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A Pilot Study of IRE for Resectable Pancreatic Cancer

NCT03337997 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-05-06

No results posted yet for this study

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.

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.

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.

Conditions

  • Pancreatic Adenocarcinoma Resectable

Interventions

PROCEDURE

Irreversible Electroporation

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

Sponsors & Collaborators

  • Saskatchewan Health Research Foundation

    collaborator OTHER

  • University of Saskatchewan

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2021-12-31
Completion
2025-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03337997 on ClinicalTrials.gov