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

Recruiting

• Conditions: HCC - Hepatocellular Carcinoma; Cholangiocarcinoma Cancer

• Registration Number: NCT06774690
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2021-04-21
• Status Verified: 2024-10
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2030-03
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type and size of the injury	From enrollment to the end of treatment at 9 years	Type and size of the injury
Radiological response to therapy	From enrollment to the end of treatment at 9 years	Radiological response to therapy
Post treatment complications	From enrollment to the end of treatment at 9 years	Post treatment complications

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy