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RESPECT

REgiStry for Percutaneous ElectroChemoTherapy

Status: enrolling

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.
While I am convinced of the performance of percutaneous ECT, RESPECT is important as it will embed the therapy in evidence-based knowledge, in the overall context of all other interventional oncology procedures.

Study summary

RESPECT is a European-wide, prospective, observational cohort study collecting data from patients with primary or secondary liver cancer treated by percutaneous electrochemotherapy (pECT) using the CLINIPORATOR® device (IGEA, Carpi, Italy).

pECT is a minimally invasive treatment option that combines the use of a chemotherapeutic agent with reversible electroporation at the site of the tumour to potentiate local cytotoxicity. As it has very little impact on surrounding tissues, it is particularly adapted for the treatment of tumours in complicated locations.

The objectives of RESPECT are to assess the effectiveness of pECT in controlling liver malignancies, and to evaluate the safety of the procedure as well as its impact on patients’ survival, quality of life and pain.

With the first patient enrolled in January 2023, RESPECT aims to reach a total number of 250 participants before the end of the recruitment phase in January 2025. Enrolled patients will be followed-up for a maximum period of three years.

RESPECT is funded by an independent research grant provided by IGEA.

Endpoints

Primary objective

  • To assess the effectiveness of percutaneous ECT performed with the CLINIPORATOR® device in controlling primary and secondary liver cancer.

Primary endpoint

  • Local tumour control 12 months after treatment on a per lesion basis

Secondary endpoints

  • Safety
  • Overall survival / Progression-free survival
  • Quality of Life
  • Pain

Steering Committee

NameHospital
Attila Kovács (Co-Chairperson)MediClin Robert Janker Klinik/DE
Philipp Wiggermann (Co-Chairperson)Städtisches Klinikum Braunschweig gGmbH/DE
Dirk Arnold
Asklepios Tumorzentrum
Hamburg/DE
Francois CornelisMemorial Sloan Kettering Cancer Center/US
Giuseppe 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