REgiStry for Percutaneous ElectroChemoTherapy
Status: enrolling
RESPECT
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.
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 2026. After patient enrolment is complete, another year will be used for data collection of enrolled patients to reach the planned follow-ups.
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
| Name | Hospital | ||
|---|---|---|---|
| Attila Kovács (Co-Chairperson) | WEGE Klinik/DE | ||
| Philipp Wiggermann (Co-Chairperson) | Städtisches Klinikum Braunschweig gGmbH/DE | ||
| Franco Orsi (Co-Chairperson) | Istituto Europeo di Oncologia/IT | ||
| 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 | ||
| Tze Wah | Leeds Teaching Hospitals NHS Trust/UK | ||