Pancreatic CancerIRE MargNCT02952859
Impact of Margin-accentuation IRE in Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Pancreatic cancer is the fourth leading cause of cancer deaths overall and second after colon and rectum cancer among gastrointestinal cancers in Western countries. In Switzerland, 1,172 new pancreatic cancer patients were diagnosed in 2012. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Irreversible electroporation
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2017to 25 Feb 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with potentially resectable and borderline resectable pancreatic cancer
Who may be able to join
- Patients with histology proven or highly suspected potentially resectable or borderline resectable pancreatic cancer will be included.
- Age ≥ 18 years
- Able to undergo general anesthesia (ASA ≤ 3)
- Performance status ECOG <=2 (Eastern Cooperative Oncology Group)
- Life expectancy of at least 6 months
- Resectable or borderline resectable proven pancreatic adenocarcinoma of the pancreas
Who cannot join
- Cardiac conduction abnormalities (AV conduction abnormalities)
- History of epilepsy
- Recent history of myocardial infarction (2 months)
- Evidence of distant metastasis (e.g. liver, lung, peritoneum)
- Informed consent cannot be given by the patient
- Known hypersensitivity to the IRE electrodes (stainless steel 304L)
- Women of childbearing potential who are pregnant, breast feeding, or not taking an adequate method of contraception at the time of procedure
Trial locations and contacts
1 site in 1 country.
About this study
Pancreatic cancer is the fourth leading cause of cancer deaths overall and second after colon and rectum cancer among gastrointestinal cancers in Western countries. In Switzerland, 1,172 new pancreatic cancer patients were diagnosed in 2012. Unfortunately, only about 20% of pancreatic cancer patients present at a disease state that allows surgical resection while 30% have locally advanced, unresectable disease and 50% show distant metastases. While the latter two are currently treated in a palliative setting with median survival of at most 6-12 months, patients who undergo tumor resection with curative intentions also achieve only 5-year survival rates of 20-25% in best hands. The reasons for this poor outcome are thought to be chemoresistance, early establishment of metastatic disease, and importantly, high rates of R1 resections. Up to 80% of pancreatic resections have positive resection margins which are often found within the vascular groove and/or at the retroperitoneal margin, close to the superior mesenteric artery. This high rate of positive margins is only found after meticulous pathological work-up and is normally not detected after standard assessment of the specimen. However, the clinical importance of the high positivity of resection margin is even more highlighted as patients undergoing portal vein resection despite negativity of portal vein invasion after regular pathological work-up show significantly better survival compared to patients without portal vein resection. In sum, given the overall poor prognosis despite tumor resection, auxiliary treatment strategies to improve long-term outcomes are desperately needed. Over the last 5 years, irreversible electroporation (IRE) emerged as a non-thermal ablative modality that allows local tumor destruction with sparing vital structures like arteries, venous vessels, as well as the bile and pancreatic duct. There is increasing evidence that IRE for locally unresectable pancreatic cancer is effective with an increase in local progression free survival , distant progression free survival and overall survival compared to historic controls.Data on margin accentuation IRE are sparse while in a recent study published by Martin et al showed that margin accentuation among patients with borderline resectable disease can be performed safe and efficacious if the treatment can be performed "with a high degree of technical ability and skill set".
- Conditions
- Pancreatic Cancer
- Being tested
- Irreversible electroporation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible electroporationOther
| Study group | Role | What they receive |
|---|---|---|
| historic control group | Work-up and follow-up of the historic control will be performed through similar means by contacting primary care physicians and/or medical oncologists, if information cannot be received, the patient will be directly contacted. In case the patient cannot be reached and no other information can be received on patients outcome, the death registry will be contacted. | |
| comparator group | All patients with potentially and borderline resectable pancreatic cancer are potentially candidates for IRE and will be considered for this treatment. Patient will be recruited/referred through daily clinical practice from the Inselspital Bern. Final inclusion into the study will be performed by the responsible investigators at the Inselspital Bern. Patients will be included according to the inclusion/exclusion criteria mentioned. Receives: Other: Irreversible electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from diagnosis to death for any reason
Postoperative complications
Measured: 6 weeks
Time from diagnosis to death for any reason
Local and distal recurrence, cancer specific survival
Measured: 3 months
Time from diagnosis to death for any reason
Local and distal recurrence, cancer specific survival
Measured: 6 months
Time from diagnosis to death for any reason
Local and distal recurrence, cancer specific survival
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startJan 2017
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Why it stopped: PI left hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Worni, MD, Principal investigator, Inselspital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952859
- Sponsor's protocol ID
- IRE Marg
- Acronym
- IRE Marg
- Status last verified
- Feb 2020
- First submitted
- 31 Oct 2016
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Margin-accentuation IRE in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02952859
- Acronym / sponsor ID
- IRE Marg / IRE Marg
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left hospital
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 2 Nov 2016 (estimated)
- 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.
Pancreatic cancer is the fourth leading cause of cancer deaths overall and second after colon and rectum cancer among gastrointestinal cancers in Western countries. In Switzerland, 1,172 new pancreatic cancer patients were diagnosed in 2012. Unfortunately, only about 20% of pancreatic cancer patients present at a disease state that allows surgical resection while 30% have locally advanced, unresectable disease and 50% show distant metastases. While the latter two are currently treated in a palliative setting with median survival of at most 6-12 months, patients who undergo tumor resection with curative intentions also achieve only 5-year survival rates of 20-25% in best hands. The reasons for this poor outcome are thought to be chemoresistance, early establishment of metastatic disease, and importantly, high rates of R1 resections. Up to 80% of pancreatic resections have positive resection margins which are often found within the vascular groove and/or at the retroperitoneal margin, close to the superior mesenteric artery. This high rate of positive margins is only found after meticulous pathological work-up and is normally not detected after standard assessment of the specimen. However, the clinical importance of the high positivity of resection margin is even more highlighted as patients undergoing portal vein resection despite negativity of portal vein invasion after regular pathological work-up show significantly better survival compared to patients without portal vein resection. In sum, given the overall poor prognosis despite tumor resection, auxiliary treatment strategies to improve long-term outcomes are desperately needed. Over the last 5 years, irreversible electroporation (IRE) emerged as a non-thermal ablative modality that allows local tumor destruction with sparing vital structures like arteries, venous vessels, as well as the bile and pancreatic duct. There is increasing evidence that IRE for locally unresectable pancreatic cancer is effective with an increase in local progression free survival , distant progression free survival and overall survival compared to historic controls.Data on margin accentuation IRE are sparse while in a recent study published by Martin et al showed that margin accentuation among patients with borderline resectable disease can be performed safe and efficacious if the treatment can be performed "with a high degree of technical ability and skill set".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| historic control group | – | –Work-up and follow-up of the historic control will be performed through similar means by contacting primary care physicians and/or medical oncologists, if information cannot be received, the patient will be directly contacted. In case the patient cannot be reached and no other information can be received on patients outcome, the death registry will be contacted. |
| comparator group | – | Other: Irreversible electroporationAll patients with potentially and borderline resectable pancreatic cancer are potentially candidates for IRE and will be considered for this treatment. Patient will be recruited/referred through daily clinical practice from the Inselspital Bern. Final inclusion into the study will be performed by the responsible investigators at the Inselspital Bern. Patients will be included according to the inclusion/exclusion criteria mentioned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with potentially resectable and borderline resectable pancreatic cancer
Key inclusion criteria (6 listed)
- Patients with histology proven or highly suspected potentially resectable or borderline resectable pancreatic cancer will be included.
- Age ≥ 18 years
- Able to undergo general anesthesia (ASA ≤ 3)
- Performance status ECOG <=2 (Eastern Cooperative Oncology Group)
- Life expectancy of at least 6 months
Key exclusion criteria (7 listed)
- Cardiac conduction abnormalities (AV conduction abnormalities)
- History of epilepsy
- Recent history of myocardial infarction (2 months)
- Evidence of distant metastasis (e.g. liver, lung, peritoneum)
- Informed consent cannot be given by the patient
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 |
|---|---|---|
| Irreversible electroporation | Other | comparator group |
Primary outcome
Time from diagnosis to death for any reason
Time frame: 6 weeks
Postoperative complications
Time from diagnosis to death for any reason
Time frame: 3 months
Local and distal recurrence, cancer specific survival
Time from diagnosis to death for any reason
Time frame: 6 months
Local and distal recurrence, cancer specific survival
Time from diagnosis to death for any reason
Time frame: 9 months
Local and distal recurrence, cancer specific survival
Results and safety
The study was stopped early (reason given: PI left hospital). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
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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.
Mathias Worni, MD principal investigator
Inselspital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 6 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: stopped early, as of the sponsor's last update on 26 Feb 2020. 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 Switzerland. 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 was stopped early (reason given: PI left hospital). Results are not available in the source record.
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?
Time from diagnosis to death for any reason (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2020.