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.
Papers 2
- Builds on itPercutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicente… DOI 10.1148/radiol.2019191109↗
- Builds on itAssessment of Nutritional Status, Digestion and Absorption, and Quality of Life in Patients with Locally Advanced Pancr… DOI 10.1155/2017/6193765↗