CIEMAR

CIRSE Emprint Microwave Ablation Registry

Status: enrolling

CIEMAR is a European-wide, prospective, observational (non-interventional) study that is gathering data on microwave ablation of colorectal liver metastases using the Emprint or Emprint HP microwave ablation device. Microwave tumour ablation provides a minimally invasive, potentially curative treatment option for various neoplasms and has been in use for over 15 years. The safety and efficacy of CRLM ablation has been demonstrated in randomised trials but large and prospective real-life data on effectiveness of microwave ablation is still lacking.

Data is being collected prospectively from medical centres throughout Europe via an electronic data capture (EDC) system. The primary objective is to assess the effectiveness of microwave ablation performed with the Emprint or Emprint HP device in controlling colorectal metastatic tumours in the liver.

CIEMAR has been approved to collect data on the Emprint HP device which will be submitted as post-market clinical follow-up data under MDR by the relevant notified body.

The CIRSE Emprint Microwave Ablation Registry is funded by a grant provided by Medtronic.

Steering Committee

CIREL

CIRSE REgistry for LifePearl Microspheres

Status: closed

CIREL is a European-wide, prospective, observational (non-interventional) study collecting data on transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded with irinotecan (LP-irinotecan TACE) in patients with colorectal cancer with liver metastatic disease (CRLM). 80% of CRLM patients have disease that cannot be curatively treated with surgery.

LP-irinotecan TACE works by blocking the blood supply to the liver metastases and by locally eluting the chemotherapeutic drug irinotecan. It is an interventional oncological procedure that has been shown to be a safe and effective option for CRLM patients. CIREL observes the real-life use of the procedure in the context of the patients’ entire cancer treatment and collects extensive data regarding safety and toxicity, efficacy and treatment-related quality of life. The collection of real-life data is intended to form an evidence-base from which conclusions can be drawn on how to improve patient selection and optimise treatment protocols to ultimately improve the therapy outcome of patients treated with LP-irinotecan TACE.

CIREL has published a paper on the prospective study methodology, as well as a 50-patient interim analysis and has now CIREL has entered the data collection close-out phase. With 152 enrolled patients and up to 4 years of follow-up, CIREL will not only create an important dataset that could greatly impact patient selection in TACE but also may stimulate further research into interventional oncological procedures.

Steering Committee

Publications

Pereira PL, Arnold D, de Baère T, Gomez F, Helmberger T, Iezzi R, Maleux G, Prenen H, Sangro B, Nordlund A, Zeka B, Bauer R, Kaufmann N, Pellerin O, Taieb J. A multicentre, international, observational study on transarterial chemoembolisation in colorectal cancer liver metastases: Design and rationale of CIREL. Dig Liver Dis. 2020 Aug;52(8):857-861. DOI: 10.1016/j.dld.2020.05.051, PMID: 32620520

Pereira, P.L., Iezzi, R., Manfredi, R. et al. The CIREL Cohort: A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis. Cardiovasc Intervent Radiol (2020). DOI: 10.1007/s00270-020-02646-8, PMID 32974773

CIRT-FR

CIRSE Registry for SIR-Spheres Therapy in FRance

Status: in follow-up

Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

Due to their expertise and experience with the European-wide observational study CIRT (CIRSE Registry for SIR-Spheres Therapy), the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), was offered to independently initiate the CIRSE Registry for SIR-Spheres Therapy in France (CIRT-FR).

Steering Committee

Publications

Loffroy, R., Ronot, M., Greget, M. et al. Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France. Cardiovasc Intervent Radiol (2020). DOI: 10.007/s00270-020-02643-x, PMID: 32975600