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Logistic reasons
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| Name | Class |
|---|---|
| IGEA | INDUSTRY |
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Electrochemotherapy is a type of electroporation that allows the delivery of drugs to the cells through the local creation of pores in the cell membrane. The electric pulses can be applied directly to the neoplastic cells, allowing for the local concentration of a possible chemotherapeutic agent administered through the bloodstream. This technique does not use heat nor other thermal energies and it is performed using special needles/electrodes linked to a generator ("porator").
In this study this technique will be applied on unresectable pancreatic cancer, already submitted to neoadjuvant treatment and still unresectable, through laparotomy. Bleomycin will be the chemotherapeutic agent.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrochemotherapy with Bleomycin | Device | Application of Reversible Electroporation (Electrochemotherapy) with Bleomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of adverse events related with electrochemotherapy (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications are distinct in early (during hospitalization) and late (bile duct stenosis) that may appear during follow-up | through study completion, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Number of procedures planned actually performed | through study completion, 1 year |
| Tumour response | Analysis of effects of electrochemotherapy on tumor using RECIST criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Verona Hospital | Verona | 37134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25917204 | Result | Granata V, Fusco R, Piccirillo M, Palaia R, Petrillo A, Lastoria S, Izzo F. Electrochemotherapy in locally advanced pancreatic cancer: Preliminary results. Int J Surg. 2015 Jun;18:230-6. doi: 10.1016/j.ijsu.2015.04.055. Epub 2015 Apr 24. | |
| 27069445 | Result | Bimonte S, Leongito M, Granata V, Barbieri A, Del Vecchio V, Falco M, Nasto A, Albino V, Piccirillo M, Palaia R, Amore A, Giacomo Rd, Lastoria S, Setola SV, Fusco R, Petrillo A, Izzo F. Electrochemotherapy in pancreatic adenocarcinoma treatment: pre-clinical and clinical studies. Radiol Oncol. 2016 Feb 16;50(1):14-20. doi: 10.1515/raon-2016-0003. eCollection 2016 Mar 1. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D053672 | Electrochemotherapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000092722 | Electroporation Therapies |
| D018274 | Electroporation |
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| 12 months |
| Quality of life | Analysis of quality of life using the Karnovsky performance index | 12 months |
| Quality of life | Analysis of quality of life using the pain numeric scale | 12 months |
| Survival | Survival analysis through the calculation of overall survival | 12 months |
| Survival | Survival analysis through the calculation of progression free survival survival | 12 months |
| Immunomonitoring | Study of adaptive immunity through the sampling of Interleukin6 and Heat shock protein 70 levels at baseline and post-procedure | From baseline to the first month |
| 18987914 | Result | Campana LG, Mocellin S, Basso M, Puccetti O, De Salvo GL, Chiarion-Sileni V, Vecchiato A, Corti L, Rossi CR, Nitti D. Bleomycin-based electrochemotherapy: clinical outcome from a single institution's experience with 52 patients. Ann Surg Oncol. 2009 Jan;16(1):191-9. doi: 10.1245/s10434-008-0204-8. Epub 2008 Nov 6. |
| 26029026 | Result | Girelli R, Prejano S, Cataldo I, Corbo V, Martini L, Scarpa A, Claudio B. Feasibility and safety of electrochemotherapy (ECT) in the pancreas: a pre-clinical investigation. Radiol Oncol. 2015 Mar 25;49(2):147-54. doi: 10.1515/raon-2015-0013. eCollection 2015 Jun. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003584 |
| Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |