Clinical trialNACompleted
A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer
Irreversible Electroporation for Locally Advanced Pancreatic Ductal Adenocarcinoma (LEAP TRIAL): A Phase I/II Prospective Trial
- Outcome
- Finished, no results posted
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 22 September 2017
- Expected end
- 14 July 2022
- Enrollment
- 12 participants
- Sites
- 1
- Primary outcomes
- Adverse event rate; Overall survival rate
- Sponsor
- Other
- Results posted
- No
- Last update
- 11 August 2022
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Brief summary public domain (ClinicalTrials.gov)
This I/II study will evaluate to see how safe and useful irreversible electroporation (also called NanoKnife) is in patients with locally advanced pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
In this phase I/II trial, patients with locally advanced pancreatic ductal carcinoma will be assigned to receive interventional treatment of irreversible electroporation (IRE). IRE will be performed by laparotomy under general anesthesia in the operating room. All patients enrolled in the study will have a biopsy at the time of laparotomy. Blood will be collected for regular blood tests and correlative studies at baseline and during the study. Computed tomography (CT) scans will be done at baseline, 4 weeks post treatment, 12 weeks, 24 weeks, and 36 weeks follow up. Quality of Life (QOL) questionnaires will be completed at baseline and during the study. Patients will be given optional consent for storage of any leftover tissue and blood samples for future analysis. Patients will be followed up 4 weeks post treatment, then every 12 weeks until death.