ABSTRACT
When performing Breast Conserving Surgery (BCS) with Intraoperative Radiation Therapy (IORT), positive resection margin necessitates not only re-lumpectomy-but also the addition of fractionated whole breast radiation. This retrospective study of 106 patients undergoing BCS and IORT aims to evaluate intraoperative margin assessment use in our center, and the contribution of the MarginProbe device (MP) to achieving negative surgical margins. Eleven out of 106 lumpectomy specimens had a total of 17 margins positive for tumor cells. Intraoperative gross pathology identified 6 (43%) involved margins, MarginProbe detected 8 (50%), and their combined use allowed for detection of 12 (70.5%) involved margins. In conclusion, the adjunctive use of intraoperative gross pathology and MarginProbe reduced the number of lumpectomies with positive resection margins by more than 50%, decreasing the need for re-lumpectomy and the addition of whole breast radiation.
Subject(s)
Breast Neoplasms , Mastectomy, Segmental , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , Female , Humans , Intraoperative Care , Margins of Excision , Retrospective StudiesABSTRACT
BACKGROUND: Receiving real-time information on tissue properties while performing biopsy procedures has the potential of improving biopsy accuracy. The study goal was to test the ability of a miniature flexible Radio-Frequency (RF) sensor (Dune Medical Devices), designed to be mounted on the surface of surgical tools, in measuring and mapping the various breast tissue types and abnormalities in terms of electrical properties. METHODS: Between January and October 2012, 102 patients undergoing lumpectomy, open-biopsy or mastectomy, in 3 medical centers, were enrolled in this study. The device was applied to freshly excised specimens, with registration between device measurements and histology analysis. Based on histology, the dielectric properties of the various tissue types were derived. Additionally, the ability of the device to differentiate between malignant and non-malignant tissue was assessed. RESULTS: A total of 4322 measurements from 106 specimens from 102 patients were analyzed. The dielectric properties of 10 tissue types in the low RF-frequency range were measured, showing distinct differences between the various types. Based on the dielectric properties, a score variable was derived, which showed a correlation of 90 % between the RF measurements and the tissue types. Differentiation ability between tissue types was characterized using ROC curve analysis, with AUC of 0.96, and sensitivity and specificity of 90 and 91 % respectively, for tissue feature sizes at or above 0.8 mm. CONCLUSIONS: Using a radio-frequency near-field spectroscopy miniature flexible sensor the dielectric properties of multiple breast tissue types, both normal and abnormal, were evaluated. The results show promise in differentiating between various breast tissue types, and specifically for differentiation between cancer and normal tissues.
Subject(s)
Breast Neoplasms/diagnostic imaging , Breast/pathology , Signal Processing, Computer-Assisted/instrumentation , Spectroscopy, Near-Infrared/instrumentation , Adult , Aged , Area Under Curve , Biopsy , Breast/diagnostic imaging , Diagnosis, Differential , Female , Humans , Mastectomy , Mastectomy, Segmental , Middle Aged , ROC Curve , Sensitivity and SpecificityABSTRACT
BACKGROUND: This randomized, double-arm trial was designed to study the benefit of a novel device (MarginProbe, Dune Medical Devices, Caesarea, Israel) in intraoperative margin assessment for breast-conserving surgery (BCS) and the associated reduction in reoperations. METHODS: In the device group, the probe was applied to the lumpectomy specimen and additional tissue was excised according to device readings. Study arms were compared by reoperation rates and by correct surgical reaction confirmed by histology. RESULTS: Three hundred patients were enrolled. Device use was associated with improved correct surgical reaction, defined as additional re-excision in all histologically detected positive margins, with tumor within 1 mm of inked margin. The repeat lumpectomy rate was significantly reduced by 56% in the device arm: 5.6% versus 12.7% in the control arm. There were no differences in excised tissue volume or cosmetic outcome. CONCLUSIONS: Intraoperative use of the MarginProbe for positive margin detection is safe and effective in BCS and decreases the rate of repeat operations.
Subject(s)
Breast Neoplasms/pathology , Breast Neoplasms/surgery , Intraoperative Care/instrumentation , Mastectomy, Segmental/instrumentation , Equipment Design , Female , Humans , Middle Aged , Prospective Studies , Reoperation , Treatment OutcomeABSTRACT
INTRODUCTION: Optimal treatment for ureteral stones is still controversial. The main retreatment options include ureteroscopy and shock wave lithotripsy (ESWL). The study aimed to assess the efficacy of ESWL using the unmodified HM3 lithotripter (Dornier Medical Systems) to achieve stone-free status in patients with ureteral calculi, regardless of stone size and location along the ureter. MATERIAL AND METHODS: We retrospectively reviewed the charts and radiology studies of all patients who had ESWL for ureteral stones. Following ESWL with the HM3 lithotripter, patients had imaging examinations performed after 1 and 3 months, and thereafter, according to the residue status of the stones. RESULTS: During the years 1998-2003, 661 patients underwent ESWL for ureteral stones. The mean age was 51 years (range: 4-85 years) and the average stone size was 8 x 10 mm (range: 3-30 mm). Forty percent of the patients had upper ureteral calculi, 17% mid and 43% lower ureteral stone. Overall stone-free status was 93.6%. According to stone location, the success rate for upper ureteral calculi was 93.6%, and 93.6% and 95.5% for mid and lower ureteral stones. Complications were recorded in 28 (4.2%) patients, 20 had acute urinary tract infection treated with i.v. antibiotics, and 8 had renal colic treated conservatively. CONCLUSIONS: Our data shows that ESWL using HM3 lithotripter for ureteral stones at any level and size has a high success rate with minimal morbidity. ESWL using the HM3 lithotripter is our preferred treatment of choice for ureteral calculi.