Cardiovascular and Interventional Radiological Society of Europe
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To guarantee independent and unbiased data collection and analysis requires the set-up of registries like RESPECT within independent scientific organisations such as CIRSE and Next Research.

RESPECT is a European-wide, prospective, observational (non-interventional) study that gathers data on percutaneous electrochemotherapy (ECT) in patients with primary and secondary liver cancer. The registry observes the real-life use of the CLINIPORATOR® device in the context of the patients’ entire cancer treatment and collects extensive data regarding effectiveness, safety and toxicity, and treatment-related quality of life. The collection of real-life data is intended to form an large, multi-centric evidence-base of the therapies’ untilisation to treat primary and secondary liver cancer.

RESPECT spans the continent and aims to enrol up to 250 patients over an initial period of two years and a minimum follow-up of 24 months. The first patient is projected to be included in September 2022.

Steering Committee

NameHospital
Attila Kovács (Co-Chairperson)MediClin Robert Janker Klinik/DE
Philipp Wiggerman (Co-Chairperson)Städtisches Klinikum Braunschweig gGmbH/DE
Dirk ArnoldAsklepios Tumorzentrum
Hamburg/DE
Francois CornelisMemorial Sloan Kettering Cancer Center/US
Guiseppe CuriglianoIstituto Europeo di Oncologia/IT
Roberto IezziPoliclinico Universitario Agostino Gemelli/IT
Michael MocheHelios Park-Klinikum Leipzig/DE
Franco OrsiIstituto Europeo di Oncologia/IT
Tze WahLeeds Teaching Hospitals NHS Trust/UK
With CIEMAR the society plans to close the existing gap in real-life evidence regarding percutaneous microwave ablation for the treatment of liver metastases.

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

NameHospital
Phillipe L. Pereira (Co-Chairperson)SLK Kliniken Heilbronn/DE
Thierry de Baère (Co-Chairperson)Institute Goustave Roussy/FR
Reto BaleUniversitätsklinik Innsbruck/AT
Åsmund A. FretlandOslo University Hospital/NO
Nahum GoldbergHadassah Medical Center/IL
Thomas HelmbergerStädtisches Klinikum München/DE
Martijn MeijerinkVU Medisch Centrum/NL
Franco OrsiEuropean Institute of Oncology Milan/IT
Theo RuersCancer Institute of Amsterdam/NL
Stefan StättnerSalzkammergut Klinikum Vöcklabruck/AT
Thomas VoglUniversitätsklinik Frankfurt/DE
CIREL will greatly contribute to the collection of scientific knowledge and clinical data in one of interventional radiology’s most dynamic and promising fields and help us understand better what could be the potential indications to treat patients with TACE.
CIREL was designed to provide real-life data for irinotecan-TACE for CRLM patients, a previously underexplored therapy with insufficient level of evidence. The collected data will increase the knowledge base for treating salvage therapy patients with limited treatment options and explore the potential for the use in earlier stages of the cancer continuum care.

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

NameHospital
Philippe Pereira (Co-Chairperson)SLK Heilbronn/DE
Julien Taieb (Co-Chairperson)Hôpital Georges-Pompidou/FR
Dirk ArnoldAsklepios Klinik Altona /DE
Patrick ChevallierChu de Nice/FR
Thierry de BaèreInstitut Gustave Roussy/FR
Raúl García MarcosHospital Universitari i Politècnic La Fe/ES
Fernando GomezHospital Clínic de Barcelona/ES
Thomas HelmbergerStädtisches Klinikum München/DE
Roberto IezziPoliclinico Universitario Agostino Gemelli/IT
Geert MaleuxUZ Leuven/BE
Hassan MalikAintree University Hospital/GB
Olivier PellerinHôpital Georges-Pompidou/FR
Simon PernotHôpital Georges-Pompidou/FR
Hans PrenenUZ Antwerp/BE
Bruno SangroClinica Universidad de Navarra/ES

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

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

NameHospital
Valérie Vilgrain (Chairperson)Hôpital Beaujon/FR
Thomas Helmberger (Chairperson)Klinikum Bogenhausen/DE
Olivier Pellerin (National Coordinator)Hôpital Européen Georges-Pompidou/FR
Dirk ArnoldAsklepios Klinikum Hamburg/DE
Geert MaleuxUniversitair Ziekenhuis Leuven/BE
Bora PeynirciogluHacettepe Üniversitesi Tıp Fakültesi/TR
Bruno SangroClínica Universidad de Navarra/ES
Niklaus SchäferCHUV-Lausanne University Hospital/CH
Maxime RonotHôpital Beaujon/FR
Romanic LoffroyCHU de Dijon/FR
Nathalie KaufmannCIRSE Office

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

With more that 1,000 recruited patients it will be possible to get a good picture of how radioembolisation is being performed in Europe.

The CIRSE Registry for SIR-Spheres Therapy (CIRT) was a European-wide prospective observational study on the clinical application and outcomes of radioembolisation with SIR-Spheres therapy. It was initiated in 2014 as a result of the lack of clinical data on the use of SIR-Spheres in the real-life context and was the first study to be completely sponsored and executed by the CIRSE Society. Over a period of 3 years, more than 1000 patients with primary and metastatic liver cancer were included in the study and were followed-up for at least 24 months, whereby data on survival, adverse events and quality of life have been collected.

The first data publication came out in 2020 (see below) and further indication-specific analyses are currently being performed. The CIRT Steering Committee is thrilled to share these outcomes with the IR community and the medical community as a whole.

Steering Committee

NameHospital
Thomas Helmberger (Chairperson)Klinikum Bogenhausen/DE
Dirk ArnoldAsklepios Klinikum Hamburg/DE
José Ignacio BilbaoClínica Universidad de Navarra/ES
Roberto CianniAzienda Ospedaliera San Camillo Forlanini/IT
Samer EzziddinUniversitätsklinikum des Saarlandes/DE
Frank KolligsHelios Klinikum Berlin-Buch/DE
Geert MaleuxUniversitair Ziekenhuis Leuven/BE
Derek ManasFreeman Hospital/GB
Graham MunnekeUniversity College London/GB
Jean-Pierre PelageCHU de Caen/FR
Olivier PellerinHôpital Européen Georges-Pompidou/FR
Bora PeynirciogluHacettepe Üniversitesi Tıp Fakültesi/TR
Bruno SangroClínica Universidad de Navarra/ES
Niklaus SchäferCHUV-Lausanne University Hospital/CH
Ian Haynesnon-voting representative from Sirtex Medical

Publications

Helmberger T, Arnold D, Bilbao JI, de Jong N, Maleux G, Nordlund A, Peynircioglu B, Sangro B, Sharma RA, Walk A, Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study, JMIR Res Protoc 2020;9(4):e16296, DOI: 10.2196/16296, PMID: 32319960.

Helmberger, T, Golfieri, R, Pech, M, et al. Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT). Cardiovasc Intervent Radiol (2020). DOI: 10.1007/soo270-020-02642-y, PMID: 32959085