Liver Embolization Approaches for Tumor Management

NCT05714124 | Recruiting

• 1 other identifier: LEATUM
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

embolization, TAE, TACE, TARE, PVE, HVE

Outcome Measures

Primary Outcomes (4)

• Progression free survival

  Treatment Efficacy

  Short term (3-6 months)

• 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

  Treatment Efficacy

  within 40 days of procedure

Secondary Outcomes (1)

• Overall survival

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

Interventions

Embolization PROCEDURE

Endovascular treatment for patients with primary and secondary liver tumors

Also known as: Transarterial Chemoembolisation, Transarterial Radioembolization, Bland Transarterial Embolization, Hepatic Vein Embollization, Portal Vein Embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary or secondary liver tumors

You may qualify if:

• ≥ 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

You may not qualify if:

• pregnant women
• patients with uncorrectable coagulopathy
• diffuse extrahepatic disease
• for lobar TACE and TARE - presence of bilodigestive shunt
• for TARE - \>20% hepatopulmonary shunt

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma; Colonic Neoplasms; Neoplasm Metastasis; Stomach Neoplasms; Pancreatic Neoplasms

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Central Study Contacts

Francesco De Cobelli, MD

CONTACT

+39022643; trialcliniciradiologia@hsr.it

Stephanie Steidler, PhD

CONTACT

+39022643; steidler.stephanie@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiology

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 6, 2023
• Study Start: May 21, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

IT (1)