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Liver biopsy during machine perfusion may reveal organ viability before transplant

NCT ID NCT07674394

Knowledge-focused Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study investigates whether examining liver tissue during a cold preservation technique called hypothermic oxygenated machine perfusion can help predict how well the organ will work after transplant. Researchers will compare biopsies taken before and after perfusion and analyze fluid markers of cell damage. The goal is to develop a tool, possibly using artificial intelligence, to better assess donor liver quality and improve transplant safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hypothermic Oxygenated Machine Perfusion (HOPE/D-HOPE)
What this could lead to
If successful, this could lead to a reliable way to assess donor liver quality before transplant, helping doctors decide which organs are safe to use and potentially increasing the number of successful transplants.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. The findings may not apply to all liver types or transplant centers, and the biomarkers might not predict results accurately enough for clinical use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult liver transplant recipients (≥18 years of age). 2. Donor liver grafts from either Donation after Brain Death (DBD) or Donation after Circulatory Death (DCD). 3. Grafts undergoing hypothermic oxygenated perfusion (HOPE) (HOPE or D-HOPE) for a minimum duration of 1 hour prior to transplantation. 4. Availability of two wedge liver biopsy samples: one pre perfusion and one post-perfusion. 5. Grafts preserved using standard cold storage protocols and transported in ice-cold Servator C™ solution. 6. Informed consent obtained from the recipient (or legal representative, where applicable) for the use of clinical and histological data for research purposes. Exclusion Criteria: 1. Inadequate or fragmented biopsy samples, preventing proper histological evaluation. 2. Biopsy samples showing histological features of pre-existing chronic liver disease (e.g., cirrhosis, autoimmune hepatitis, chronic viral hepatitis). 3. Liver grafts subjected to normothermic perfusion or other non hypothermic perfusion techniques. 4. Organs undergoing experimental or non-standard perfusion protocols. 5. Grafts from donors \<18 years of age. 6. Recipient refusal or inability to provide informed consent. 7. Technical failure during perfusion (e.g., incomplete perfusion due to device malfunction or vascular anomalies). 8. Known malignancy in the donor with potential liver involvement, excluding donors with small incidentalomas as per standard guidelines.

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Conditions

The condition(s) this trial relates to.

ischemia reperfusion injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early allograft dysfunction Ischemia reperfusion injury Liver transplantation (LT) Primary non-function

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152, Italy

  • IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione,

    Palermo, 90127, Italy

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