Liver Embolization Approaches for Tumor Management (LEATUM)

April 11, 2024 updated by: Francesco De Cobelli, IRCCS San Raffaele

Liver Embolization Approaches for Tumor Management - Retrospective and Prospective Analysis of the Short-, Medium-, and Long-term Clinical Course of Patients Subjected to Embolization Treatment for Primary and Secondary Liver Neoplasms

The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
        • Sub-Investigator:
          • Angelo Della Corte, MD
        • Contact:
        • Principal Investigator:
          • Francesco de Cobelli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with primary or secondary liver tumors

Description

Inclusion Criteria:

  • ≥ 18 yoa
  • patients with patients with primary or secondary liver disease not amenable for surgery or ablation
  • patients with primary or secondary liver tumors candidates for major surgery prior to induction of hypertrophy
  • able and willing to sign informed consent

Exclusion Criteria:

  • pregnant women
  • patients with uncorrectable coagulopathy
  • diffuse extrahepatic disease
  • for lobar TACE and TARE - presence of bilodigestive shunt
  • for TARE - >20% hepatopulmonary shunt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Short term (3-6 months)
Treatment Efficacy
Short term (3-6 months)
Progression free survival
Time Frame: From time of intervention up to 1 year (medium term)
From time of intervention up to 1 year (medium term)
Progression free survival
Time Frame: From time of intervention up to 5 years (Long term)
From time of intervention up to 5 years (Long term)
Residual hepatic volume
Time Frame: within 40 days of procedure
Treatment Efficacy
within 40 days of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years
Overall survival
From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEATUM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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