AzTrials
AzTrials

Pancreatic Adenocarcinoma ResectableNCT03337997

A Pilot Study of IRE for Resectable Pancreatic Cancer

A study testing Irreversible Electroporation in people with Pancreatic Adenocarcinoma Resectable, run by University of Saskatchewan at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The operation to remove certain pancreatic cancers (Whipple procedure), even in 2017, remains one of the most complicated surgeries done in the abdomen. It carries a 50% chance of a complication, even in the world's largest pancreatic surgery centres. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Adenocarcinoma Resectable
What is being tested?
Irreversible Electroporation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
1 Oct 2021to Jan 2025
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

  • Biopsy-proven pancreatic adenocarcinoma of the head of the pancreas.
  • Age 18 to 75.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Pregnancy
  • Subjects who are medically unfit to receive a general anesthetic.
  • Patients with cardiac arrhythmia other than rate controlled atrial fibrillation.
  • Tumors greater than 3 cm.
  • Unresectable or locally advanced pancreatic cancer.
  • Patients with a high suspicion for lymph node metastasis or peripancreatic pathologic (> 1 cm) lymph nodes on imaging.
  • Metastatic pancreatic carcinoma, including unexpected peritoneal or liver metastases discovered at the time of laparotomy for planned IRE.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 0W8

Other trials in Canada

About this study

Official title: A Pilot Study of Irreversible Electroporation for the Treatment of Upfront Resectable Pancreatic Cancer in the Head of the Pancreas

The operation to remove certain pancreatic cancers (Whipple procedure), even in 2017, remains one of the most complicated surgeries done in the abdomen. It carries a 50% chance of a complication, even in the world's largest pancreatic surgery centres.

Saskatchewan is one of only two centres in Canada to have a promising new technology called Irreversible Electroporation (IRE) (NanoKnife®) available to our patients for the ablation (destruction) of cancers. IRE is different from other ablation treatments, including heat and even radiation, in that with IRE no heat is generated and there is minimal, if any, damage to nearby blood vessels, bowel, and ducts. Thus far, IRE has only been used as a "last resort" in cases where the pancreatic cancer cannot be removed with surgery, yet many patients whose tumor could likely be removed with a 'Whipple' have expressed a preference to undergo IRE instead of the Whipple procedure.

Read more

Our main research questions are: In comparison to Whipple procedure, is IRE an effective treatment of pancreatic cancer, and are complications reduced? Is IRE cost-effective? Based on the cases we have done and published series of IRE for stage III pancreatic cancer, we believe that IRE will be effective and safe in treating lesser stage (I and II) tumors in our proposed study.

This will be a pilot study of 12-15 patients, and all recruited patients will receive the IRE treatment and then be followed for up to 5 years for quality of life, recurrence, survival, and cost.

Read the detailed description
  • Subjects will receive a general anesthetic and will undergo a midline laparotomy and a careful inspection to ensure no distant metastases are obvious in the peritoneal cavity.
  • Ultrasound-guided IRE of the pancreatic mass will be performed by interventional radiologist Dr. Chris Wall as per the protocol of Martin et al [ ].
  • Subjects will be monitored for adverse events in the postoperative period until the time of discharge from the hospital, typically on the 5th or 6th day after the procedure.
  • Adjuvant chemotherapy is recommended following the procedure but it is not mandatory.
  • Patients will be assessed and offered single agent gemcitabine or combination of gemcitabine and capecitabine at the discretion of treating oncologists. It is recommended that patients begin treatment within 12 weeks after the procedure.
  • Specific drug reductions and management of will be made in accordance with the published recommendations for gemcitabine or gemcitabine plus capecitabine.
  • Patients will be scheduled for regular follow up and surveillance history and physical exam by the Hepatobiliary Surgeons Group.
  • The same surveillance protocol that is used after the Whipple procedure will be followed: bloodwork at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months (complete blood count, electrolytes, creatinine, liver enzymes, Ca 19.9) and imaging (Chest Xray and CT abdomen at 3 months, followed by a PET scan at 6 months, CT scan at 9 and 12 months, then yearly CT or MRI).
  • For study purposes, each scan will be re-reviewed by the same two radiologists with a goal of arriving at a consensus in each case.
  • Two validated QOL questionnaires, the FACT-Hep, which is specific to hepatic and pancreatic diseases, and the more general FACT-G questionnaire will be administered preoperatively and at 3 and 12 months.
  • Each IRE case will be matched 2:1 with patients undergoing the Whipple Procedure around the same time (within 12 months of each other) for non-locally advanced pancreatic cancer, matched by age +/- 5 years, gender, tumor size +/- 0.5 cm, and preoperative chemotherapy.
  • Survival curves will be analyzed using the Kaplan-Meier method, and differences between groups will be assessed using log-rank test.
  • Student's T test and the Mann-Whitney U test will be used for other comparisons between the two groups and p<0.05 will be taken to be significant. SPSS version 24 will be used for statistical analyses (SPSS Inc, Chicago, IL).
Being tested
Irreversible Electroporation
Keywords
Irreversible Electroporation, Pancreatic Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irreversible ElectroporationProcedure or surgery

    Also called NanoKnife, IRE

    Open Irreversible Electroporation by ultrasound guidance for tumors under 3 cm in diameter. Goal is to obtain an Amp rise of 12 or more

Study groups in NCT03337997
Study groupRoleWhat they receive
Study groupExperimentalAll patients in this pilot study are in the same group. All receive Irreversible Electroporation.
Receives: Procedure: Irreversible Electroporation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival

    Disease Free Survival

    Measured: 5 years

  2. Complications

    recorded and classified

    Measured: 3 months

Secondary outcomes (4)

  1. Length of Stay

    LOS

    Measured: 1 month

  2. Quality of Life (Functional Assessment of Cancer Therapy- for Hepatobiliary and Pancreatic Cancers) questionnaire

    This is a validated measure of quality of life in patients who have hepato-pancreatico-biliary cancers, and includes 45 items that the patient scores on a scale of 0-4, with 4 being very symptomatic and 0 being asymptomatic. Higher scores imply a worse quality of life.

    Measured: preoperatively, 3 months, 12 months

  3. Time to recurrence

    TTR

    Measured: 5 years

  4. Overall Survival

    OS

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2017
  2. Study start1 Oct 2021 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionJan 2025 (estimated)

Why it stopped: We have been unable to secure funding. Now we are in the middle of a pandemic.

Resources

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
Model description
Patients with biopsy-proven adenocarcinoma of the head of the pancreas deemed to be resectable by a multi-disciplinary team will be invited to participate.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03337997
Sponsor's protocol ID
IRE002
Status last verified
Apr 2021
First submitted
1 Nov 2017
Last updated
6 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Irreversible Electroporation in people with Pancreatic Adenocarcinoma Resectable, run by University of Saskatchewan at 1 site in Canada.

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 3 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: withdrawn, as of the sponsor's last update on 6 May 2021. 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 Canada. 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 withdrawn before enrolling participants, so there are no results.

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?

Disease Free Survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT03337997.

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 6 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in