27

The CIRSE Registry for LifePearl Microspheres (CIREL)

New techniques of transcatheter chemo-embolisation (TACE) with drug-eluting beads have been developed in the last 10 years for treating patients affected by colorectal adenocarcinoma with metastatic disease. Chemo-embolisation with Irinotecan-eluting beads is a relatively novel treatment modality, which has been proven efficient and safe, but more evidence in a clinical setting is necessary. In order to address this need, CIRSE will shortly launch the CIRSE Registry for LifePearl Microspheres (CIREL).

CIREL will prospectively capture the broadest feasible spectrum of data on the delivery of transcatheter arterial chemoembolization (TACE) using beads loaded with Irinotecan (LP-IRI) and related clinical outcomes throughout Europe. The aim of doing so is to improve our understanding of how these beads are administered as part of the standard treatment of colorectal adenocarcinoma with liver-only or liver-dominant metastases.

Ultimately, the collection of real-life data is intended to form an evidence-base from which conclusions can be drawn on how to improve patient care and further optimise treatment protocols and consequently also therapy outcomes. CIREL will be collecting data over an initial period of three years following enrolment of the first patient, by mid-2017.

CIREL is governed by a multidisciplinary Steering Committee, which is composed of leading experts from the fields of interventional radiology, oncology, surgery and hepatology. The Committee is co-chaired by the coordinating investigators, Prof. Philippe L. Pereira (Director Clinic of Radiology, Minimally Invasive Therapies and Nuclear Medicine SLK Clinics, Heilbronn, Germany) and Prof. Julien Taieb (Head of Hepato-Gastroenterology and Digestive Oncology, Hôpital Européen Georges Pompidou, Paris, France).

CIREL Steering Committee  
Philippe Pereira Co-Chairperson, Interventional Radiology, Heilbronn/DE
Julien Taieb Co-Chairperson, Oncology, Paris/FR
Dirk Arnold Oncology, Lisboa/PT
Patrick Chevallier Interventional Radiology, Nice/FR
Thierry De Baère Interventional Radiology, Paris/FR
Raúl García Marcos Interventional Radiology, Valencia/ES
Fernando Gomez Muñoz Interventional Radiology, Barcelona/ES
Thomas Helmberger Interventional Radiology, Munich/DE
Geert Maleux Interventional Radiology, Leuven/BE
Hassan Malik Surgery, Liverpool/UK
José Martinez Interventional Radiology, Valencia/ES
Olivier Pellerin Interventional Radiology, Paris/FR
Simon Pernot Oncology, Paris/FR
Hans Prenen Oncology, Leuven/BE
Bruno Sangro Hepatology, Pamplona/ES
Vladimir Borovicanin Non-voting member from Terumo Europe

 

Objectives:

The primary objective of the registry is to prospectively capture clinical treatment data to map exactly at which stage in treatment the device is being applied, and to assign the real-life practice of LifePearl Microspheres to different categories (including first-line, consolidation, intensification and end-stage treatment).

The secondary objective of CIREL is the assessment of observed treatment outcomes in terms of safety and effectiveness, quality of life as well as the determination of predictive response factors where possible.

  LifePearl Microspheres Syringe

Methods:

Data will be collected prospectively from medical centres throughout Europe via an electronic data capture (EDC) system. A certain level of experience with TACE will be required from participating centres in order to exclude operators that are still in the learning phase of the procedure.  The registry is planned to run for a minimum of three years following enrolment of the first patient.

In addition to the data collection via the online ECD system, a central image analysis will be performed by an independent institute in France, which will provide a second assessment of three MR or CT images per patient. 

Finally, to measure the impact of the treatment on patients’ quality of life, the Steering Committee decided to include a patient questionnaire developed by the experts at the European Organisation for Research and Treatment of Cancer (EORTC): the QLQ-C30, a multilingually verified quality of life questionnaire.

 

If you have any further questions, please contact the CIRSE Clinical Research Department at research@cirse.org.