Actively Recruiting
Liver Embolization Approaches for Tumor Management - Retrospective and Prospective Analysis of Clinical Outcomes in Patients with Primary and Secondary Liver Tumors
Led by IRCCS San Raffaele · Updated on 2024-04-12
580
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the outcomes of different embolization techniques used to treat patients with primary and secondary liver tumors. This observational registry aims to assess short, medium, and long-term progression-free survival after embolization, as well as to evaluate residual liver volume in cases where the procedure is used to promote liver regeneration. The study includes patients treated as part of their usual clinical care without additional interventions. The procedure being observed is embolization, an endovascular treatment applied to patients with liver tumors. Participants will continue their normal treatment plans, and the study will not alter their therapeutic approach. The research focuses on tracking clinical outcomes over time following embolization procedures. Participants will be monitored through their regular clinical visits, with researchers collecting data on progression-free survival at intervals from 3 months up to 5 years after the procedure. Residual liver volume will be measured within 40 days post-treatment. Overall survival will also be assessed up to five years. The study involves no extra treatment or interventions beyond standard care, and data collection will follow the patients' usual medical schedules.
CONDITIONS
Brief Title
Liver Embolization Approaches for Tumor Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Patients with primary or secondary liver tumors not suitable for surgery or ablation
- Patients with liver tumors who are candidates for major surgery before liver hypertrophy induction
- Able and willing to sign informed consent
You will not qualify if you...
- Pregnant women
- Patients with uncorrectable bleeding disorders
- Patients with widespread disease outside the liver
- For lobar TACE and TARE: presence of bilodigestive shunt
- For TARE: hepatopulmonary shunt greater than 20%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus up to 40 days for assessment
Participants undergo embolization, an endovascular treatment for liver tumors.
1 procedure visit and follow-up visits within 40 days
Duration - Up to 5 years
Participants are monitored for progression free survival and overall survival after the embolization procedure.
Follow-up visits as scheduled up to 5 years
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
Research Team
F
Francesco De Cobelli, MD
S
Stephanie Steidler, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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