Liver Embolization Approaches for Tumor Management

Recruiting

• Conditions: Cholangiocarcinoma; Metastatic Cancer; Metastatic Gastric Cancer; Metastatic Colon Cancer; Primary Liver Cancer; Metastatic Pancreatic Cancer; Hepatocellular Carcinoma

• Registration Number: NCT05714124
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-21
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2026-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 580

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy