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Liver Embolization Approaches for Tumor Management

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05714124
Acronym
LEATUM
Enrollment
580
Registered
2023-02-06
Start date
2021-05-21
Completion date
2031-12-31
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma, Hepatocellular Carcinoma, Metastatic Cancer, Metastatic Colon Cancer, Metastatic Gastric Cancer, Metastatic Pancreatic Cancer, Primary Liver Cancer

Keywords

embolization, TAE, TACE, TARE, PVE, HVE

Brief summary

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

PROCEDUREEmbolization

Endovascular treatment for patients with primary and secondary liver tumors

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression free survivalShort term (3-6 months)Treatment Efficacy
Residual hepatic volumewithin 40 days of procedureTreatment Efficacy

Secondary

MeasureTime frameDescription
Overall survivalFrom date of procedure until the date of death from any cause, whichever came first, assessed up to 5 yearsOverall survival

Countries

Italy

Contacts

Primary ContactFrancesco De Cobelli, MD
trialcliniciradiologia@hsr.it+39022643
Backup ContactStephanie Steidler, PhD
steidler.stephanie@hsr.it+39022643

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026