LEATUM: Liver Embolization Approaches for Tumor Management

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Recruiting

CT.gov ID

NCT05714124

Collaborator

(none)

580

Enrollment

Location

127.3

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Cholangiocarcinoma Metastatic Colon Cancer Metastatic Cancer Metastatic Gastric Cancer Primary Liver Cancer Metastatic Pancreatic Cancer	Procedure: Embolization

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

580 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

May 21, 2021

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2031

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival [From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years]
Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale San Raffaele	Milan		Italy	20132

Sponsors and Collaborators

IRCCS San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Francesco De Cobelli, Head of Radiology, IRCCS San Raffaele

ClinicalTrials.gov Identifier:

NCT05714124

Other Study ID Numbers:

LEATUM

First Posted:

Feb 6, 2023

Last Update Posted:

Feb 6, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Francesco De Cobelli, Head of Radiology, IRCCS San Raffaele

embolization, TAE, TACE, TARE, PVE, HVE

Additional relevant MeSH terms:

Cholangiocarcinoma

Study Results

No Results Posted as of Feb 6, 2023