Laparoscopic en-bloc pelvic resection for advanced ovarian cancer.

Introduction: Ovarian cancer (OC) exhibits an aggressive behavior, wherein the therapeutic approach always involves both surgery and chemotherapy. Survival outcomes are still related to comprehensive surgical excision of all macroscopic lesions (Rauh-Hain et al., 2017), increasing gynecologic oncologists' efforts to achieve the highest possible complete resection rate (Tozzi et al., 2024). The peritoneum serves as both a dissemination pathway and a barrier that restricts tumor spread beyond its confines. This understanding has prompted the adoption of en-bloc resection strategy for the entire pelvis, involving the removal of pelvic organs along with the surrounding peritoneum. The en-bloc pelvic resection procedure allows for the removal of pelvic disease in all cases of advanced ovarian cancer (Tozzi et al., 2017).Endeavors should be also directed towards minimizing surgical morbidity, by the adoption of minimally invasive surgery for debulking procedures (Tozzi et al., 2023). Case: This video demonstrates a laparoscopic en-bloc pelvic resection with creation of an end-to-end transanal anastomosis. The surgical specimen extraction and the placement of the anvil were performed through the vaginal route.A 75 year-old patient presented with FIGO stage IIIC OC with a 12 cm pelvic mass involving the whole pelvis. The patient was enrolled in the ULTRA-LAP trial and underwent laparoscopic primary debulking surgery with en-bloc pelvic resection. No protective ileostomy was performed and bowel opening occurred on the fifth postoperative day. The patient was discharged on the 11th postoperative day, thereafter completing a regimen of 6 cycles of carboplatin and paclitaxel chemotherapy. Conclusions: The en-bloc resection of the pelvis is a standardized procedure that consists of ten reproducible steps.

An Ultrasound-Based Preoperative Evaluation of the Endometriosis Fertility Index: A Further Step towards Personalized Treatment.

Background: The Endometriosis Fertility Index (EFI), is a crucial validated surgical tool used for predicting fertility outcomes in women with endometriosis. This study aims to assess the concordance between a preoperative clinical and instrumental EFI evaluation (uEFI) and the EFI score obtained during an exploratory laparoscopy prior to surgery (sEFI). Methods: This study presents preliminary data from a broader observational cohort study. The Least Function score for the uEFI was calculated using a modified version of the original surgical EFI by incorporating a clinical examination, advanced ultrasound, and hysterosalpingo-foam sonography (HyFoSy). Results: The preoperative estimation of the EFI (uEFI) demonstrated a high concordance (k = 0.695, ρs = 0.811) with the sEFI. Remarkably, the surgical interventions led to a significant improvement in the EFI values, with 80% of the intermediate EFI transitioning to a high level, thereby highlighting the positive impact of surgery on fertility outcomes. Conclusion: This study highlights the accuracy of preoperative EFI estimation (uEFI) and its strong agreement with intraoperative assessment. It underscores the potential of a preoperative management tool to guide the allocation of infertile women with endometriosis to operative laparoscopy, direct assisted reproductive technology (ART), or spontaneous attempts at pregnancy.

Peritonectomy and resection of mesentery during Visceral-Peritoneal Debulking (VPD) in patients with stage IIIC-IV ovarian cancer: A phase I-II trial.

OBJECTIVE: To describe the surgical technique, assess feasibility, efficacy, and safety of peritonectomy and/or resection of mesentery (P-Rme) during Visceral-Peritoneal Debulking (VPD) in patients with stage IIIC-IV ovarian cancer (OC). METHODS: In April 2009 we registered a protocol study on the safety and feasibility of P-Rme. In the period April 2009-December 2022, 687 patients with FIGO stage IIIC-IV ovarian cancer underwent VPD. One hundred and twenty-nine patients (18.7%) had extensive disease on the mesentery and underwent P-Rme. Feasibility was assessed as the number of procedures completed. Efficacy was measured as the rate of Complete Resection (CR). Safety was defined by the intra- and post-operative morbidity rate specifically associated with these procedures. RESULTS: In all patients P-Rme was successfully completed. P-me was performed in 82 patients and R-me in 47, both procedures in 23 patients. CR was achieved in all 129 patients with an efficacy of 100%. Intra-operatively 5 patients out of 129 experienced small bowel loop surgical devascularization. They required small bowel resection and anastomosis. The procedure specific morbidity was 3.8%. No post-operative complication was related to P-Rme. At 64 months median follow-up, survival outcomes in the study group were similar to patients in the control group. CONCLUSION: Overall, almost 20% of the VPD patients needed P-Rme to obtain a CR. P-Rme was a safe and effective step during VPD. The rate of CR in the study group was 100% achieved thanks to the addition of the P-Rme. No procedure specific post-operative complications occurred but 3.8% of the patients had unplanned additional surgery related to these procedures.

Feasibility of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer: the ULTRA-LAP trial pilot study.

OBJECTIVE: A non-randomized prospective clinical trial (ULTRA-LAP) was registered to test safety, side effects and efficacy of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer (OC). A pilot study was designed to identify which OC patients are suitable to undergo L-VPD. METHODS: Between March 2016 and October 2021, all consecutive patients with OC underwent exploratory laparoscopy (EXL). All patients whose disease was deemed amenable for a complete resection (CR) at imaging review and EXL, underwent VPD. In all patients a consistent attempt was made at completing L-VPD. RESULTS: Two hundred and eight OC had EXL in the study period: 121 underwent interval VPD and 87 up-front VPD. Overall, 158 patients had VPD by laparotomy (75.9%) and 50 (24.1%) had L-VPD, of which 34 patients as interval (iL-VPD) and 16 as up-front (uL-VPD). Intra- and post-operative morbidity was very low in the L-VPD group. CR rate was 98% in L-VPD group and 94% in VPD. Most common reason for conversion was diaphragmatic disease extending dorsally. CONCLUSION: In the pilot study of ULTRA-LAP, L-VPD was completed in 24,1% of OC. Initial analysis supports the feasibility of L-VPD in 2 groups of OC: those with no gross disease at interval surgery and those with gross visible disease at upfront or interval surgery, but limited to: pelvis (including recto-sigmoid), gastro colic omentum, peritoneum and diaphragm, the latter not requiring dorsal liver mobilization. Both groups had 100% feasibility and have been thus forth recruited to ULTRA-LAP. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05862740.

MAGE-A10 Protein Expression in Advanced High Grade Serous Ovarian Cancer Is Associated with Resistance to First-Line Platinum-Based Chemotherapy.

Ovarian cancer has a dismal prognosis. Standard treatment following surgery relies on platinum-based chemotherapy. However, sizeable percentages of patients are unresponsive. Identification of markers predicting the response to chemotherapy might help select eligible patients and spare non-responding patients from treatment-associated toxicity. Cancer/testis antigens (CTAs) are expressed by healthy germ cells and malignant cells of diverse histological origin. This expression profile identifies them as attractive targets for cancer immunotherapies. We analyzed the correlations between expression of MAGE-A10 and New York esophageal-1 cancer (NY-ESO-1) CTAs at the protein level and the effectiveness of platinum-based chemotherapy in patients with advanced-stage high-grade serous ovarian carcinoma (HGSOC). MAGE-A10 and NY-ESO-1 protein expression was analyzed by immunohistochemistry (IHC) in formalin-fixed, paraffin-embedded samples from 93 patients with advanced-stage HGSOC treated at our institutions between January 1996 and December 2013. The correlation between the expression of these markers and response to platinum-based chemotherapy, evaluated according to RECIST 1.1 criteria and platinum sensitivity, measured as platinum-free interval (PFI), progression free (PFS), and overall survival (OS) was explored. The MAGE-A10 protein expression predicted unresponsiveness to platinum-based chemotherapy (p = 0.005), poor platinum sensitivity (p < 0.001), poor PFS (p < 0.001), and OS (p < 0.001). Multivariate analysis identified MAGE-A10 protein expression as an independent predictor of poor platinum sensitivity (p = 0.005) and shorter OS (p < 0.001). Instead, no correlation was observed between the NY-ESO-1 protein expression and response to platinum-based chemotherapy (p = 0.832), platinum sensitivity (p = 0.168), PFS (p = 0.126), and OS (p = 0.335). The MAGE-A10 protein expression reliably identified advanced-stage HGSOC unresponsive to platinum-based chemotherapy. Targeted immunotherapy could represent an important alternative therapeutic option in these cancers.

Simple rules, O-RADS, ADNEX and SRR model: Single oncologic center validation of diagnostic predictive models alone and combined (two-step strategy) to estimate the risk of malignancy in adnexal masses and ovarian tumors.

OBJECTIVE: To compare performance of Assessment of Different NEoplasias in the adneXa (ADNEX model), Ovarian-Adnexal Reporting and Data System (O-RADS), Simple Rules Risk (SRR) assessment and the two-step strategy based on the application of Simple Rules (SR) followed by SRR and SR followed by ADNEX in the pre-operative discrimination between benign and malignant adnexal masses (AMs). METHODS: We conducted a retrospective study from January-2018 to December-2021 in which consecutive patients with at AMs were recruited. Accuracy metrics included sensitivity (SE) and specificity (SP) with their 95% confidence intervals (CI) were calculated for ADNEX, O-RADS and SRR. When SR was inconclusive a "two-step strategy" was adopted applying SR + ADNEX model and SR + SRR assessment. RESULTS: A total of 514 women were included, 400 (77.8%) had a benign ovarian tumor and 114 (22.2%) had a malignant tumor. At a threshold malignancy risk of >10%, the SE and SP of ADNEX model, O-RADS and SRR were: 0.92 (95% CI, 0.86-0.96) and 0.88 (95% CI, 0.85-0.91); 0.93 (95% CI, 0.87-0.97) and 0.89 (95% CI, 0.96-0.92); 0.88 (95% CI, 0.80-0.93) and 0.84 (95% CI, 0.80-0.87), respectively. When we applied SR, 109 (21.2%) cases resulted inconclusive. The SE and SP of two-step strategy SR + SRR assessment and SR + ADNEX model were 0.88 (95% CI, 0.80-0.93) and 0.92 (95% CI, 0.89-0.94), SR + ADNEX model 0.90 (95% CI, 0.83-0.95) and 0.93 (95% CI, 0.90-0.96), respectively. CONCLUSIONS: O-RADS presented the highest SE, similar to ADNEX model and SR + ADNEX model. However, the SR + ADNEX model presented the higher performance accuracy with the higher SP and PPV. This two-step strategy, SR and ADNEX model applicated to inconclusive SR, is convenient for clinical evaluation.

Patient Derived Organoids (PDOs), Extracellular Matrix (ECM), Tumor Microenvironment (TME) and Drug Screening: State of the Art and Clinical Implications of Ovarian Cancer Organoids in the Era of Precision Medicine.

Ovarian cancer (OC) has the highest mortality rate of all gynecological malignancies due to the high prevalence of advanced stages of diagnosis and the high rate of recurrence. Furthermore, the heterogeneity of OC tumors contributes to the rapid development of resistance to conventional chemotherapy. In recent years, in order to overcome these problems, targeted therapies have been introduced in various types of tumors, including gynecological cancer. However, the lack of predictive biomarkers showing different clinical benefits limits the effectiveness of these therapies. This requires the development of preclinical models that can replicate the histological and molecular characteristics of OC subtypes. In this scenario, organoids become an important preclinical model for personalized medicine. In fact, patient-derived organoids (PDO) recapture tumor heterogeneity with the possibility of performing drug screening. However, to best reproduce the patient's characteristics, it is necessary to develop a specific extracellular matrix (ECM) and introduce a tumor microenvironment (TME), which both represent an actual object of study to improve drug screening, particularly when used in targeted therapy and immunotherapy to guide therapeutic decisions. In this review, we summarize the current state of the art for the screening of PDOs, ECM, TME, and drugs in the setting of OC, as well as discussing the clinical implications and future perspectives for the research of OC organoids.

Vaginal-Laparoscopic Repair (VLR) of Primary and Persistent Vesico-Vaginal Fistula: Description of a New Technique and Surgical Outcomes.

The main aim of our study was to describe the surgical technique and evaluate the feasibility, efficacy and safety of a vaginal-laparoscopic repair (VLR) of iatrogenic vesico-vaginal fistulae (VVF). Between April-2009 and November-2017, we retrospectively reviewed all clinical, radiological and surgical details of surgery for benign or malignant disease and ended up with VVF. All patients were diagnosed by CT urogram, cystogram and clinical test. The surgical technique was standardised and is described here. Eighteen patients developed VVF after hysterectomy, three after caesarean section and three after hysterectomy and pelvic lymphadenectomy. Twenty-two patients had an average 3 (range 1-5) attempts at fistula repair in other hospitals. In one patient, five attempts were made. The mean size of the fistula was 2.4 cm (range 0.7-3.1 cm). A median 8 weeks (6-16) conservative management with Foley catheter failed in all patients. No conversion to laparotomy and no complication occurred at VLR. Median hospitalisation was 1.4 days (range 1-3). The latter confirmed all patients were dry and tested negative at a repeated filling test. At 36 months follow-up, all patients remained dry. In conclusion, VLR successfully repaired VVF in all patients with primary and persistent VVF. The technique was safe and effective.

Comparison end-to-end anastomosis with ostomy after secondary surgical cytoreduction for recurrent high-grade serous ovarian cancer: observational single-center study.

We conducted an observational single-center cohort study on patients with recurrent high-grade serous ovarian carcinoma that underwent secondary surgical cytoreduction with extent of partial ileectomy and/or colectomy, followed by adjuvant chemotherapy (Paclitaxel-Carboplatin). All patients performed previously primary debulking surgery without residual disease, followed by three cycles of adjuvant chemotherapy. The aim of this study was to compare survival in patients with ostomy or end-to-end anastomosis that underwent secondary cytoreduction. Furthermore, we investigated the morbidity, the rate, timing and complications of the ostomy or end-to-end anastomosis after secondary cyto-reduction.

Risk-Reducing Salpingo-Oophorectomy (RRSO) Combined with Simultaneous Mastectomy in Women with BRCA 1-2 Mutation Carriers: The Surgical Technique, the Feasibility and Patients' Satisfaction of Multiple Surgeries.

The main goal of our study was to evaluate the surgical technique, the feasibility and patient's satisfaction of multiple surgeries: Risk-reducing salpingo-oophorectomy (RRSO) combined with mastectomy in patients with BRCA 1-2 mutation carriers. We conducted a retrospective analysis of patients with BRCA 1-2 variants who underwent RRSO combined with risk-reducing bilateral mastectomy (RRBM) or surgeries for breast cancer from January-2015 to December-2021. We collected data about surgeries, complications, and patients' satisfaction using a questionnaire submitted 30 days after surgery. We included 54 patients. Forty-eight patients underwent RRSO, and six patients underwent RRSO + Total laparoscopic hysterectomy (LTH). The minor postoperative complications within 30 days were four: one breast seromas aspiration (1.9%), one infectious reconstructive complication treated with antibiotics therapy (1.9%), one Red-Breast-Syndrome (1.9%) and one trocar abdominal hematoma (1.9%) associated with RRSO. The major postoperative complications within 30 days were five: two evacuations of a breast hematoma (3.7%) and three infectious reconstructive complications treated with removal expander/implant (5.6%). No postoperative complications after 30 days were observed. According to the satisfaction questionnaire, more than 90% of patients were satisfied and would have combined surgery again. In conclusion, the multiple surgeries seem feasible and safety with a single anesthesia, a single surgical time, a single postoperative recovery, and a high patients' satisfactions without increasing morbidity.

Uterine Septum with or without Hysteroscopic Metroplasty: Impact on Fertility and Obstetrical Outcomes-A Systematic Review and Meta-Analysis of Observational Research.

Objective: we performed a systematic review/meta-analysis to evaluate the impact of septate uterus and hysteroscopic metroplasty on pregnancy rate-(PR), live birth rate-(LBR), spontaneous abortion-(SA) and preterm labor (PL) in infertile/recurrent miscarriage-(RM) patients. Data sources: a literature search of relevant papers was conducted using electronic bibliographic databases (Medline, Scopus, Embase, Science direct). Study eligibility criteria: we included in this meta-analysis all types of observational studies that evaluated the clinical impact of the uterine septum and its resection (hysteroscopic metroplasty) on reproductive and obstetrics outcomes. The population included were patients with a diagnosis of infertility or recurrent pregnancy loss. Study appraisal and synthesis methods: outcomes were evaluated according to three subgroups: (i) Women with untreated uterine septum versus women without septum (controls); (ii) Women with treated uterine septum versus women with untreated septum (controls); (iii) Women before and after septum removal. Odds ratios (OR) with 95% confidence intervals (CI) were calculated for the outcome measures. A p-value < 0.05 was considered statistically significant. Subgroup analysis was performed according to the depth of the septum. Sources of heterogeneity were explored by meta-regression analysis according to specific features: assisted reproductive technology/spontaneous conception, study design and quality of papers included Results: data from 38 studies were extracted. (i) septum versus no septum: a lower PR and LBR were associated with septate uterus vs. controls (OR 0.45, 95% CI 0.27−0.76; p < 0.0001; and OR 0.21, 95% CI 0.12−0.39; p < 0.0001); a higher proportion of SA and PL was associated with septate uterus vs. controls (OR 4.29, 95% CI 2.90−6.36; p < 0.0001; OR 2.56, 95% CI 1.52−4.31; p = 0.0004). (ii) treated versus untreated septum: PR and PL were not different in removed vs. unremoved septum(OR 1.10, 95% CI 0.49−2.49; p = 0.82 and OR 0.81, 95% CI 0.35−1.86; p = 0.62); a lower proportion of SA was associated with removed vs. unremoved septum (OR 0.47, 95% CI 0.21−1.04; p = 0.001); (iii) before-after septum removal: the proportion of LBR was higher after the removal of septum (OR 49.58, 95% CI 29.93−82.13; p < 0.0001) and the proportion of SA and PL was lower after the removal of the septum (OR 0.02, 95% CI 0.02−0.04; p < 0.000 and OR 0.05, 95% CI 0.03−0.08; p < 0.0001) Conclusions: the results show the detrimental effect of the uterine septum on PR, LBR, SA and PL. Its treatment reduces the rate of SA.

New Light on Endometrial Thickness as a Risk Factor of Cancer: What Do Clinicians Need to Know?

Transvaginal ultrasound (TVUS) represents an accurate and noninvasive technique to investigate endometrial thickness (ET) in the early diagnosis of endometrial cancer (EC). In the literature, for maximum ET there is no consensus on the cutoff value for normal ET in postmenopause for either symptomatic or asymptomatic women. Most patients with EC present with postmenopausal bleeding (PMB) and in these patients is necessary to perform TVUS to evaluate ET as an indicator for endometrial biopsy. On the contrary, if ET is incidentally detected in postmenopausal patients without bleeding, endometrial sampling for a postmenopausal woman without bleeding should not be routinely performed, although it is estimated that up to 15% of EC occurs in women without vaginal bleeding. The aim of our review was to give clinicians necessary and useful knowledge on the role of TVUS and ET for early detection of EC in their daily routine practice. Based on the most important studies in the literature, we summarized that in premenopausal woman with abnormal uterine bleeding, an optimal cutoff for ET has not yet been established. For postmenopausal women with PMB, at low risk, and ET <4 mm, a follow-up scan could be offered, and for women with ET ≥4 mm, office hysteroscopy-guided endometrial sampling is recommended independently of ET results. On the other hand, in postmenopausal women with PMB and at high risk of EC, office hysteroscopy-guided endometrial sampling is necessary. In postmenopausal women without PMB and ET ≥4 mm, arbitrary endometrial sampling is not recommended, but evaluated case by case based on risk factors. In conclusion, there is broad consensus on the importance of TVUS and the need for further investigation based on risk factors of EC.

Congenital Zika Syndrome: Genetic Avenues for Diagnosis and Therapy, Possible Management and Long-Term Outcomes.

Zika virus (ZIKV) was discovered in Uganda in 1947 and was originally isolated only in Africa and Asia. After a spike of microcephaly cases in Brazil, research has closely focused on different aspects of congenital ZIKV infection. In this review, we evaluated many aspects of the disease in order to build its natural history, with a focus on the long-term clinical and neuro-radiological outcomes in children. The authors have conducted a wide-ranging search spanning the 2012-2021 period from databases PubMed, PubMed Central, Web of Science, Medline, Scopus. Different sections reflect different points of congenital ZIKV infection syndrome: pathogenesis, prenatal diagnosis, clinical signs, neuroimaging and long-term developmental outcomes. It emerged that pathogenesis has not been fully clarified and that the clinical signs are not only limited to microcephaly. Given the current absence of treatments, we proposed schemes to optimize diagnostic protocols in endemic countries. It is essential to know the key aspects of this disease to guarantee early diagnosis, even in less severe cases, and an adequate management of the main chronic problems. Considering the relatively recent discovery of this congenital infectious syndrome, further studies and updated long-term follow-up are needed to further improve management strategies for this disease.

Efficacy of risk-reducing salpingo-oophorectomy in BRCA1-2 variants and clinical outcomes of follow-up in patients with isolated serous tubal intraepithelial carcinoma (STIC).

OBJECTIVE: Serous tubal intraepithelial carcinoma (STIC) is currently considered the precursor lesion of pelvic high-grade serous carcinoma. The management of STIC diagnosed after risk-reducing salpingo-oophorectomy (RRSO) in women with BRCA1-2 variants remains unclear. The aim of our study was to evaluate the incidence of STIC, serous tubal intraepithelial lesions (STIL) and occult invasive cancer (OC) and to determine the long-term outcomes of these patients. METHODS: We conducted a retrospective study of patients with BRCA 1-2 variants who underwent RRSO between January-2010 and Dicember-2020 at the Clinic of Gynaecology of University of Padova. INCLUSION CRITERIA: women with a negative pelvic examination at the last screening prior to RRSO, patients with fallopian tubes analysed using the SEE-FIM protocol. EXCLUSION CRITERIA: patients with a positive gynaecologic screening or with ovarian/tubal cancer prior to RRSO. RESULTS: We included 153 patients. STICs were diagnosed in 4 patients (2.6%) and STILs in 6 patients (3.9%). None of the patients with STIC underwent restaging surgery or adjuvant chemotherapy; all patients were followed closely every 6 months. None of the patients developed primary peritoneal carcinomas (PPCs) with a median FUP of 54.5 months (15-106). OC was diagnosed in 3 patients (2%). All patients with OC underwent staging surgery, and one patient developed a peritoneal carcinoma (PC) after 18 months by staging surgery. CONCLUSION(S): The incidence of STIC, STIL and OC after RRSO in BRCA1-2 variants was low. Our results demonstrated that long-term close surveillance in patients diagnosed with STIC should be considered a possible management strategy.

Effects of lateral episiotomy on the emergence of urinary incontinence during the first postpartum year in primiparas: prospective cohort study.

AIM OF THE STUDY: Lateral episiotomy is a widely used procedure, although it is rarely mentioned in the literature and its effects on the pelvic floor are largely unexplored. The purpose of this study is to evaluate the impact of lateral episiotomy on the incidence of urinary incontinence (UI) after vaginal delivery in primiparas. MATERIAL AND METHODS: The study design is a prospective cohort study. The primiparas were divided into two groups. The first group consisted of women who gave birth with lateral episiotomy, while the second group included women who gave birth with an intact perineum or with perineal tears of first and second degree. Assessments of UI were performed at 5 and 8 months after childbirth using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) questionnaire followed by the stress test. RESULTS: The results revealed no significant differences (p > 0.05) in emergence of stress urinary incontinence (SUI) between the groups at the two time points. There were no statistically significant differences in overall rate of UI, urge urinary incontinence (UUI), or mixed urinary incontinence according to the ICIQ-SF questionnaire. The overall incontinence rate on the first examination was 24% in the episiotomy group and 36% in the perineal laceration group, although the difference was not statistically significant (p = 0.064). On the second examination, rates were similar and without a statistically significant difference. CONCLUSIONS: Lateral episiotomy has a neutral effect on the onset of UI in primiparous women in the first year after delivery.

A retrospective study of endobronchial ultrasound transbronchial needle aspiration versus conventional transbronchial needle aspiration in diagnosis/staging of hilar/mediastinal lymph node in lung cancer: Which role in clinical practice?

The conventional-trans bronchial needle aspiration (c-TBNA) has been the first procedure for sampling hilar/mediastinal lymph node for the diagnosis/staging of lung cancer. In the last decade the endobronchial ultrasound trans bronchial needle aspiration (EBUS-TBNA) was introduced in clinical practice and became the first-choice exam in diagnosis and staging of lung cancer. The aim of this study was to compare the diagnostic accuracy (DA), sensitivity and adequacy of c-TBNA and EBUS-TBNA. It was a retrospective and observational multicenter study. The first endpoint was diagnostic accuracy of EBUS-TBNA versus c-TBNA. The secondary end-points were sensitivity and adequacy. Two hundred and nine consecutive patients underwent the procedure, 99 EBUS-TBNA and 110 c-TBNA. When lymph nodes with short axis <2 cm the diagnostic accuracy for correct diagnosis was 94.2% in EBUS-TBNA group and 89.7% in c-TBNA group (p=0.01); the sample adequacy was 70.3% and 42%, respectively (p=0.01); the sensitivity was 93% (95% CI, 82-98%) and 86.4% (95% CI, 67.6-95.6%), respectively (p=0.002). In lymph nodes with short axis ≥2 cm the diagnostic accuracy was 95.7% in EBUS-TBNA group and 93% in c-TBNA group (p=0.939); the sample adequacy was 68.7% and 68.3%, respectively (p=0.889); the sensitivity was 95.1% (95% CI, 83-99%) and 92.1%, respectively (95% CI, 78.7-97.7%) (p=0.898). The EBUS-TBNA in patients with lymph nodes size <2 cm presented a statistically significant difference in the DA, adequacy and sensitivity compared to c-TBNA procedure, while there were no significant differences in the DA, adequacy and sensitivity between EBUS-TBNA and c-TBNA in patients with lymph node size ≥2 cm. The results of our study indicated that the EBUS-TBNA should be the first-choice procedure for the diagnosis/staging in lung cancer patients with lymph node size <2 cm. In patients with lymph node size ≥2 cm, instead, both procedures can be used for the diagnosis/staging of lung cancer.

Deep sedation versus minimal sedation during endobronchial ultrasound transbronchial needle aspiration.

The sedation plays an important role in the endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) procedure. The sedation can be Minimal (anxiolysis), Moderate (conscious sedation) or Deep. The ACCP guidelines suggest that moderate or deep sedation (DS) is an acceptable approach. In fact, several studies compare moderate versus deep sedation, but no study has been carried out to compare deep sedation versus minimal. We carried out a retrospective study to compare the Deep versus Minimal sedation (MiS) in patients undergoing EBUS-TBNA.  The primary end point was the diagnostic accuracy. The secondary end points were adequacy and sensitivity. We evaluated the LN size sampling, procedural time, complications and patient tolerance. Thirty-six patients underwent EBUS-TBNA, 16 under DS and 20 under MiS. The overall diagnostic accuracy for correct diagnosis was 92.9% in DS group and 94.1% in MiS group (p=0.554). Sample adequacy, defined as the percentage of patients with a specific diagnosis by EBUS-TBNA, was 87.5% (14 of 16) and 85% (17 of 20) for the DS group and MiS group, respectively, (p=0.788); the sensitivity was 92.9% in the DS group (95% CI, 73-100%) and 92.9% in the MiS group (95% CI, 77-100%) (p=0.463). There were no major complications in either group. Minor complications were 4 in MiS and 1 in DS (p=0.355).  The patients in the MiS group recalled the procedure more often compared to the other group (p=0.041). The majority of the patients would agree to undergo the same procedure again in the future in both groups (p=0.766).  In our experience EBUS-TBNA performed under MiS has comparable accuracy, adequacy, sensitivity, complications and patient satisfaction to DS, even if the sample was small.  Future prospective multicenter studies are needed to confirm our results.