Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-24

Study Completion Date

2021-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Adenocarcinoma Interventional Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electrodes

Group Type EXPERIMENTAL

NanoKnife

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No