Irreversible Electroporation (NanoKnife) For The Treatment Of Pancreatic Adenocarcinoma

Study Overview

Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma

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.

N/A

Pancreatic Adenocarcinoma
Interventional Imaging

DEVICE: NanoKnife

IRECAP

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-04-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-03-29
First Submitted that Met QC Criteria 2017-04-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-03-31
First Posted (ACTUAL) 2017-04-10	Results First Posted N/A	Last Verified 2022-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Electrodes Electrodes	DEVICE: NanoKnife The aim of the treatment is to sourround the tumour with two to six needles and to deliver a very high voltage current (3000 volts in 70 to 80 microseconds pulses) by a generator synchronized with an electrocardiogram.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Electrodes

Electrodes

DEVICE: NanoKnife

The aim of the treatment is to sourround the tumour with two to six needles and to deliver a very high voltage current (3000 volts in 70 to 80 microseconds pulses) by a generator synchronized with an electrocardiogram.

Primary Outcome Measures	Measure Description	Time Frame
R0 resection rate	Assessment of the R0 resection (complete tumour removal with negative resection margins) rate of locally advanced pancreatic cancer treated by electroporation	3 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Tasu JP, Herpe G, Damion J, Richer JP, Debeane B, Vionnet M, Rouleau L, Carretier M, Ferru A, Ingrand P, Tougeron D. Irreversible electroporation to bring initially unresectable locally advanced pancreatic adenocarcinoma to surgery: the IRECAP phase II study. Eur Radiol. 2024 Oct;34(10):6885-6895. doi: 10.1007/s00330-024-10613-x. Epub 2024 Mar 18.

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Resources

PatientS

Caregivers

Clinical Trial Record