Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HCC - Hepatocellular Carcinoma, Cholangiocarcinoma Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to learn what are the best conditions that will give a positive outcome to men and women that receive a intra arterial therapy (IAT) for primary liver cancer. Intra arterial therapies are radiologic procedures that block liver cancer blood supply. The researchers will collect the data of participants located in the Radiology department in "IRCCS Azienda Ospedaliera Universitaria" Hospital in Bologna and will study clinic and radiological traits to understand which is the best case scenario for a optimal treatment response.
Detailed description
This study is non profit, observational, retrospective, prospective and single institution.
The researchers will do a retrospective and prospective data collection and analyze the results. They will examine the radiological images (CT scan and RM) to assess the type and size of the cancer, track how the disease responds to treatments, identify possible complications.
There are no drugs involved and all the intra arterial therapies are performed within the routine clinical-care path.
* For the retrospective phase the researchers will analyze radiological image of the participants that received a intra arterial therapy from the 1st of January 2009. It's expected to enroll around 2000 participants. * For the prospective phase the researchers will enroll for 5 years eligible participants that will receive a intra arterial therapy. Participants will go through a follow up every three months for the duration of the whole study. It is expected to enroll around 1300 participants.
Primary outcome measures
- Type and size of the injury [Time frame: From enrollment to the end of treatment at 9 years]
- Radiological response to therapy [Time frame: From enrollment to the end of treatment at 9 years]
- Post treatment complications [Time frame: From enrollment to the end of treatment at 9 years]
Eligibility criteria
Inclusion criteria
- diagnosis of Hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA) and clinical indication to receive or have already received one of the following treatments:
- Trans-arterial embolization (TAE),
- Transarterial chemoembolization (TACE),
- Transarterial radioembolization (TARE)
- Drug-eluting beads chemoembolization (DEB-TACE)
- Age over 18
- To give informed consent
Exclusion criteria
- shunt of gastro intestinal arteries that cannot be embolized
- metastasis spread outside of the liver
- liver failure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06774690 · IAT for liver cancer