Registry on Percutaneous Electrochemotherapy

NCT05267080 | Active Not Recruiting DMC

• 1 other identifier: RESPECT
• Study Type: observational
• Target: 250
• Locations: 7 countries
• Sites: 15

Brief Summary

The Registry on Percutaneous ElectroChemoTherapy (RESPECT) is a post-market, prospective, non-randomized, observational study aiming at evaluating the effectiveness of percutaneous electrochemotherapy (ECT) for the treatment of liver cancer.

Conditions

Primary Liver Cancer; Secondary Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Local Tumour Control

  Based on the tumour status according to mRECIST assessment

  12 months

Secondary Outcomes (9)

• Safety (in terms of adverse events related to treatment)

  12 months

• Tumour status (size)

  End of study (maximum 36 months)

• Tumour status (mRECIST)

  End of study (maximum 36 months)

• Quality of life (EORTC QLQ-C30)

  3 months

• Pain assessment

  1 month

Interventions

CLINIPORATOR DEVICE

The CLINIPORATOR is used to perform percutaneous electrochemotherapy on liver tumours.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary or secondary liver cancer referred to local ablative treatment by multidisciplinary tumour board and treated with pECT by decision of the interventional radiologist in charge.

You may qualify if:

• years or older
• Primary or secondary liver cancer
• Referral to local ablative treatment by multidisciplinary tumour board and decision to treat with pECT by interventional radiologist in charge
• Planned treatment with pECT using the CLINIPORATOR
• Signed informed consent form

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Cardiovascular and Interventional Radiological Society of Europe: lead

Study Sites (15)

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Location

Hôpital Européen Georges-Pompidou

Paris, France

Location

Institut Gustave Roussy

Paris, France

Location

WEGE Klinik

Bonn, Germany

Location

Städtisches Klinikum Braunschweig

Braunschweig, Germany

Location

Universitätsklinikum Halle

Halle, Germany

Location

Helios Park-Klinikum

Leipzig, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

University of Szeged

Szeged, Hungary

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy

Location

Policlinico Universitario A. Gemelli

Rome, Italy

Location

Vilnius University Hospital Santariškių Klinikos

Vilnius, Lithuania

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Philipp Wiggermann, Prof. Dr.

  Städtisches Klinikum Braunschweig, Braunschweig, Germany

  STUDY CHAIR

• Attila Kovács, PD. Dr. med.

  WEGE Klinik, Bonn, Germany

  STUDY CHAIR

• Franco Orsi, Prof.

  European Institute of Oncology, Milan, Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 4, 2022
• Study Start: January 25, 2023
• Primary Completion: January 23, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1); ES (1); IT (3); GB (1); FR (3); DE (5); HU (1)