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Trial Title:
Liver Embolization Approaches for Tumor Management
NCT ID:
NCT05714124
Condition:
Hepatocellular Carcinoma
Cholangiocarcinoma
Metastatic Colon Cancer
Metastatic Cancer
Metastatic Gastric Cancer
Primary Liver Cancer
Metastatic Pancreatic Cancer
Conditions: Official terms:
Cholangiocarcinoma
Conditions: Keywords:
embolization, TAE, TACE, TARE, PVE, HVE
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Procedure
Intervention name:
Embolization
Description:
Endovascular treatment for patients with primary and secondary liver tumors
Other name:
Transarterial Chemoembolisation
Other name:
Transarterial Radioembolization
Other name:
Bland Transarterial Embolization
Other name:
Hepatic Vein Embollization
Other name:
Portal Vein Embolization
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.
Criteria for eligibility:
Study pop:
Patients with primary or secondary liver tumors
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Ospedale San Raffaele
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco De Cobelli, MD
Phone:
+39022643
Phone ext:
2529
Email:
trialcliniciradiologia@hsr.it
Contact backup:
Last name:
Stephanie Steidler, PhD
Phone:
+39022643
Phone ext:
6111
Email:
steidler.stephanie@hsr.it
Investigator:
Last name:
Francesco De Cobelli, MD
Email:
Principal Investigator
Investigator:
Last name:
Angelo Della Corte, MD
Email:
Sub-Investigator
Start date:
May 21, 2021
Completion date:
December 31, 2031
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714124