Menu
Recruiting NCT05714124

Liver Embolization Approaches for Tumor Management

Observational Hepatocellular Carcinoma Cholangiocarcinoma Metastatic Colon Cancer Metastatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Embolization.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Cholangiocarcinoma, Metastatic Colon Cancer, Metastatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Embolization
    Endovascular treatment for patients with primary and secondary liver tumors

Primary outcome measures

  • Progression free survival [Time frame: Short term (3-6 months)]
  • Progression free survival [Time frame: 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)]
  • Residual hepatic volume [Time frame: within 40 days of procedure]
Secondary outcome measures (1)
  • Overall survival [Time frame: From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Ospedale San Raffaele — Milan

Identifiers

NCT: NCT05714124 · LEATUM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗