Pancreatic Cancer Research

Clinical trialPhase 1 / Phase 2Completed

PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma

PANFIRE - Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma - a Phase I Clinical Trial

Outcome
Finished, no results posted
Phase
Phase 1 / Phase 2
Status
Completed
Study type
Interventional
Start
September 2013
Expected end
October 2016
Enrollment
50 participants
Sites
1
Primary outcomes
Safety (number of adverse events)
Sponsor
Other
Results posted
No
Last update
20 December 2022

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Brief summary public domain (ClinicalTrials.gov)

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.