Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma

Intérêt de l'électroporation irréversible Dans le Traitement de l'adénocarcinome du pancréas

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03105921

Enrollment

Registered

2017-04-10

Start date

2014-10-24

Completion date

2021-04-01

Last updated

2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interventional Imaging, Pancreatic Adenocarcinoma

Keywords

Locally advanced pancreatic carcinoma, Irreversible electroporation, Interventional radiology

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.

Interventions

DEVICENanoKnife

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026