Registry on percutaneous electrochemotherapy

Recruiting

Conditions: C22
Malignant neoplasm of liver and intrahepatic bile ducts

Registration Number: DRKS00029619

Lead Sponsor: Cardiovascular and Interventional Radiological Society of Europe

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

none

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of RESPECT is to evaluate local tumor control in the liver at 12 months on a lesion-by-lesion basis. For this purpose, the size of lesions treated with pECT will be measured and their status will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).

Secondary Outcome Measures

Name	Time	Method
The secondary objectives of RESPECT are to further evaluate the efficacy of pECT in liver malignancies using additional parameters and/or longer time periods, and to evaluate the safety and impact on patient quality of life and pain. <br>Efficacy will be further evaluated based on disease progression and patient survival. <br>The safety of pECT will be evaluated based on the occurrence and severity of adverse events during the first three months using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. <br>Quality of life effects will be assessed using the European Organisation for Research and Treatment of CancerEuropean Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Data are analyzed according to the guidelines of the EORTC QLQ-C30 assessment manual. <br>Pain will also be recorded using a questionnaire specifically designed for RESPECT that includes questions to assess the severity, pathophysiology, and nature of pain before and after treatment.<br>