Trials / Completed
CompletedNCT01939665
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Amsterdam UMC, location VUmc · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Locally Advanced Pancreatic Carcinoma (LAPC)
- Non-metastasized Unresectable Pancreatic Carcinoma
- Pancreatic Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NanoKnife "Irreversible electroporation (IRE)" | Tumor ablation with irreversible electroporation with the NanoKnife |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2013-09-11
- Last updated
- 2022-12-20
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01939665. Inclusion in this directory is not an endorsement.