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Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study

Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06774690
Enrollment
3300
Registered
2025-01-14
Start date
2021-04-21
Completion date
2030-04-30
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma Cancer, HCC - Hepatocellular Carcinoma

Brief summary

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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Type and size of the injuryFrom enrollment to the end of treatment at 9 yearsType and size of the injury
Radiological response to therapyFrom enrollment to the end of treatment at 9 yearsRadiological response to therapy
Post treatment complicationsFrom enrollment to the end of treatment at 9 yearsPost treatment complications

Countries

Italy

Contacts

Primary ContactCristina Mosconi, MD
cristina.mosconi@aosp.bo.it0039 3498496325

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026