Behandeling met het Nanoknife® systeem bij patiënten met alvleesklierkanker die niet operatief verwijderd kan worde

Recruiting

• Conditions: Pancreatic cancer; locally advanced pancreatic cancer; LAPC

• Registration Number: NL-OMON29184
• Lead Sponsor: Academic Medical Center Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Age ≥18 years

- LAPC (either primary or tumour recurrence following resection), defined by the DPCG consensus criteria as: arterial involvement >90 or venous involvement >270)

Exclusion Criteria

- Participation in the PELICAN trial focussing on radiofrequency ablation for LAPC*

- Eligibility for resection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is treatment time of CT-guided IRE.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are toxicity/side effects, thermal injury overall survival, progression-free survival, difference in serum CA19-9 values (area under the curve) pre-and post-treatment, temperature measurements in the treated region during the IRE procedure, extent of the ablation zone and treatment efficacy on crosssectional<br>imaging (CT), peri-operative serum levels of lipase, amylase, glucose and transaminases, pain<br>scores/analgesics use during the first three months post IRE and continuation of chemotherapy following IRE ablation.