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NCT Number: NCT05714124

Liver Embolization Approaches for Tumor Management

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Metastatic Cancer Metastatic Colon Cancer Metastatic Gastric Cancer Metastatic Pancreatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Liver Cancer Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location status: Recruiting

Location contact

Angelo Della Corte, MD

SUB_INVESTIGATOR

Francesco De Cobelli, MD

CONTACT

[email protected]

+39022643 ext. 2529

Francesco De Cobelli, MD

PRINCIPAL_INVESTIGATOR

Stephanie Steidler, PhD

CONTACT

[email protected]

+39022643 ext. 6111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

embolization

Procedure

Endovascular treatment for patients with primary and secondary liver tumors

Other names: Transarterial Chemoembolisation, Transarterial Radioembolization, Bland Transarterial Embolization, Hepatic Vein Embollization, Portal Vein Embolization

Primary outcomes

  1. Progression free survival

    Time frame: Short term (3-6 months)

    Treatment Efficacy

  2. Progression free survival

    Time frame: From time of intervention up to 1 year (medium term)

  3. Progression free survival

    Time frame: From time of intervention up to 5 years (Long term)

  4. Residual hepatic volume

    Time frame: within 40 days of procedure

    Treatment Efficacy

Secondary outcomes

  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

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco De Cobelli, MD

CONTACT

[email protected]

+39022643 ext. 2529

Stephanie Steidler, PhD

CONTACT

[email protected]

+39022643 ext. 6111

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study 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

Acronym: LEATUM

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Feb 6, 2023
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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