Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
Intérêt de l'électroporation irréversible Dans le Traitement de l'adénocarcinome du pancréas
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2014
CompletedFirst Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedMarch 31, 2022
March 1, 2022
6.4 years
April 4, 2017
March 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Electrodes
EXPERIMENTALElectrodes
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Poitiers
Poitiers, 86000, France
Related Publications (1)
Tasu JP, Herpe G, Damion J, Richer JP, Debeane B, Vionnet M, Rouleau L, Carretier M, Ferru A, Ingrand P, Tougeron D. Irreversible electroporation to bring initially unresectable locally advanced pancreatic adenocarcinoma to surgery: the IRECAP phase II study. Eur Radiol. 2024 Oct;34(10):6885-6895. doi: 10.1007/s00330-024-10613-x. Epub 2024 Mar 18.
PMID: 38494526DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 10, 2017
Study Start
October 24, 2014
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
March 31, 2022
Record last verified: 2022-03