Liver Embolization Approaches for Tumor Management

NCT ID: NCT05714124

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

580 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-21

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Embolization

Endovascular treatment for patients with primary and secondary liver tumors

Intervention Type PROCEDURE

Other Intervention Names

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Transarterial Chemoembolisation Transarterial Radioembolization Bland Transarterial Embolization Hepatic Vein Embollization Portal Vein Embolization

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Francesco De Cobelli

Head of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco De Cobelli, MD

Role: CONTACT

+39022643 ext. 2529

Stephanie Steidler, PhD

Role: CONTACT

+39022643 ext. 6111

Facility Contacts

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Francesco De Cobelli, MD

Role: primary

+39022643 ext. 2529

Stephanie Steidler, PhD

Role: backup

+39022643 ext. 6111

Other Identifiers

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LEATUM

Identifier Type: -

Identifier Source: org_study_id

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