Liver Embolization Approaches for Tumor Management

Hepatocellular Carcinoma Clinical Trial

— LEATUM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714124
• Other study ID #: LEATUM
• Status: Recruiting
• Start date: May 21, 2021
• Est. completion date: December 31, 2031

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: Francesco De Cobelli, MD
• Phone: +39022643
• Email: trialcliniciradiologia[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Treatment Efficacy	Short term (3-6 months)
Primary	Progression free survival		From time of intervention up to 1 year (medium term)
Primary	Progression free survival		From time of intervention up to 5 years (Long term)
Primary	Residual hepatic volume	Treatment Efficacy	within 40 days of procedure
Secondary	Overall survival	Overall survival	From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years