Evaluating liver embolization techniques for tumor management
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
IRCCS San Raffaele · NCT05714124
This study tests different liver embolization methods to see how well they help people with liver tumors live longer and maintain liver function while they continue their usual treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 580 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT05714124 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the short, medium, and long-term outcomes of various embolization techniques in patients with primary and secondary liver tumors. It focuses on assessing progression-free survival following embolization and the residual hepatic volume in cases where these techniques are used to promote liver regeneration. Patients will continue their standard treatment protocols without any additional interventions specific to the study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with primary or secondary liver tumors that are not suitable for surgery or ablation.
Not a fit: Patients with diffuse extrahepatic disease or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective embolization techniques for managing liver tumors, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored embolization techniques for liver tumors, indicating a growing body of evidence, though this specific observational approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan
- IRCCS Ospedale San Raffaele — Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Francesco De Cobelli, MD
- Email: trialcliniciradiologia@hsr.it
- Phone: +39022643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma, Cholangiocarcinoma, Metastatic Colon Cancer, Metastatic Cancer, Metastatic Gastric Cancer, Primary Liver Cancer, Metastatic Pancreatic Cancer, embolization, TAE, TACE, TARE, PVE, HVE