Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma

Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105921
• Other study ID #: IRECAP
• Status: Completed
• Phase: N/A
• Start date: October 24, 2014
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2022
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Interventional Imaging
• Pancreatic Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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