Assessing optimal treatment settings for the ablation of locally advanced pancreatic cancer with CT-guided percutaneous irreversible electroporation: a randomized feasibility study.

Phase 2

Completed

Conditions: Locally advanced pancreatic cancer
10027656
pancreatic adenocarcinoma.
10017998

Registration Number: NL-OMON55702

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Age >=18 years
- LAPC (either primary or tumour recurrence following resection)
- At least RECIST stable disease after 2 months of chemotherapy with FOLFIRINOX
- Capable of providing written and oral informed consent
- Candidate for IRE, maximum diameter LAPC 5cm

Exclusion Criteria

- Participation in PELICAN trial focussing on radiofrequency ablation for LAPC
- Eligibility for resection
- Bleeding disorders which can not be corrected with medication
- Inability/unwillingness to interrupt anticoagulation therapy
- WHO 2/3 or ASA 3/4
- ICD/pacemaker
- Both partial stenosis of the portal vein and hepatic artery of >50%
- Pregnancy
- Metastatic pancreatic cancer

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility of CT-guided IRE. Primary outcomes after treatment are adverse<br /><br>events and serious adverse events (defined as CTCAE grade >=3 complications),<br /><br>which should not exceed 60%. Mortality should be below 5%. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are thermal injury, treatment duration, overall survival,<br /><br>progression-free survival, difference in serum CA19-9 (area under the curve)<br /><br>during the first 3 months post-IRE, temperature measurements in the treated<br /><br>region during IRE procedure, extent of the ablation zone and treatment efficacy<br /><br>on cross-sectional imaging (CT) 6 and 12 weeks after the procedure,<br /><br>post-intervention serum levels of amylase, lipase, glucose and transaminases,<br /><br>pain score (VAS) and analgesics use during the first three months post-IRE,<br /><br>systemic inflammatory response and continuation of chemotherapy following IRE. </p><br>