Back to resultsIrreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
Primary Purpose
Pancreatic Adenocarcinoma, Interventional Imaging
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NanoKnife
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring Locally advanced pancreatic carcinoma, Irreversible electroporation, Interventional radiology
Eligibility Criteria
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
Sites / Locations
- CHU Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electrodes
Arm Description
Electrodes
Outcomes
Primary Outcome Measures
R0 resection rate
Assessment of the R0 resection (complete tumour removal with negative resection margins) rate of locally advanced pancreatic cancer treated by electroporation
Secondary Outcome Measures
Full Information
NCT ID
NCT03105921
First Posted
April 4, 2017
Last Updated
March 29, 2022
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03105921
Brief Title
Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
Official Title
Intérêt de l'électroporation irréversible Dans le Traitement de l'adénocarcinome du pancréas
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2014 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma, Interventional Imaging
Keywords
Locally advanced pancreatic carcinoma, Irreversible electroporation, Interventional radiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrodes
Arm Type
Experimental
Arm Description
Electrodes
Intervention Type
Device
Intervention Name(s)
NanoKnife
Intervention Description
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 Measure Information:
Title
R0 resection rate
Description
Assessment of the R0 resection (complete tumour removal with negative resection margins) rate of locally advanced pancreatic cancer treated by electroporation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
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