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.

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Key information

Conditions

Pancreatic Adenocarcinoma Interventional Imaging

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NanoKnife

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.

Primary outcomes

R0 resection rate

Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2021
Study completion: 2021
First posted: Apr 10, 2017
Registry last updated: Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed