Minimally invasive versus open pelvic exenteration in gynecological malignancies: a propensity-matched survival analysis.

OBJECTIVE: The primary endpoint of this study was to compare the disease-free survival of patients undergoing open versus minimally invasive pelvic exenteration. The secondary endpoints were cancer-specific survival and peri-operative morbidity. METHODS: A multi-center, retrospective, observational cohort study was undertaken. Patients undergoing curative and palliative anterior or total pelvic exenteration for gynecological cancer by a minimally invasive approach and an open approach between June 2010 and May 2021 were included. Patients with distant metastases were excluded. A 1:2 propensity match analysis between patients undergoing minimally invasive and open pelvic exenteration was performed to equalized baseline characteristics. RESULTS: After propensity match analysis a total of 117 patients were included, 78 (66.7%) and 39 (33.3%) in the open and minimally invasive group, respectively. No significant difference in intra-operative (23.4% vs 10.3%, p=0.13) and major post-operative complications (24.4% vs 17.9%, p=0.49) was evident between the open and minimally invasive approach. Patients undergoing open pelvic exenteration received higher rates of intra-operative transfusions (41.0% vs 17.9%, p=0.013). Median disease-free survival was 17.0 months for both the open and minimally invasive groups (p=0.63). Median cancer-specific survival was 30.0 months and 26.0 months in the open and minimally invasive groups, respectively (p=0.80). Positivity of surgical margins at final histology was the only significant factor influencing the risk of recurrence (hazard ratio (HR) 2.38, 95% CI 1.31 to 4.31) (p=0.004), while tumor diameter ≥50 mm at the time of pelvic exenteration was the only significant factor influencing the risk of death (HR 1.83, 95% CI 1.08 to 3.11) (p=0.025). CONCLUSION: In this retrospective study no survival difference was evident when minimally invasive pelvic exenteration was compared with open pelvic exenteration in patients with gynecological cancer. There was no difference in peri-operative complications, but a higher intra-operative transfusion rate was seen in the open group.

Long-term survival outcomes in high-risk endometrial cancer patients undergoing sentinel lymph node biopsy alone versus lymphadenectomy.

OBJECTIVE: Endometrial cancer is the most common gynecologic neoplasm. To date, international guidelines recommend sentinel lymph node biopsy for low-risk neoplasms, while systematic lymphadenectomy is still considered for high-risk cases. This study aimed to compare the long-term survival of high-risk patients who were submitted to sentinel lymph node biopsy alone versus systematic pelvic lymphadenectomy. METHODS: Patients with high-risk endometrial cancer according to the 2021 European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology risk classification were retrospectively analyzed. The primary aim of the study was to compare the long-term overall survival and disease-free survival of high-risk endometrial cancer patients undergoing sentinel lymph node biopsy versus systematic lymphadenectomy. A supplementary post-hoc survival analysis of cases with nodal metastasis was performed to compare sentinel lymph node and lymphadenectomy survival outcomes in this subset of patients. RESULTS: The study enrolled 237 patients with histologically proven high-risk endometrial cancer. Patients were followed up for a median of 31 months (IQR 18-40). During the follow-up, 38 (16.0%) patients had a recurrence, and 19 (8.0%) patients died. Disease-free survival (85.2% vs 82.8%; p=0.74) and overall survival (91.3% vs 92.6%; p=0.62) were not different between the sentinel lymph node alone and lymphadenectomy groups. Furthermore, neither overall survival (96.1% vs 91.4%; p=0.43) nor disease-free survival (83.7% vs 76.4%; p=0.46) were different among sentinel lymph node alone and lymphadenectomy groups in patients with nodal metastasis. CONCLUSIONS: Sentinel lymph node mapping alone in high-risk endometrial cancer appears to be an oncologically safe technique over a long observational time. Systematic lymphadenectomy in this population does not offer a survival advantage.

Detection of sentinel lymph node in vulvar cancer using 99mTc-labeled colloid lymphoscintigraphy, blue dye, and indocyanine-green fluorescence: a meta-analysis of studies published in 2010-2020.

OBJECTIVES: Sentinel lymph node (SLN) biopsy is widely accepted in the surgical staging of early vulvar cancer, although the most accurate method for its identification is not yet defined. This meta-analysis aimed to determine the technique with the highest pooled detection rate (DR) for the identification of SLN and compare the average number of SLNs detected by planar lymphoscintigraphy (PL), single-photon emission computed tomography/computed tomography (SPECT/CT), blue dye and indocyanine green (ICG) fluorescence. METHODS: The meta-analysis was conducted according to the PRISMA guideline. The search string was: "sentinel" and "vulv*", with date restriction from 1st January 2010 until Dec 31st, 2020. Three investigators selected studies based on: (1) a study cohort or a subset of a minimum of 10 patients with vulvar cancer undergoing either PL, SPECT/CT, blue-dye, or ICG fluorescence for the identification of SLN; (2) the possibility to extrapolate the DR or the average number of SLNs detected by a single technique (3) no evidence of other malignancies in the patient history. RESULTS: A total of 30 studies were selected. In a per-patient and a per-groin analysis, the DR for SLN of PL was respectively 96.13% and 92.57%; for the blue dye was 90.44% and 66.21%; for the ICG, the DR was 91.90% and 94.80%. The pooled DR of SPECT/CT was not calculated, since only two studies were performed in this setting. At a patient-based analysis, no significant difference was documented among PL, blue dye, and ICG (p = 0.28). At a per-groin analysis, PL and ICG demonstrated a significantly higher DR compared to blue dye (p < 0.05). The average number of SLNs, on a per-patient analysis, was available only for PL and ICG with a median number of 2.61 and 1.78 lymph nodes detected, respectively, and no significant statistical difference. CONCLUSIONS: This meta-analysis favors the use of ICG and PL alone and in combination over blue dye for the identification of the SLN in vulvar cancer. Future studies may investigate whether the combined approach allows the highest DR of SLN in patients with vulvar cancer.

The role of surgery in platinum-resistant ovarian cancer: A call to the scientific community.

In the last decade, a growing attention has been focused on identifying effective therapeutic strategies also in the orphan clinical setting of women with platinum-resistant disease. In this context, secondary cytoreductive surgery (SCS) remains a potential approach only in women with platinum sensitive relapse, but experimental data have been published supporting the role of SCS also in patients with platinum-resistant recurrence. In particular, surgery is emerging as a potential option in specific subgroups of women, such as those patients with low-grade serous histology, or low-volume relapse with disease located in the so-called pharmacological sanctuaries. Furthermore, contrasting evidences have suggested a potential role in this clinical setting of SCS combined with intraperitoneal hyperthermic chemotherapy. In this complex scenario we review here the available evidences regarding the role surgery in ovarian cancer patients with platinum resistant disease, trying also to understand which patients may benefit from this challenging, experimental approach.

Predictive Score of Nodal Involvement in Endometrial Cancer Patients: A Large Multicentre Series.

BACKGROUND: Sentinel lymph node (SLN) biopsy is considered the standard of care in early-stage endometrial cancer (EC). For SLN failure, a side-specific lymphadenectomy is recommended. Nevertheless, most hemipelvises show no nodal involvement. The authors previously published a predictive score of lymphovascular involvement in EC. In case of a negative score (value 3-4), the risk of nodal metastases was extremely low. This multicenter study aimed to analyze a predictive score of nodal involvement in EC patients. METHODS: The study enrolled patients with EC who had received comprehensive surgical staging with nodal assessment. A preoperative predictive score of nodal involvement was calculated for all the patients before surgery. The score included myometrial infiltration, tumor grading (G), tumor diameter, and Ca125 assessment. The STARD (standards for Reporting Diagnostic accuracy studies) guidelines were followed for score accuracy. RESULTS: The study analyzed 1038 patients and detected 155 (14.9%) nodal metastases. The score was negative (3 or 4) for 475 patients and positive (5-7) for 563 of these patients. The score had a sensitivity of 83.2%, a specificity of 50.8%, a negative predictive value of 94.5%, and a diagnostic value of 55.7%. The area under the curve was 0.75. The logistic regression showed a significant correlation between a negative score and absence of nodal metastasis (odds ration [OR], 5.133, 95% confidence interval [CI], 3.30-7.98; p < 0.001). CONCLUSION: The proposed predictive score is a useful test to identify patients at low risk of nodal involvement. In case of SLN failure, the application of the current score in the SLN algorithm could allow avoidance of unnecessary lymphadenectomies.

Impact of Obesity on Sentinel Lymph Node Mapping in Patients with apparent Early-Stage Endometrial Cancer: The ObeLyX study.

OBJECTIVE: Conflicting data exists on the impact of Body Mass Index (BMI) on sentinel lymph-node (SLN) detection. The primary study endpoint was to investigate the impact of obesity on overall detection rate, bilateral mapping, and mapping failure rate of SLN. In addition, we evaluated possible differences in terms of surgical management and "empty-packet dissection" rate among obese and non-obese patients. METHODS: Multicenter, propensity-matched, retrospective study. Patients with apparent early-stage endometrial cancer were included. Study population was divided into women with BMI

Anatomical distribution of sentinel lymph nodes in patients with endometrial cancer: a multicenter study.

OBJECTIVE: Sentinel lymph node (SLN) mapping represents the standard approach in uterine confined endometrial cancer patients. The aim of this study was to evaluate the anatomical distribution of SLNs and the most frequent locations of nodal metastasis. METHODS: This was an observational retrospective multicenter study involving eight high volume gynecologic cancer centers in Italy. We reviewed 1576 patients with a histologically confirmed diagnosis of endometrial cancer from September 2015 to June 2020. All patients underwent total hysterectomy with salpingo-ophorectomy and SLN mapping. RESULTS: A total of 3105 SLNs were mapped and removed, 2809 (90.5%) of these were bilateral and 296 (9.5%) unilateral. The overall detection rate was 93.4% (77.9% bilateral and 15.5% unilateral). The majority of SLNs (80%) and positive SLNs (77.8%) were found at the external iliac and obturator level in both endometrioid and non-endometrioid endometrial cancer. Negative SLNs were more frequent in patients with endometrioid compared with non-endometrioid cancer (91.9% vs 86.1%, p<0.0001). Older patients, a higher body mass index, and non-endometrioid histology were more likely to have 'no mapping' (p<0.0001). Univariate and multivariate analysis showed that higher body mass index and age at surgery were independent predictive factors of empty node packet and fat tissue (p=0.029 and p<0.01, respectively). CONCLUSION: The most frequent sites of SLNs and metastases were located in the pelvic area below the iliac vessel bifurcation. Our findings showed that older age, a higher body mass index, and non-endometrioid histology had a negative impact on mapping.

Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies: Results from a Large, Multicenter, Retrospective Analysis.

STUDY OBJECTIVE: Resection of bulky lymph nodes in gynecologic oncology is a challenging procedure. Considering the risk of intraoperative vascular injury, a technique to avoid severe complications is mandatory. In this study, we aimed to analyze the feasibility of laparoscopic ultraradical lymph node debulking using Yasargil clamps in patients with gynecologic cancer with bulky lymph node metastases. DESIGN: Multicenter retrospective case series (ClinicalTrialg.gov ID: NCT05318170), between September 2010 and April 2020. SETTING: Units of Gynecologic Oncology. PATIENTS: Patients with gynecologic cancer with bulky lymph node metastases. INTERVENTIONS: Laparoscopic ultraradical lymph node debulking using Yasargil clamps. MEASUREMENTS AND MAIN RESULTS: Forty-three patients with gynecologic cancer with bulky pelvic and/or aortic lymph nodes metastases undergoing laparoscopic lymph node debulking surgery using Yasargil clamps were included. Median surgical time was 300 minutes (range, 120-550 minutes); median estimated blood loss was 170 mL (range, 0-700 mL). Median size of lymph nodes was 50 mm (range, 25-100). R0 resection was achieved in all cases. Four intraoperative complications (9.3%) occurred. No conversion to open surgery was required. There were 8 postoperative complications, classified grade 2 or worse. There were no cases with intra- or postoperative mortality. CONCLUSION: In our experience, in carefully selected patients with gynecologic cancer with bulky lymph nodes, laparoscopic lymph node debulking using Yasargil clamps could be considered a valid option to avoid potential severe vascular intraoperative complications.

Nodal Assessment in Endometrial Atypical Hyperplasia.

OBJECTIVE: Atypical endometrial hyperplasia (AH) is the neoplastic precursor more often associated with endometrial cancer (EC). Nowadays, 25-50% of patients subjected to hysterectomy for preoperative AH are diagnosed with EC at the final pathological analysis. Furthermore, there is no consensus on which preoperative AH patients would benefit from sentinel lymph node mapping. This study aimed to evaluate nodal assessment and preoperative cancer risk factors in preoperative AH patients undergoing nodal surgical staging. METHODS: Patients undergoing surgical treatment for AH were retrospectively included in the analysis. Patients were divided into two groups (AH and EC groups) based on the final surgical pathology. The ESGO/ESTRO/ESP risk classification was used for EC cases. DESIGN: This was a retrospective study. RESULTS: Of the 207 AH patients treated, 152 cases met the inclusion criteria. Among preoperative AH patients with final EC diagnosis, 39 patients were in the low-risk group (25.7%), 8 in the intermediate-risk group (5.3%), 4 in high-intermediate (2.6%), and 3 patients were allocated in the high-risk group (2.0%). Fifty-four total patients underwent nodal surgical staging. Only one nodal micrometastasis (0.7%) was found at ultrastaging. Multivariate analysis showed abnormal uterine bleeding (AUB) (p = 0.01), hypertension (p < 0.01), and endometrial thickness ≥20 mm (p = 0.02) statistically more represented in patients with EC at final surgical analysis. EC risk was 2.9 (95% CI: 1.29-6.48) in AUB, 2.7 (95% CI: 1.06-6.92) in hypertension, and 3.1 (95% CI: 1.19-7.97) in endometrial thickness ≥20 mm cases. LIMITATIONS: The present study has limitations inherent in its retrospective nature. CONCLUSION: The overall risk of nodal metastases in preoperative AH patients was low. Conversely, 9.9% of the preoperative AH patients belonged to the intermediate or high-risk group for EC at the final histological examination. Preoperative cancer risk factors would identify AH patients for whom nodal staging could be suggested.

Retroperitoneal Squamous Cell Carcinoma Involving the Pelvic Side Wall Arising from Endometriosis: A Case Report.

INTRODUCTION: Squamous cell carcinoma (SCC) arising from endometriosis is very rare. Moreover, endometriosis located on the pelvic side wall is uncommon, while its cancerization is quite unusual. We herein report the first case of retroperitoneal SCC arising from endometriosis. CASE PRESENTATION: A case of a 52-year-old woman with retroperitoneal pararectal right mass is presented. The pelvic magnetic resonance imaging showed a retroperitoneal tumor extended to the right pelvic side wall. The neuropelveological examination completed the preoperative assessment, showing a right-sided sciatica and overactive bladder symptoms. Tumor removal was completely managed by a minimally invasive technique through the laparoscopic laterally extended endopelvic resection procedure and pelvic neurolysis. Final histology revealed a SCC in a context of diffuse endometriosis with a histologic continuity between the SCC and the endometriosis. The patient underwent adjuvant chemotherapy with no recurrence after 6 months. CONCLUSION: To the best of our knowledge, the present case represents the first evidence of retroperitoneal SCC of the pelvic side wall arising from endometriosis completely resected by laparoscopic approach. Although its rare occurrence, the gynecologist oncologist should maintain a high index of suspicion for malignant endometriosis transformation in case of retroperitoneal pelvic mass and history of endometriosis.

Surgical Neuropelviology: Combined Sacral Plexus Neurolysis and Laparoscopic Laterally Extended Endopelvic Resection in Deep Lateral Pelvic Endometriosis.

OBJECTIVE: Surgical demonstration of combined sacral plexus neurolysis and laparoscopic laterally extended endopelvic resection for deep lateral infiltrating endometriosis. DESIGN: Video showing principles of neurolysis and laparoscopic laterally extended endopelvic resection applied to endometriotic surgery. SETTING: University tertiary referral center. Deep infiltrating endometriosis is an underestimated disease with real medical and clinical issues, recently classified as central pelvic endometriosis and lateral pelvic endometriosis further divided into superficial and deep according to the structures' involvement [1]. The surgical removal of endometriotic foci remains the standard treatment. A wide knowledge of neuroanatomy and high skills in minimally invasive surgery are required to manage this challenging surgical scenario [2]. INTERVENTIONS: New surgical approach for deep lateral infiltrating endometriosis based on the principles of lateral extended endopelvic resection and neuropelviologic surgery [3,4]. The patient was a 35-year-old woman, para 1, with neuropathic pain radiating to the left leg and a cyclic menstrual disorder. A laparoscopically assisted neuronavigation and subsequent neurolysis allowed the identification of the lateral nodule without damage to the autonomic pelvic innervation [1]. Then, a complete resection of the internal vascular compartment was required to obtain a radical endometriotic eradication. Shaving and bladder resection were also performed to complete removal of the endometriotic foci. CONCLUSION: The association of neuroanatomic knowledge and surgical oncologic principles applied to minimally invasive surgery should be considered to ensure an adequate surgical radicality and clinical benefit in patients with deep infiltrating endometriosis.

Surgical Neuropelveology: Lateral Femoral Cutaneous Nerve Endometriosis. Laparoscopic Resection and Nerve Transplantation.

STUDY OBJECTIVE: To demonstrate the application of surgical neuroanatomic principles for the diagnosis and treatment of deep infiltrating endometriosis involving the lateral femoral cutaneous nerve. DESIGN: Video demonstration of laparoscopic lateral femoral cutaneous endometriosis resection with nerve transplant. SETTING: Endometriosis infiltrating somatic nerves is a poorly known condition, which can cause severe neuropathic symptoms [1] and is often unrecognized with a subsequent treatment delay [1]. Intimate knowledge of pelvic neuroanatomy and expertise in minimally invasive surgery are essential to manage this challenging surgical scenario [2-4]. INTERVENTIONS: Thirty-six years old patient with primary infertility and chronic pelvic pain associated with dysmenorrhea, dyspareunia, dysuria, and dyschezia. Preoperative magnetic resonance imaging detected a 3-cm parauterine and a 2-cm retrocervical endometriosis nodule. Magnetic resonance imaging did not demonstrate pelvic nerve involvement. Preoperative neuropelveologic assessment demonstrated a significant hypoesthesia of the corresponding lateral femoral cutaneous nerve dermatome, representing the primary complaint. A swab test showed spotting areas of allodynia. These findings prompted us to investigate for a right lateral femoral cutaneous entrapment. Laparoscopy showed an endometriosis nodule infiltrating the right lateral femoral cutaneous nerve. A resection of the nerve was necessary, and a subsequent reconstruction with a collagen bovine neuro-guide was carried out. The operative time was 300 minutes, and the estimated blood loss was 150 mL. Hospital stay was 3 days. After 3 months, the patient showed a clinical improvement in the pain and hypoesthesia on the reconstructed nerve dermatome. CONCLUSION: Neuropelvic anatomic assessment should be considered during the preoperative evaluation for patients with endometriosis who have pelvic pain and neuropathy as part of the diagnostic process [5]. This unique case demonstrates that nerve resection and transplantation can be used in specific situations for neuropathy related to deep infiltrative endometriosis of pelvic nerves.

Confounding factors of transvaginal ultrasound accuracy in endometrial cancer.

Endometrial cancer is the most frequently diagnosed gynecological tumour. Transvaginal ultrasound has a leading role in the preoperative evaluation of endometrial cancer patients. The study aimed to identify factors that can worsen the diagnostic accuracy of transvaginal ultrasound in endometrial cancer patients. We retrospectively analysed 290 patients with histological diagnosis of endometrial adenocarcinoma. Two-dimensional (2D) gray-scale ultrasound and power Doppler imaging were performed. Age, menopause status, obesity, parity, Figo stage and benign uterine disorders were evaluated as possible factors worsening the diagnostic accuracy of the ultrasonography. FIGO stage IB was the main significant confounding factor in the univariate analysis (p = .004). Furthermore, 2D transvaginal ultrasound showed worse diagnostic accuracy in endometrial cancer patients with concomitant benign uterine pathologies.Impact statementWhat is already known on this subject? Many studies have analysed the reliability and diagnostic accuracy of transvaginal ultrasound in predicting myometrial invasion, but few studies have underlined the importance of confounding factors. Shin et al. (2011) showed that diffuse fibromatosis is a quality ultrasound confounding factor. Furthermore, Fischerova et al. (2014) showed that body mass index (BMI) did not influence the diagnostic accuracy of ultrasound assessment.What do the results of this study add? FIGO stage IB is the main factor worsening the diagnostic accuracy of transvaginal ultrasound in endometrial cancer patients (p = .004). Among the 82 patients with histologically proven FIGO stage IB, 27 (32.9%) had a wrong ultrasound prediction of myometrial infiltration. Twenty-one (36.2%) patients in whom there was no agreement between ultrasound prediction of myometrial infiltration and pathological analysis had fibromatosis and/or adenomyosis (p = 0.04).What are the implications of these findings for clinical practice and/or further research? Two-dimensional ultrasound represents a useful tool in the correct pre-operative setting of patients with endometrial cancer. In FIGO stages IB endometrial cancer patients and in conjunction with benign uterine pathologies, 2D transvaginal ultrasound has less diagnostic accuracy. In these cases, MRI still plays a leading role.

Laparoscopic laterally extended endopelvic resection procedure for gynecological malignancies.

OBJECTIVES: Pelvic side wall infiltration by gynecological malignancies has been considered for a long time an absolute contraindication to curative resection. The development of the laterally extended endopelvic resection (LEER) has challenged this surgical paradigm. Although the LEER has been standardized in open surgery, only small studies have been published about its endoscopic feasibility. The objective of this study is to analyze the safety of LEER in patients with gynecological malignancies involving the pelvic side wall. METHODS: We retrospectively evaluated a consecutive series of patients who underwent a laparoscopically modified LEER between July 2014 and November 2018. This indicated gynecological tumors involving the pelvic sidewall and surgeries were conducted in two Italian institutions. All patients underwent pre-operative CT scan or PET to evaluate for distant metastases. Patients without suspicioun of distant metastasis underwent pelvic MRI and examination under anesthesia to establish the resectability of the disease and concomitant diagnostic laparoscopy to exclude intraperitoneal dissemination. All women with disease-free interval <6 months, and/or performance status >2 ECOG were excluded. Type of resection was defined based on the status of the pathologic margins: R0, microscopically negative (free margin <5 mm); R1, microscopically positive; and R2, macroscopically (grossly) positive. Disease-free survival was calculated from the date of primary surgery to the time of recurrence. Overall survival was defined as the time from primary surgery to death. RESULTS: Overall, 39 patients underwent a laparoscopic LEER and 18 (46.2%) patients were eligible for a laparoscopic approach. Laparoscopic LEER was performed as primary treatment for newly diagnosed tumors in eight patients (44.4%), and for recurrences in the other 10 patients (55.6%). No laparotomic conversions were registered. R0 resection was achieved with negative margins in all patients. The median operative time was 415 min (range, 285-615), median estimated blood loss was 285 mL (range, 100-600), and the median length of hospital stay was 10 days (range; 4-22). Only four patients (22.2%) needed blood intraoperative transfusion. In seven patients (38.9%), post-operative admission to intensive care unit was required. There were three (16.7%) intraoperative complications, all managed laparoscopically. In total there were six (33.3%) major postoperative complications: three patients (16.7%) experienced moderate hydronephrosis with normal renal function, which required temporary placement of nephrostomy; one patient (5.6%) had permanent urinary retention; and two patients (11.1%) had a reoperation, one for post-operative hemoperitoneum and another for complete vaginal cuff dehiscence. DISCUSSION: Laparoscopic LEER can be safely performed by experienced laparoscopic surgeons, in carefully selected patients with gynecological malignancies involving the lateral pelvic side wall, even for those in which a bladder and rectum sparing surgery appears possible. Further larger prospective trials are needed to evaluate the oncological and the long-term functional outcomes.

Laparoscopic sentinel node mapping with intracervical indocyanine green injection for endometrial cancer: the SENTIFAIL study - a multicentric analysis of predictors of failed mapping.

OBJECTIVES: Laparoscopy 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. METHODS: We 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. RESULTS: A 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. CONCLUSION: Lymph 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.

Novel preoperative predictive score to evaluate lymphovascular space involvement in endometrial cancer: an aid to the sentinel lymph node algorithm.

INTRODUCTION: Sentinel lymph node (SLN) dissection has been recognized as a valid tool for staging in patients with endometrial cancer. Several factors are predictors of recurrence and survival in endometrial cancer, including positive lymphovascular space invasion. The aim of this study is to formulate a pre-operative score that, in the event of no-SLN identification, may give an estimate of the true probability of lymphovascular space invasion and guide management. METHODOLOGY: This was a multi-institutional retrospective study conducted from January 2007 to December 2017. We included all patients with any grade endometrial tumor with a complete pathological description of the surgical specimen and with a minimum follow-up of 12 months. All patients underwent a class A hysterectomy according to Querleu and Morrow and bilateral salpingo-oophorectomy. Lymphadenectomy was performed based on patient risk of node metastases. In order to verify the predictive capacity of the parameters associated with lymphovascular space invasion status, grading, abnormal CA125 (>35 units/ml), myometrial invasion, and tumor size, a synthetic score was calculated. The score was introduced in the receiver operating characteristic curve model in which the binary classifier was represented by the lymphovascular space invasion status. The ideal cut-off was calculated with the determination of the Youden index. Sensitivity and negative predictive value of lymphovascular space invasion score was calculated in patients with lymph node metastasis. RESULTS: Six hundred and fourteen patients were included in the study. The average age and BMI of patients were 64.8 (range 33-88) years and 30.1 (range 17-64) respectively. Of the 284 patients who underwent lymphadenectomy, 231 (81.3%) patients had no lymph node metastases, 33 (11.6%) patients had metastatic pelvic lymph nodes, 12 (4.2%) patients had metastatic aortic lymph nodes, and eight (2.8%) patients had both pelvic and aortic metastatic lymph nodes. Lymphovascular space invasion was associated with deep myometrial infiltration (P<0.001), G3 grading (P<0.001), tumor size ≥25 mm (P=0.012), abnormal CA125 (P<0.001), recurrence (P<0.001), overall survival (P<0.001), and disease-free survival (P<0.01). Of all patients with lymphovascular space invasion, 79% had an lymphovascular space invasion score ≥5. The score ranged from a minimum score of 1 to a maximum of 7. The score shows 78.9% sensitivity (95% CI 0.6971 to 0.8594), 65.3% specificity (95% CI 0.611 to 0.693), 29.4% positive predictive value (95% CI 0.241 to 0.353), and 94.4% negative predictive value (95% CI 0.916 to 0.964). CONCLUSION: We found that when lymphovascular space invasion score ≤4, there is a very low possibility of finding lymph nodal involvement. The preoperative lymphovascular space invasion score could complement the SLN algorithm to avoid unnecessary lymphadenectomies.

Integrated pre-surgical diagnostic algorithm to define extent of disease in cervical cancer.

OBJECTIVES: Survival of patients with cervical cancer is strongly associated with the local extent of the primary disease. The aim of the study was to develop an integrated diagnostic algorithm, including ultrasonography (USG), magnetic resonance imaging (MRI), and examination under anesthesia, to define the local extent of disease in patients with newly diagnosed cervical cancer. METHODS: Patients with biopsy proven cervical cancer who underwent primary surgery from January 2013 to December 2018 in four participating centers were recruited. Patients who underwent USG, MRI, and examination under anesthesia prior to surgery were included in the study. Those for whom complete data were not available were excluded. Data regarding tumor size, parametrial invasion, and vaginal involvement obtained by USG, MRI, and examination under anesthesia were retrieved and compared with final histology. Specificity and sensitivity of the three methods were calculated for each parameter and the methods were compared with each other. An integrated pre-surgical algorithm was constructed considering the accuracy of each diagnostic method for each parameter. RESULTS: A total of 79 consecutive patients were included in the study. Median age was 53 years (range 28-87) and median body mass index was 24.6 kg/m2 (range 16-43). Fifty-five (69.6%) patients had squamous carcinoma, 18 (22.8%) patients had adenocarcinoma, and six (7.6%) patients had other histological subtypes. A statistically significant difference among the three methods was found for detecting tumor size (p=0.002 for tumors >2 cm and p=0.006 for tumors >4 cm) and vaginal involvement (p=0.01). There was no difference in detection of parametrial invasion between USG, MRI, and examination under anesthesia (p=0.26). Furthermore, regarding tumor size assessment, USG was found to be the significantly better method (p<0.01 for tumors >2 cm and p=0.02 for tumors >4 cm). Examination under anesthesia was the most accurate method for detection of vaginal involvement (p=0.01). Examination under anesthesia and MRI had higher accuracy than USG for identification of parametrial invasion. Application of the algorithm provided the correct definition of local extent of disease in 77.2% of patients (p=0.04). USG was the most accurate method to determine tumor size, while examination under anesthesia was found to be more accurate in prediction of vaginal involvement. CONCLUSION: Our integrated diagnostic algorithm allows a higher accuracy in defining the local extent of disease and may be used as a tool to determine the therapeutic approach in women with cervical cancer.

Risk factors associated with adverse fetal outcomes in pregnancies affected by Coronavirus disease 2019 (COVID-19): a secondary analysis of the WAPM study on COVID-19.

Objectives To evaluate the strength of association between maternal and pregnancy characteristics and the risk of adverse perinatal outcomes in pregnancies with laboratory confirmed COVID-19. Methods Secondary analysis of a multinational, cohort study on all consecutive pregnant women with laboratory-confirmed COVID-19 from February 1, 2020 to April 30, 2020 from 73 centers from 22 different countries. A confirmed case of COVID-19 was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite adverse fetal outcome, defined as the presence of either abortion (pregnancy loss before 22 weeks of gestations), stillbirth (intrauterine fetal death after 22 weeks of gestation), neonatal death (death of a live-born infant within the first 28 days of life), and perinatal death (either stillbirth or neonatal death). Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). Results Mean gestational age at diagnosis was 30.6±9.5 weeks, with 8.0% of women being diagnosed in the first, 22.2% in the second and 69.8% in the third trimester of pregnancy. There were six miscarriage (2.3%), six intrauterine device (IUD) (2.3) and 5 (2.0%) neonatal deaths, with an overall rate of perinatal death of 4.2% (11/265), thus resulting into 17 cases experiencing and 226 not experiencing composite adverse fetal outcome. Neither stillbirths nor neonatal deaths had congenital anomalies found at antenatal or postnatal evaluation. Furthermore, none of the cases experiencing IUD had signs of impending demise at arterial or venous Doppler. Neonatal deaths were all considered as prematurity-related adverse events. Of the 250 live-born neonates, one (0.4%) was found positive at RT-PCR pharyngeal swabs performed after delivery. The mother was tested positive during the third trimester of pregnancy. The newborn was asymptomatic and had negative RT-PCR test after 14 days of life. At logistic regression analysis, gestational age at diagnosis (OR: 0.85, 95% CI 0.8-0.9 per week increase; p<0.001), birthweight (OR: 1.17, 95% CI 1.09-1.12.7 per 100 g decrease; p=0.012) and maternal ventilatory support, including either need for oxygen or CPAP (OR: 4.12, 95% CI 2.3-7.9; p=0.001) were independently associated with composite adverse fetal outcome. Conclusions Early gestational age at infection, maternal ventilatory supports and low birthweight are the main determinants of adverse perinatal outcomes in fetuses with maternal COVID-19 infection. Conversely, the risk of vertical transmission seems negligible.

Incidence, predictors and clinical outcome of pancreatic fistula in patients receiving splenectomy for advanced or recurrent ovarian cancer: a large multicentric experience.

PURPOSE: To evaluate the incidence, predictors and clinical outcome of pancreatic fistulas in patients receiving splenectomy during cytoreductive surgery for advanced or recurrent ovarian cancer. METHODS: Data of women who underwent splenectomy during cytoreduction for advanced or recurrent ovarian cancer from December 2012 to May 2018 were retrospectively retrieved from the oncological databases of five institutions. Surgical, post-operative and follow-up data were analysed. RESULTS: Overall, 260 patients were included in the study. Pancreatic resection was performed in 45 (17.6%) women, 23 of whom received capsule resection alone, while 22 required tail resection. Hyperthermic intraperitoneal chemotherapy (HIPEC) was administered in 28 (10.8%) patients. In the overall population, a pancreatic fistula was detected in 32 (12.3%) patients, and pancreatic resection (p-value = 0.033) and HIPEC administration (p-value = 0.039) were associated with fistula development. In multivariate analysis, HIPEC (OR = 2.573; p-value = 0.058) was confirmed as a risk factor for fistula development in women receiving splenectomy alone, while concomitant cholecystectomy (OR = 2.680; p-value = 0.012) was identified as the only independent predictor of the occurrence of pancreatic fistulas in those receiving additional distal pancreatectomy. Although the median length of hospital stay was higher in women with pancreatic leakage (p-value = 0.008), the median time from surgery to adjuvant treatment was not significantly increased. CONCLUSION: HIPEC was identified as a risk factor for pancreatic fistulas in patients who underwent splenectomy alone, while concomitant cholecystectomy was the only independent predictor of fistula in those receiving additional pancreatectomy. The development of pancreatic leakage was not associated with increased post-operative mortality or delay in the initiation of chemotherapy.

Endoscopic near infrared and indocyanine green to verify the viability of the subcutaneous flap for vulvar cancer.

INTRODUCTION: Vulvar cancer often requires radical vulvectomy with subsequent vulvar flap. Approximately in 20-60% of cases, there are post-operative complications ranging from infection to flap necrosis that often require reoperation. Several methods have been described to verify the vitality of the flap, but these are often expensive and require specific machinery that is not generally present in a gynecological clinic. In this case report, we present a viability verification of VY fasciocutaneous advancement flap for vulvar reconstruction by Endoscopic Near-Infrared and Indocyanine Green. METHODOLOGY: The patient was a 67-year-old woman with FIGO IB ≤ 4 cm squamous cell vulvar cancer with absence of inguinal lymphadenopathy. The lesion appeared about 35 mm from the lateral margin of the large left lip and extended to the left inguinocrural fold. The patient underwent left inguinal lymphadenectomy and left radical hemivulvectomy with a left fasciocutaneous medial-thigh advancement flap. For the flap evaluation, we endovenous administered 50 mg of Indocyanine Green diluted in 10 ml of saline solution. After 10 min we visualized the flap margin with a near-infrared laparoscopic view. The evaluation was repeated at the end of the surgical procedure and we confirmed the good vascularization of the flap. RESULTS: No early or late post-operative complications were obtained. There was no wound dehiscence, marginal necrosis or surgical site infection. CONCLUSIONS: Verifying the viability of the vulvar flap using near-infrared laparoscopic optics was easy to use, reproducible and highly economical technique. This could be a reproducible alternative to other more expensive techniques.