the Incidence of Tumor Recurrence

NCT06720675 | Completed

• 1 other identifier: HCC-HOPE_2021
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

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

Liver Carcinoma; Liver Transplant; Tumor Recurrence; Hepato Cellular Carcinoma (HCC); Hypothermic Oxygenated Machine Perfusion

Keywords

Ex-vivo machine perfusion; Hepato Cellular Carcinoma - HCC; Liver Transplantation - LT; HCC recurrence after LT; Hypothermic Oxygenated Perfusion - HOPE

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Procedure: Static Cold Storage

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.

Procedure: Hypothermic Oxygented Perfusion

Interventions

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.

HOPE - Hypothermic Oxynated Perfusion

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.

SCS - Static Clod Storage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Related Publications (1)

• 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.

  PMID: 38270476 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matteo Ravaioli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: June 3, 2022
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: January 30, 2025

Record last verified: 2024-10

Locations

IT (1)