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
Name | Hospital |
---|---|
Attila Kovács (Co-Chairperson) | MediClin Robert Janker Klinik/DE |
Philipp Wiggerman (Co-Chairperson) | Städtisches Klinikum Braunschweig gGmbH/DE |
Dirk Arnold | Asklepios Tumorzentrum Hamburg/DE |
Francois Cornelis | Memorial Sloan Kettering Cancer Center/US |
Guiseppe Curigliano | Istituto Europeo di Oncologia/IT |
Roberto Iezzi | Policlinico Universitario Agostino Gemelli/IT |
Michael Moche | Helios Park-Klinikum Leipzig/DE |
Franco Orsi | Istituto Europeo di Oncologia/IT |
Tze Wah | Leeds Teaching Hospitals NHS Trust/UK |
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
Name | Hospital |
---|---|
Phillipe L. Pereira (Co-Chairperson) | SLK Kliniken Heilbronn/DE |
Thierry de Baère (Co-Chairperson) | Institute Goustave Roussy/FR |
Reto Bale | Universitätsklinik Innsbruck/AT |
Åsmund A. Fretland | Oslo University Hospital/NO |
Nahum Goldberg | Hadassah Medical Center/IL |
Thomas Helmberger | Städtisches Klinikum München/DE |
Martijn Meijerink | VU Medisch Centrum/NL |
Franco Orsi | European Institute of Oncology Milan/IT |
Theo Ruers | Cancer Institute of Amsterdam/NL |
Stefan Stättner | Salzkammergut Klinikum Vöcklabruck/AT |
Thomas Vogl | Universitätsklinik Frankfurt/DE |
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
Name | Hospital |
---|---|
Philippe Pereira (Co-Chairperson) | SLK Heilbronn/DE |
Julien Taieb (Co-Chairperson) | Hôpital Georges-Pompidou/FR |
Dirk Arnold | Asklepios Klinik Altona /DE |
Patrick Chevallier | Chu de Nice/FR |
Thierry de Baère | Institut Gustave Roussy/FR |
Raúl García Marcos | Hospital Universitari i Politècnic La Fe/ES |
Fernando Gomez | Hospital Clínic de Barcelona/ES |
Thomas Helmberger | Städtisches Klinikum München/DE |
Roberto Iezzi | Policlinico Universitario Agostino Gemelli/IT |
Geert Maleux | UZ Leuven/BE |
Hassan Malik | Aintree University Hospital/GB |
Olivier Pellerin | Hôpital Georges-Pompidou/FR |
Simon Pernot | Hôpital Georges-Pompidou/FR |
Hans Prenen | UZ Antwerp/BE |
Bruno Sangro | Clinica 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
Name | Hospital |
---|---|
Valérie Vilgrain (Chairperson) | Hôpital Beaujon/FR |
Thomas Helmberger (Chairperson) | Klinikum Bogenhausen/DE |
Olivier Pellerin (National Coordinator) | Hôpital Européen Georges-Pompidou/FR |
Dirk Arnold | Asklepios Klinikum Hamburg/DE |
Geert Maleux | Universitair Ziekenhuis Leuven/BE |
Bora Peynircioglu | Hacettepe Üniversitesi Tıp Fakültesi/TR |
Bruno Sangro | Clínica Universidad de Navarra/ES |
Niklaus Schäfer | CHUV-Lausanne University Hospital/CH |
Maxime Ronot | Hôpital Beaujon/FR |
Romanic Loffroy | CHU de Dijon/FR |
Nathalie Kaufmann | CIRSE 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
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
Name | Hospital |
---|---|
Thomas Helmberger (Chairperson) | Klinikum Bogenhausen/DE |
Dirk Arnold | Asklepios Klinikum Hamburg/DE |
José Ignacio Bilbao | Clínica Universidad de Navarra/ES |
Roberto Cianni | Azienda Ospedaliera San Camillo Forlanini/IT |
Samer Ezziddin | Universitätsklinikum des Saarlandes/DE |
Frank Kolligs | Helios Klinikum Berlin-Buch/DE |
Geert Maleux | Universitair Ziekenhuis Leuven/BE |
Derek Manas | Freeman Hospital/GB |
Graham Munneke | University College London/GB |
Jean-Pierre Pelage | CHU de Caen/FR |
Olivier Pellerin | Hôpital Européen Georges-Pompidou/FR |
Bora Peynircioglu | Hacettepe Üniversitesi Tıp Fakültesi/TR |
Bruno Sangro | Clínica Universidad de Navarra/ES |
Niklaus Schäfer | CHUV-Lausanne University Hospital/CH |
Ian Haynes | non-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