A Pilot Study of IRE for Resectable Pancreatic Cancer

NCT03337997 | Withdrawn

• 1 other identifier: IRE002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Irreversible Electroporation; Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Disease Free Survival

  Disease Free Survival

  5 years

• Complications

  recorded and classified

  3 months

Secondary Outcomes (4)

• Length of Stay

  1 month

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

  preoperatively, 3 months, 12 months

• Time to recurrence

  5 years

• Overall Survival

  5 years

Study Arms (1)

Study group

EXPERIMENTAL

All patients in this pilot study are in the same group. All receive Irreversible Electroporation.

Procedure: Irreversible Electroporation

Interventions

Irreversible Electroporation PROCEDURE

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

Also known as: NanoKnife, IRE

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Interventions

Electroporation

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: CT scans and PET scans will be read by two radiologists and concensus obtained. The two radiologists will be unaware of prior chemo, patient age, original tumor size.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 9, 2017
• Study Start: October 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2025
• Last Updated: May 6, 2021

Record last verified: 2021-04

Locations

CA (1)