Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study)
Last updated on July 2021Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 40
Summary
- Conditions
- Pancreas Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study will be conducted on patients with resectable pancreatic cancer. 20 patients will be included in phase I clinical study and additional 20 patients in phase II clinical study (or in the extension of the clinical study). After surgical resection of pancreatic cancer, the posterior resection ...
The study will be conducted on patients with resectable pancreatic cancer. 20 patients will be included in phase I clinical study and additional 20 patients in phase II clinical study (or in the extension of the clinical study). After surgical resection of pancreatic cancer, the posterior resection surface will be treated with purpose to lower disease recurrence rate. Plate electrodes will be used for ECT treatment, the electrodes will be placed between choledochal cut-end, truncus celiacus, remaining of the pancreas and aortal lymph nodes. ECT will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2). Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart. All patients will be treated after the procedure has been thoroughly described to them and have signed informed consent.
Tracking Information
- NCT #
- NCT04281290
- Collaborators
- Institute of Oncology Ljubljana
- Investigators
- Principal Investigator: Mihajlo Djokic, MD, PhD University Medical Centre Ljubljana, Ljubljana, Slovenia Study Director: Blaz Trotovsek, MD, PhD University Medical Centre Ljubljana, Ljubljana, Slovenia Study Director: Gregor Sersa, PhD Institute of Oncology, Ljubljana, Slovenia Study Chair: Zan Cebron, MD University Medical Centre Ljubljana, Ljubljana, Slovenia Study Chair: Miha Petric, MD University Medical Centre Ljubljana, Ljubljana, Slovenia Study Chair: David Badovinac, MD University Medical Centre Ljubljana, Ljubljana, Slovenia Study Chair: Masa Bosnjak, PhD Institute of Oncology, Ljubljana, Slovenia Study Chair: Bostjan Markelc, PhD Institute of Oncology, Ljubljana, Slovenia Study Chair: Maja Cemazar, PhD Institute of Oncology, Ljubljana, Slovenia
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