Irreversible Electroporation for treatment of unresectable, locally advanced pancreatic cancer in the Leiden University Medical Center: a phase I/II study
- Conditions
- ocally advanced unresectable pancreatic cancer, alvleesklierkanker, lokaal uitgebreid
- Registration Number
- NL-OMON21164
- Lead Sponsor
- eiden University Medical Centre
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1.18 years of age;
2.Tumour in the pancreas suspected for adenocarcinoma;
Exclusion Criteria
1.Contraindications for laparotomy or IRE
2.Resectable at laparotomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and feasibility of the procedure. The safety is checked by reporting adverse events, also the first 5 procedures will be filmed. The feasibility is measured by evaluating specific questions about procedure and technical aspects. This is evaluated after every procedure.
- Secondary Outcome Measures
Name Time Method - Local progression free survival, based on CT scans. Once pre-procedural, than 5days after, 3,6,9,12,18,24 months after the procedure. <br /><br>- Overall survival in days - day of surgery untill day of death<br /><br>- Tumour downstaging/follow-up of local situation, based on repeated CT scans<br /><br>- NRS pain score; this will be measured daily post-operative. Outcomes will be compared with a control group of patients treated before this trial. <br /><br>- Hospital stay (days: form day of procedure till day of discharge)<br /><br>- Tumour response related to immune defence (blood samples). Once pre-procedural, than 5days after, 3,6,9,12,18,24 months after the procedure.<br /> <br>- Quality of life; as measured by EORTC questionnaire. Once pre-procedural, than 3,9, 18 months after the procedure.