Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma

Not Applicable

Completed

• Conditions: Pancreatic Adenocarcinoma; Interventional Imaging
• Interventions: Device: NanoKnife

• Registration Number: NCT03105921
• Lead Sponsor: Poitiers University Hospital

Brief Summary

The aim of the study is to evaluate the use of irreversible electroporation in the treatment of locally advanced cancers of the head of pancreas with vascular spread. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-24
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-10
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with histologically proven adenocarcinoma of the head of the pancreas (fine needle aspiration or biopsy)
• Pancreatic adenocarcinoma locally advanced on imaging at diagnosis
• Tumor of less than 7 cm in largest diameter
• No chemotherapy or abdominal radiotherapy within five years before the inclusion in the study

Exclusion Criteria

• Pancreatic adenocarcinoma of more than 7 cm of diameter or immediately operable on imaging data
• Patient with contraindication of NanoKnife use
• Patient with neurostimulator
• Epileptic patient or with a myocardial infarction lasting less than 2 months
• Presence of visceral or lymph node metastases or peritoneal carcinosis at the initial workup
• Patient who cannot be treated with muscle blockers (curare)
• Patient with a metallic stent or a medical device implanted near the area treated by electroporation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrodes	NanoKnife	Electrodes

Primary Outcome Measures

Name	Time	Method
R0 resection rate	3 months	Assessment of the R0 resection (complete tumour removal with negative resection margins) rate of locally advanced pancreatic cancer treated by electroporation

Trial Locations

Locations (1)

CHU Poitiers; 🇫🇷 Poitiers, France