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The aim of the current study is to evaluate the detection rate of micro- and macro-metastases of the One-Step Nucleic Acid Amplification (OSNA) compared to frozen section examination and subsequent ultra-staging examination in early stage endometrial cancer (EC). From March 2016 to June 2016, data of 40 consecutive FIGO stage I EC patients were prospectively collected in an electronic database. The sentinel lymph node mapping was performed in all patients. All mapped nodes were removed and processed. Sentinel lymph nodes were sectioned and alternate sections were respectively examined by OSNA and by frozen section analysis. After frozen section, the residual tissue from each block was processed with step-level sections (each step at 200 micron) including H&E and IHC slides. Sentinel lymph nodes mapping was successful in 29 patients (72.5%). In the remaining 11 patients (27.5%), a systematic pelvic lymphadenectomy was performed. OSNA assay sensitivity and specificity were 87.5% and 100% respectively. Positive and negative predictive values were 100% and 99% respectively, with a diagnostic accuracy of 99%. As far as frozen section examination and subsequent ultra-staging analysis was concerned, we reported sensitivity and specificity of 50% and 94.4% respectively; positive and negative predictive values were 14.3% and 99%, respectively, with an accuracy of 93.6%. In one patient, despite negative OSNA and frozen section analysis of the sentinel node, a macro-metastasis in 1 non-sentinel node was found. The combination of OSNA procedure with the sentinel lymph node mapping could represent an efficient intra-operative tool for the selection of early-stage EC patients to be submitted to systematic lymphadenectomy.

Background To evaluate the safety and feasibility of the new robotic TELELAP ALF-X platform in a heterogeneous series of gynecological procedures. Methods Between September 2013 and May 2014, 146 patients were enrolled in this Phase II study trial. Patients with presumed benign or borderline adnexal disease, and benign and early stage malignant uterine disease were prospectively included. Results Median age was 52 years (range 19–79 years), and median BMI was 23.7 (range 17.3–34.0 kg/m 2 ). Sixty-two patients (32.5 %) underwent mono/bilateral salpingo-oophorectomy or cyst removal (Group A), four patients (2.7 %) myomectomy (Group B), 46 patients (31.5 %) total hysterectomy (Group C), and 34 (23.3 %) endometrial cancer staging (Group D). Median docking time was 7 min (range 3–36). Median OT was 35 min (range 17–145) in the Group A, 40 min (range 10–50) in the Group B, 133 min (range 58–320) in the Group C, and 160 min (range 69–290) in the Group D. Reduction in OT over the study period for hysterectomy ( p  < 0.001) and adnexal surgery ( p  < 0.002) was observed. We registered two laparoscopic conversion (3.2 %) in the Group A and two (4.3 %) in the Group C. In the Group D, we showed one (2.9 %) laparoscopic and two (5.8 %) laparotomic conversions. One patient (2.17 %) in the Group C was readmitted in the early postoperative period for severe vaginal bleeding. Conclusions We report the first series of a novel robotic approach for the treatment of various gynecological conditions. When performed by experienced minimally invasive surgeons, TELELAP ALF-X is feasible and safe. Further studies are mandatory to define the benefits, advantages, and costs of this new robotic approach with respect to others minimally invasive approaches.

Background This study was designed to evaluate the positron emission tomography–laparoscopy-based method in the prediction of complete/optimal cytoreduction in platinum sensitive recurrent epithelial ovarian cancer patients. Methods We analysed 223 consecutive recurrent epithelial ovarian cancer patients. Inclusion criteria were absence of extra-abdominal disease and Eastern Cooperative Oncology Group Performance Status ≤2. Complete and optimal secondary cytoreduction are defined as macroscopic absence or less than 1 cm of residual tumor at the end of surgery. Results Laparoscopy was feasible in 210 of 223 patients (94.2 %). Laparoscopy stated 127 (60.5 %) possible cytoreductions and 83 (39.5 %) systemic chemotherapies. In the same population, AGO score evaluation avowed 150 possible cytoreduction (71.5 %) and 60 unresectable women (28.5 %). Overall, 115 of 210 patients (54.7 %) underwent successful secondary cytoreduction: complete and optimal cytoreduction was obtained in 103 (89.5 %) and 12 (10.5 %) patients, respectively. Laparoscopy obtained a positive predictive value of 91.3 %. Laparoscopy recovered to secondary cytoreduction 13 of 60 patients (21.7 %) deemed as not resectable according to AGO score. Forty-eight of 150 AGO score positive patients (32 %) were judged nonresectable by laparoscopy. Conclusions This study confirmed that laparoscopy could be effective for the selection of platinum-sensitive recurrent epithelial ovarian cancer patients suitable for complete cytoreduction.

ObjectivesLaparoscopy is commonly used for endometrial cancer treatment, and sentinel lymph node (SLN) mapping has become the standard procedure for nodal assessment. Despite the standardization of the technique, there is no definitive data regarding its failure rate. The objective of this study is to identify factors associated with unsuccessful SLN mapping in endometrial cancer patients undergoing laparoscopic SLN mapping after intracervical indocyanine green (ICG) injection.MethodsWe retrospectively evaluated a consecutive series of endometrial cancer patients who underwent laparoscopic SLN mapping with intracervical ICG injection, in four oncological referral centers from January 2016 to July 2019. Inclusion criteria were biopsy-proven endometrial cancer, total laparoscopic approach, and intracervical ICG injection. Exclusion criteria were evidence of lymph node involvement or extrauterine disease at pre-operative imaging, synchronous invasive cancer, the use of tracers different from ICG, and the use of neoadjuvant treatment. Bilateral and failed bilateral SLN mapping groups were compared for clinical and pathological features. In patients with an unsuccessful procedure, side-specific lymphadenectomy was performed. Logistic regression was used to identify predictors of failure.ResultsA total of 376 patients were included in the study. The overall bilateral and unilateral SLN detection rates were 96.3%, 76.3%, and 20.0% respectively. The failed bilateral mapping detection rate was 23.7%. The median number of sentinel nodes removed was 2.2 (range, 0–5). After multivariate analysis, lymph vascular space involvement [OR 2.4 (1.04–1.12), P=0.003], non-endometrioid histology [OR 3.0 (1.43–6.29), P=0.004], and intraoperative finding of enlarged lymph node [OR 2.3 (1.01–5.31), P=0.045] were identified as independent predictors of failure of SLN mapping.ConclusionLymph vascular space involvement, non-endometrioid histology, and intra-operative finding of enlarged lymph nodes were identified as independent risk factors for unsuccessful mapping in patients undergoing laparoscopic SLN mapping.

Introduction/BackgroundThe objective of this study is to establish the clinical performance of the One Step Nucleic Acid Amplification (OSNA) method for the detection of sentinel lymph node (SNL) metastases in women with early-stage endometrial cancer (EC) compared to standard Ultrastaging (US).MethodologyThis is a prospective, multicentric, observational study, women with early-stage EC underwent surgical staging with SNL identification. SNLs were serially sectioned at 2 mm slices thickness perpendicular to the longest axis of the node, the odd slices were submitted to ultra-staging, according to our institutional ultrastaging protocol, even slices were submitted to the OSNA analysis.ResultsThis is the largest study, until now, with three-hundred-and-sixteen patients enrolled with 668 SNLs analyzed with the two methods OSNA and US. OSNA assay detected 22 (3,3%) positive SNLs of which 17 (2,5%) micrometastases, and 5 (0,7%) macrometastases, whereas pathological ultrastaging detected 24 (3,6%) positive SNLs of which 15 (2,2%) micrometastases and 9 (1,3%) of macrometastases. In addition, OSNA detected 649 negative nodes (including 8 ITC), while Ultrastaging 644 negative nodes (with 26 ITC.) Using Ultrastaging as a reference method the specificity of 98,4%, the diagnostic accuracy of 96,7%, and the negative predictive value of 98,1% were attended. Discordant results were found in 22 SNLs (3,2%) corresponding to 20 patients (6,3%). We found 10 false-positive SNLs, all micrometastases, and 12 false-negative lymph nodes of which 9 micrometastases and 3 macrometastases.ConclusionAlthough only portions of a whole lymph node have been examined with OSNA analysis, it has proved to be highly specific with high diagnostic accuracy, a high negative predictive value, and moderate concordance with the standard US. Therefore, we believe that OSNA is a valid method for analyzing lymph node metastases in patients with apparent early-stage EC, which allows us to analyze the entire lymph node with a standardized method.

ObjectiveTo evaluate the diagnostic performance of the one-step nucleic acid amplification (OSNA) method for the detection of sentinel lymph node (SLN) metastases in women with apparent early-stage endometrial cancer compared with standard ultrastaging.MethodsProspective, multicentric, interventional study. Patients with apparent early-stage endometrial cancer who underwent primary surgical staging with SLN mapping were included. SLNs were serially sectioned with 2 mm slices perpendicular to the longest axis of the node: the odd slices were submitted to ultrastaging, whereas the even slices were submitted to the OSNA analysis. Diagnostic performance was calculated taking ultrastaging as referral standard.ResultsThree-hundred and sixteen patients with 668 SLNs were included. OSNA assay detected 22 (3.3%) positive SLNs, of which 17 (2.5%) were micrometastases and 5 (0.7%) macrometastases, whereas ultrastaging detected 24 (3.6%) positive SLNs, of which 15 (2.2%) were micrometastases and 9 (1.3%) macrometastases (p=0.48). Regarding negative SLNs, OSNA detected 646 (96.7%) negative nodes, including 8 (1.2%) isolated tumor cells, while ultrastaging detected 644 (96.4%) negative nodes with 26 (3.9%) isolated tumor cells. Specificity of OSNA was 98.4% (95% CI 97.5 to 99.4), accuracy was 96.7% (95% CI 95.4 to 98.1), sensitivity was 50% (95% CI 30.0 to 70.0), while negative predictive value was 98.1% (95% CI 97.1 to 99.2). Discordant results were found in 22 SLNs (3.3%) corresponding to 20 patients (6.3%). These were 10 (1.5%) false-positive SLNs (all micrometastases): one (0.1%) of these was a benign epithelial inclusion at ultrastaging. There were 12 (1.8%) false-negative SLNs of OSNA, of which 9 (1.3%) were micrometastases and 3 (0.5%) macrometastases. Overall, 17/668 (2.5%) benign epithelial inclusions were detected at ultrastaging.ConclusionThe OSNA method had high specificity and high accuracy in detecting SLN metastasis in apparent early-stage endometrial cancer. The advantage of the OSNA method could be represented as the possibility to analyze the entire lymph node thus eliminating sampling bias.

Robot-assisted surgery has been proven to offer improvements in term of surgical learning curve and feasibility of minimally invasive surgery, but has often been criticized for its longer operative times compared to conventional laparoscopy. Additional times can be split into time required for system set-up, robotic arms docking and calibration of robotic instruments; secondly, surgeon’s learning curve. One of the newest systems recently launched on the market is the Hugo™ RAS (MEDTRONIC Inc, United States). As some of the earliest adopters of the Hugo™ RAS system technology, we present our data on robotic docking learning curve for the first 192 gynecologic robotic cases performed at our institution. Our data indicates that robotic set-up and docking with the new Hugo™ RAS robotic surgical system can be performed time-effectively and that the specific robotic docking learning curve is comparable to preexisting data for other platforms. This preliminary insights into this recently released system may be worthwhile for other centers which may soon adopt this new technology and may need some relevant information on topics such as OR times. Further studies are necessary to assess the different features of the Hugo™ RAS considering other technical and surgical aspects, to fully become familiar with this novel technology.

OBJECTIVEThe identification of patients with endometrial cancer (EC) at higher risk for relapse is critical to individualize and better tailor postoperative treatment. No evidence is available regarding the possible association between tumor size (TS) and the risk of local recurrence. The purpose of this study was to analyze the correlation between TS and risk/type of recurrence in EC patients, stratified according to the new European Society of Medical Oncology-European Society of Gynecological Oncology-European Society for Radiotherapy and Oncology classification. METHODSData of patients with histologically proven EC who received primary surgical treatment between November 1999 and June 2015 were retrospectively retrieved from 5 institutions. Optimal TS cutoff was calculated using a receiver operating characteristic curve. Site of recurrence as a function of TS and groups of risk were analyzed. Local recurrence-free survival, recurrence-free survival, and overall survival were calculated using the Kaplan-Meier method. RESULTSData of 1166 patients were analyzed. Among them, 514 (44.1%) had low-risk EC, 174 (14.9%) had intermediate risk EC, 173 (14.8%) had high–intermediate risk EC, and 305 (26.2%) had high-risk EC. A total of 134 (11.5%) women had recurrence47 (4%) of them had local relapse, 30 (2.6%) had locoregional relapse, and 57 (4.9%) had distant relapse. Tumor size 25 mm or greater emerged as the threshold for the prediction of a higher rate of local recurrence (P < 0.0001, hazard ratio = 18.2, P = 0.005) and a lower local recurrence-free survival and recurrence-free survival (P < 0.0001) only in patients with low-risk EC. There was no statistically significant correlation between TS and recurrence in the other risk groups. CONCLUSIONSIn this very large series, tumor size emerges as an independent prognostic factor of local recurrence in women with low-risk EC and could be a valuable additional criterion to personalize the treatment approach to these patients.

Objectives: Sentinel lymph node biopsy is considered a crucial step in endometrial cancer staging. Cervical injection has become the most favored technique and indocyanine green has been demonstrated to be more accurate than other tracers. Different near-infrared camera systems are currently being used to detect indocyanine green in sentinel lymph nodes and have been compared in different patients. The present study aimed to determine the number and site of sentinel lymph nodes detected in the same patients with two different near-infrared technologies. Methods: This is a prospective, single-center, observational, non-sponsored study. Patients with presumed uterine-confined endometrial cancer were prospectively enrolled. After cervical injection, two different near-infrared cameras were used to detect sentinel lymph nodes at the same time: Olympus, Tokyo, Japan—considered the standard (SNIR); and Medtronic, Minneapolis, MN, USA with VISION SENSE® which is a new laser near-infrared (LNIR) fluorescence laparoscope. The two cameras were alternatively switched on to detect sentinel lymph nodes in the same patients. Results: Seventy-four consecutive patients were included in the study. Most of the patients were diagnosed with endometrioid histology (62, 83.8%), FIGO stage IA (48, 64.9%), grade 2 (43, 58.1%), and underwent surgery with laparoscopic approach (70, 94.0%). The bilateral detection rate was 56/74 (75.7%) with SNIR and 63/74 (85.1%) with LNIR (p = 0.214). The total number of sentinel lymph nodes identified in the left hemipelvis was 65 and 70 with SNIR and LNIR, respectively; while in the right hemipelvis, there were 74 and 76, respectively. The median number of sentinel lymph nodes identified with SNIR and LNIR was 2 (range, 0–4) and 2 (range, 0–4), respectively (p = 0.370). No difference in site of sentinel lymph node detection was evident between the two technologies (p = 0.994). Twelve patients (16.2%) had sentinel lymph node metastasis: in all cases metastatic sentinel lymph nodes were detected both with Olympus and LNIR. Conclusions: No difference in bilateral detection rate and number or site of sentinel lymph node detection was evident comparing two different technologies of near-infrared camera for ICG detection in endometrial cancer patients. No difference in sentinel lymph node metastases identification was detected between the two technologies.