Pancreatic AdenocarcinomaNCT03105921
Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
A study testing NanoKnife in people with Pancreatic Adenocarcinoma and Interventional Imaging, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Adenocarcinoma, Interventional Imaging
- What is being tested?
- NanoKnife
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2014to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intérêt de l'électroporation irréversible Dans le Traitement de l'adénocarcinome du pancréas
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.
- Conditions
- Pancreatic Adenocarcinoma, Interventional Imaging
- Being tested
- NanoKnife
- Keywords
- Locally advanced pancreatic carcinoma, Irreversible electroporation, Interventional radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoKnifeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrodes | Experimental | Electrodes Receives: Device: NanoKnife |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Assessment of the R0 resection (complete tumour removal with negative resection margins) rate of locally advanced pancreatic cancer treated by electroporation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start24 Oct 2014
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105921
- Sponsor's protocol ID
- IRECAP
- Status last verified
- Mar 2022
- First submitted
- 4 Apr 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38494526
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt de l'électroporation irréversible Dans le Traitement de l'adénocarcinome du pancréas
- ClinicalTrials.gov ID
- NCT03105921
- Acronym / sponsor ID
- IRECAP
- Conditions
- Pancreatic Adenocarcinoma, Interventional Imaging
- Keywords
- Locally advanced pancreatic carcinoma, Irreversible electroporation, Interventional radiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 24 Oct 2014 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrodes | Experimental | Device: NanoKnifeElectrodes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoKnifeThe 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. | Device | Electrodes |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 38494526Tasu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NanoKnife in people with Pancreatic Adenocarcinoma and Interventional Imaging, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.