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- Sperimentazione clinica NCT00972010
Study to Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade
A Prospective, Controlled Study To Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade Compared to Traditional Electrosurgery
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Breast conservation therapy (BCT) is the standard surgical treatment for breast cancer. The goal of BCT is total excision of the malignant lesion while simultaneously preserving the cosmetic appearance and functionality of the breast. Despite advances in technique and pathologic analysis; however, 20-50% of malignant breast lump excisions have cancer present to the edge of the excision margin (defined as a "positive" margin). Excisions that are found to be margin positive require a secondary excision; however, in these cases residual disease is found to be present in only 40-70% of cases. Some researchers have hypothesized that re-excision was unnecessary in a certain percentage of cases. Currently there are no routinely utilized method for intra-operative interpretation of surgical margins. Touch preps or imprint cytology has been used in the past in some centers but it is not used routinely because an experienced cytopathologist is needed to correctly interpret the slides.
The standard of care to evaluate surgical margins is based on permanent section. Margins are considered negative if there is greater than 1 mm of normal tissue between cancer cells to the excised surface. Many factors for this discrepancy have been postulated, including artifact associated with the inking process and with electrosurgery induced damage of the margin during excision (thermal injury); therefore, creating a "false positive" impression of tumor cells present at surgical margins. We propose a clinical study to evaluate the effects of thermal injury in breast cancer excision using traditional electrosurgery (i.e., the "Bovie") compared to the pulsed RF technology with the PEAK PlasmaBlade. We hypothesize that the PlasmaBlade will impart less thermal injury to the incised breast tissue (malignant and normal) and will increase the specificity of the margin status. The majority of breast cancers are removed by traditional electrocautery. We are just starting to utilize this new technology for soft tissue dissection at UCSD.
The PEAK PlasmaBlade is a family of disposable surgical cutting and coagulation devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral damage. The PlasmaBlade is based on proprietary pulsed plasma technology. This technology represents an evolutionary leap in the advancement of radiofrequency surgical technologies, which originated with traditional electrosurgery and progressed to plasma-mediated energy devices. The PlasmaBlade tissue dissection devices are FDA-cleared and commercially available.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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California
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La Jolla, California, Stati Uniti, 92037
- Thornton Hospital
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La Jolla, California, Stati Uniti, 92093
- Rebecca and John Moores Cancer Center
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San Diego, California, Stati Uniti, 92103
- UCSD Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria
- Women or men with an established diagnosis of an invasive ductal carcinoma
- Women or men with tumors > 1cm
- Women undergoing Breast Conservation Operations
- Women or men may have had prior chemotherapy as long as their treatment was completed >2 weeks prior to enrollment with recovery from any toxicities
Exclusion Criteria
- No established diagnosis of breast cancer
- Women or men with tumors <1 cm
- Women or men undergoing total mastectomy
- Women or men who have had prior radiation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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To compare the thermal injury artifact produced by traditional electrosurgery vs. the PEAK PlasmaBlade by intensive pathologic analysis both by gross inspection, touch imprint, and permanent histologic analysis.
Lasso di tempo: 1 year
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1 year
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Sarah L Blair, MD, University of California, San Diego
Pubblicazioni e link utili
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 090314
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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