PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma (PANFIRE)
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.
The purpose of this study is to investigate the safety of percutaneous IRE in the treatment of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are feasibility and efficacy of IRE based upon symptomatic response and tumor response.
Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. After IRE, patients will be carefully monitored and any (serious) adverse events are registered. Follow-up will consist of frequent CT scanning, as well as serum CA19.9 tumor marker.
We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor control, without causing severe complications.
|Locally Advanced Pancreatic Carcinoma (LAPC) Non-metastasized Unresectable Pancreatic Carcinoma Pancreatic Cancer||Device: NanoKnife "Irreversible electroporation (IRE)"||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PANFIRE - Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma - a Phase I Clinical Trial|
- Safety (number of adverse events) [ Time Frame: early: 90 days; late: 12 months ]Number of adverse events of IRE-treatment (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications related to IRE are early complications during hospital admission (e.g. bile leak, bowel leak, infection, pancreatitis), or late complications of IRE such as bile duct stenosis that become apparent during follow-up in the year after treatment.
- Tumor response [ Time Frame: 12 months ]
- Ablation success: the ability to deliver the planned therapy and at 3 months to have no evidence of residual tumor;
- Local recurrence rate (LRR): defined as the reappearance of viable tumor after a period of time during which viable tumor could not be detected;
- Overall survival and (local and distant) progression-free survival.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Irreversible electroporation
Single arm study: Percutaneous irreversible electroporation of locally advanced pancreatic carcinoma
Device: NanoKnife "Irreversible electroporation (IRE)"
Tumor ablation with irreversible electroporation with the NanoKnife
Please refer to this study by its ClinicalTrials.gov identifier: NCT01939665
|Contact: Laurien GPH Vroomen, MDfirstname.lastname@example.org|
|Contact: Martijn R Meijerink, MD, PhDemail@example.com|
|VU University Medical Center||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1081 HV|
|Contact: Laurien GPH Vroomen, MD +31204440347 firstname.lastname@example.org|
|Contact: Martijn R Meijerink, MD, PhD +31204444444 email@example.com|
|Principal Investigator: Geert Kazemier, Prof. Dr.|
|Principal Investigator: Martijn R Meijerink, MD, PhD|
|Principal Investigator:||Martijn R Meijerink, MD, PhD||VU University Medical Center, Department of Radiology and Nuclear Medicine|
|Principal Investigator:||Geert Kazemier, Prof. Dr.||VU University Medical Center, Department of Surgery|
|Study Director:||Cornelis van Kuijk, Prof. Dr.||VU University Medical Center, Head of Department of Radiology,|