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Nous avons comparé les résultats cliniques de l'infection à la Covid-19 parmi les personnels de la santé masculins et féminins, suivis pendant les trois premiers mois après l'épidémie de COVID-19 en Italie. La population étudiée était composée de 64 des 3585 travailleurs de la santé qui ont développé une infection au COVID-19. Les sujets qui ont signalé une dyspnée et/ou qui ont dû être hospitalisés ont été classés dans le groupe « maladie grave ». Les travailleurs de la santé qui ont signalé la présence de symptômes mineurs (comme fièvre, toux sèche, etc.) sans avoir besoin d’une hospitalisation ont été inclus dans le groupe « maladie bénigne ». Les personnels asymptomatiques à la COVID-19 étaient respectivement de 19 % et 25,6 % dans les groupes d'hommes et de femmes. Les hommes présentaient un taux plus élevé de symptômes graves (47.1%, Vs 15.6%). Aussi, parmi les travailleurs symptomatiques, les hommes ont eu besoin d'unehospitalisation plus fréquemment que les femmes (52.9% Vs 15.1%). Utilisant une régression logistique binaire, avec la prévalence de « symptômes graves » comme variable dépendante et « sexe » et « âge » comme variable indépendante, l’odds ratio H/F était égal à 4,8 (IC 1.247, 18.482), tandis que « âge » ne semblait pas avoir un rôle. Malgré les limites liées à la petite taille de la population étudiée, nos résultats confirment que les soignants hommes sont plus susceptibles que les femmes d'avoir des pires résultats cliniques.

Background The prevalence and incidence of obesity is alarmingly increasing worldwide. Among the constellation of weight-related comorbidities, cardiovascular disease (CVD) carries the largest burden. A large body of evidence supports the notion that endothelial dysfunction contributes to the pathogenesis of obesity-related CVD. Seminal work has revealed that oxidative stress is a key event preceding the development of endothelial dysfunction in this setting. Epigenetic connections underpinning oxidative stress and vascular dysfunction in experimental and human obesity are emerging. We and others have previously demonstrated that histone methyltransferase Set7 may participate to adverse vascular phenotypes in elevated cardiometabolic risk. Purpose To investigate whether Set7 contributes to endothelial dysfunction in a mouse model of diet-induced obesity. Methods Aortas were isolated from obese mice fed with high fat diet (HFD, 15.5% fat) for 12 weeks and control littermates fed with standard diet (STD, regular unrestricted diet). To specifically investigate Set7 role in obesity-driven endothelial dysfunction, endothelium-dependent (EDR) and independent relaxations were assessed in aortas isolated from control and obese mice, with or without endothelium-specific conditional genetic deletion of Set7. Endothelium-specific Set7 conditional knockout (mice have been generated in our facilities. Conditional Set7flox/flox mice were crossed with TekCre mice to generate E-Set7−/− mice. Set7 deletion was induced by tamoxifen. Body weight, glucose/insulin and lipid plasma levels were measured in all experimental groups. Set7 expression in endothelial cells isolated from mice aorta was assessed by RT-PCR and confocal microscopy. Reactive oxygen species (ROS) production was determined by electron spin resonance spectroscopy. Results Set7 was upregulated in endothelial cells isolated from aortas of obese WT mice as compared to lean controls. Confocal microscopy and RT-PCR of aortic tissue confirmed selective endothelial deletion of Set7 in the E-Set7−/− mice. Both WT and E-Set7−/− animals fed with HFD had similarly elevated body weight and plasma lipids (triglycerides, total and LDL cholesterol), as well as decreased HDL cholesterol. EDR to acetylcholine were impaired in aortas isolated from WT mice fed with HFD as compared to STD. Higher production of superoxide anion (O2-) was observed in aortas isolated from WT, but not in E-Set7−/−, HFD fed mice. Accordingly, apocynin and free radical scavenger TEMPOL rescued HFD-induced EDR in WT mice. Interestingly enough, E-Set7−/− HFD fed mice were protected against obesity-induced endothelial dysfunction. Conclusions Our findings demonstrate that chromatin-modifying enzyme Set7 is upregulated in obesity and involved in oxidative stress, and endothelial dysfunction. Targeting Set7 might represent a promising option to dampen oxidative stress and to prevent atherosclerotic vascular disease in this setting. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Swedish Research Council, the Swedish Heart & Lung Foundation, and King Gustav V and Queen Victoria Foundation.

Introduction Posttranslational modifications of histones play a critical role in regulating gene expression in health and disease. Activation of histone methyltransferase enhancer of zeste homolog 2 (EZH2) catalyses repressive trimethylation of histone 3 at lysine residue 27 (H3K27me3) and favours reactive oxygen species (ROS) generation as well as pro-inflammatory changes. Oxidative stress and inflammation are linked to hyperglycaemia-induced endothelial dysfunction. Purpose The present study was designed to investigate whether EZH2 may represent a novel therapeutic target against hyperglycaemia-induced abnormal phenotypes in the endothelium. Methods The effect of EZH2 was tested in aortas from male mice (3–5 months old), human aortic endothelial cells (HAECs) and aortic endothelial cells isolated from diabetic individuals (D-HAECs) in the presence and in the absence of pharmacological inhibitor GSK126 (5 μM) or gene silencing of EZH2. HAECs and aortic rings were exposed either to normal glucose (5 mM) or high glucose (25 mM) for 20 hrs. Expression levels of H3K27me3, EZH2, oxidant and pro-inflammatory genes were determined by RT-PCR, western blotting, and protein activation assay kits. Superoxide anion production was measured by electron spin resonance spectroscopy. Binding of H3K27me3 to the promoter region of candidate genes was evaluated by chromatin immunoprecipitation (ChIP). Endothelium-dependent and independent relaxations were assessed in aortic rings by organ chamber experiments. Results Immunoblotting showed a significant increase in EZH2 activity measured as H3K27me3 in HAECs exposed to high glucose and in D-HAEC. ChIP assays showed that binding of H3K27me3 to the promoter of anti-oxidant and transcription factor JunD genes triggers ROS generation and activation of inflammatory pathways. Interestingly enough, histone methyltransferase EZH2 inhibitor GSK126 or specific siRNA blunting H3K27me3 abolished hyperglycaemia-induced oxidative stress and inflammation. Moreover, targeting EZH2 rescued endothelial function. Conclusions These results uncover adverse epigenetic signatures underlying endothelial dysfunction in diabetes. Targeting EZH2 may attenuate oxidative and inflammatory transcriptional programmes and thus prevent vascular disease in this setting. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Swedish Research Council, the Swedish Heart & Lung Foundation, and King Gustav V and Queen Victoria Foundation.

Introduction There is controversy over whether SGLT2 inhibitors have efficacy in high-risk patients with heart failure (HF) and ejection fraction (EF) >60% with or without type 2 diabetes (T2D). The VERTIS CV trial studied a population of patients with T2D and atherosclerotic cardiovascular disease (ASCVD), 23% of whom had a history of HF. In VERTIS CV, ertugliflozin (ERTU) significantly reduced the risk of first and total hospitalisation for heart failure (HHF) vs placebo (PBO). Whether efficacy in the VERTIS CV population is consistent across the spectrum of pre-trial EF, particularly among those with EF >60%, is unknown. Purpose These post hoc analyses explored the effects of ERTU (5 mg; 15 mg) vs PBO on time to first and total HHF among patients in VERTIS CV across the spectrum of pre-trial EF. Methods As prospectively planned, the 2 ERTU dose groups were combined for all analyses vs PBO. Treatment effects of ERTU vs PBO on the risk of first and total HHF were analysed using adjusted Cox models for first and Andersen-Gill models for total (i.e., first + recurrent) events. Data on pre-trial EF were abstracted from the medical record at trial entry. Multiplicative interaction terms (EF × treatment arm) were used to determine if the efficacy of ERTU was modified by pre-trial EF. Results In VERTIS CV, 8246 patients were randomised to ERTU 5 or 15 mg or PBO (mean follow up 3.5 years). Overall, 5006 patients had pre-trial EF data available; 959 had EF ≤45%, 2860 had EF >45–60%, and 1187 had EF >60%. In the overall population, the event rate for first HHF was lower with ERTU vs PBO (hazard ratio [HR] 0.70; 95% CI 0.54–0.90). The findings were generally consistent across pre-trial EF (P-interaction = 0.26; Figure), including patients with pre-trial EF >60% (HR 0.72; 95% CI 0.34–1.55). In the overall population, event rate for total HHF was lower with ERTU vs PBO (HR 0.70; 95% CI 0.56–0.87). A significant interaction was observed between pre-trial EF and treatment arm for the risk of total HHF events (P-interaction = 0.02), with a greater magnitude of risk reduction in patients with a low pre-trial EF (≤45%; HR 0.39; 95% CI 0.26–0.57). However, the 95% CIs for the HR for total HHF for those with EF >45–60% and >60% nearly entirely or entirely contained the 95% CI of the overall population, respectively (Figure). Conclusion In the VERTIS CV trial of patients with T2D and ASCVD, the efficacy of ERTU in preventing first HHF was generally comparable across the spectrum of pre-trial EF. The trend for greater benefit at lower EF was statistically significant for total HHF events. Findings for patients with EF >45–60% and >60% appeared quantitively consistent with the overall findings for both first and total HHF. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): This study was sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Pfizer Inc., New York, NY, USA.

Introduction/Background* Uterine carcinosarcomas (UCSs) are aggressive biphasic malignancies, with a high grade carcinomatous/epithelial component and a high grade sarcomatous/mesenchymal counterpart. Several studies identified the carcinomatous part as the main factor affecting the aggressive behaviour of UCSs. However, other studies reported that the sarcomatous component, especially the presence of heterologous elements, was associated with a worse prognosis. The prognostic ‘driving force’ is not completely clear for these kind of tumours. For this reason, the aim of our study was to evaluate the impact of the sarcomatous component (Homologous vs Heterologous) on the overall survival (OS) and progression-free survival (PFS). Methodology This is a multicenter observational retrospective study conducted in patients with stage I and II UCSs. Result(s)* Ninety-five women with histological diagnosis of early stage UCSs were retrieved: 60 (63.2%) had tumors with homologous sarcomatous components, and 35 (36.8%) with heterologous. Tumors with a sarcomatous heterologous component were significantly larger than the homologous (T ≥ 50 mm: 82.9% vs 51.7%, p-value=0.002) and presented more often lymph-vascular space invasion (62.9% vs 25.9% respectively in patients with heterologous and homologous component, p-value=0.001). At univariate analysis, a stromal invasion ≥ 50%, the presence of clear cell, serous or undifferentiated carcinomatous component, the heterologous sarcomatous component and the FIGO stage IB and II were shown to be variables with a statistically significant negative impact on PFS. Similarly, a depth of invasion ≥ 50%, the heterologous sarcomatous component and the FIGO stage IB and II were statistically negative prognostic factors also concerning OS. At multivariate analysis, only the heterologous sarcomatous component was confirmed to be a statistically significant negative prognostic factor both on PFS (HR 2.362, 95% CI 1.207-4.623, p-value=0.012) and on OS (HR 1.950, 95% CI 1.032-3.684, p=0.040). Conclusion* In conclusion, in our large series of UCSs, both carcinomatous and sarcomatous components played a role in tumor progression and patients’ survival. However, only the sarcomatous component retained a statistical significance at the multivariable model suggesting its preeminent prognostic role in early stage UCSs.

Introduction Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce risk of hospitalisation for heart failure (HHF) in outcome trials, but the biological mediators underlying the therapeutic benefit are not well established. Purpose To identify potential biological mediators through which ertugliflozin reduces risk of HHF. Methods In VERTIS CV, 8246 patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomised to ertugliflozin 5 or 15 mg (observations pooled as prospectively planned) or placebo. Cox regression models were used to evaluate the associations between changes in 26 potential mediators with outcomes. Potential mediators were selected based on proposed mechanisms and/or differential change from baseline with SGLT2 inhibitors. Mediation criteria required 1) significant (P100%. Time-dependent models were used to evaluate associations between early (change from baseline for the first post-baseline measurement) and average (weighted average of change from baseline using all post-baseline measurements) changes in covariates with clinical outcomes. Results Over a mean of 3.5 years, the incidence rate of HHF was 0.7 and 1.1 per 100 patient-years with ertugliflozin and placebo, respectively. Among 26 candidate mediators, 9 and 13 met the mediation criteria based on early and average changes, respectively. The 3 covariates with the largest mediating effects of early changes included haematocrit (40%), haemoglobin (27%) and HDL-C (23%) (Table); other significant biomarkers included urine albumin/creatinine ratio, and serum albumin, uric acid, chloride, protein and sodium. The 3 biomarkers with the largest mediating effects in average changes included haemoglobin (63%), albumin (50%) and uric acid (47%) (Table); other significant biomarkers included haematocrit, urine albumin/creatinine ratio, body weight, serum protein and chloride, systolic blood pressure, ALT, BUN, eGFR and heart rate. Conclusions In these analyses from the VERTIS CV trial, potential markers of volume status and haemoconcentration and/or haematopoiesis were the strongest mediators of the effect of ertugliflozin on reducing risk of HHF in the early and average change periods. Other potential mediators included uric acid, lipid markers and kidney parameters. These findings provide insights into potential mechanisms through which ertugliflozin, and potentially the SGLT2 inhibitor class, may prevent HHF. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Pfizer Inc., New York, NY, USA.

Introduction/Background* Obese patients pose both surgical and anesthetic challenges, as their comorbidities contribute to adverse outcomes. In this setting, minimally invasive approach and the introduction of the Sentinel Lymph-Node (SLN) algorithm in endometrial cancer (EC) treatment acquire a particular relevance, allowing to reduce both operative times and surgical difficulties. However, conflicting data exists on the impact of Body Mass Index (BMI) on SLN detection. The primary study endpoint was to investigate the impact of obesity on overall detection rate, bilateral mapping, and mapping failure rate. In addition, we evaluated possible differences in terms of surgical management and ‘empty packet dissection’ rate among the two study groups. Methodology Multicenter, propensity-matched, retrospective study. Data of patients with apparently early-stage EC were retrospectively retrieved. Study population was divided into women with BMI Result(s)* Eight-hundred forty-four women were enrolled in the study. After a 1:1 propensity matched analysis, a total of 764 patients were identified (Group-1 n=382, Group-2 n=382). A 1.156-fold increase in the risk of mapping failure for every 5 units of increase in BMI (OR 1.156, 95% CI 1.033-1.294, p=0.012) was found, with a consequently decrease in bilateral mapping and overall detection rate (respectively OR 0.865, 95% CI 0.773-0.968, p=0.012 and OR 0.785, 95% CI 0.670-0.920, p=0.003) (figure 1). Furthermore, in the group of obese patients, in 25 cases (7.4%) the SLN dissection did not lead to the identification of lymph-node tissue at final histopathological examination (’empty packet dissection’) (Group1 vs Group 2: 3.9% vs 7.4%, p=0.046) (table 1). Conclusion* Controlling for the variables that have been proved to negatively influence the SLN detection rate, BMI was confirmed as a statistically relevant predictor of mapping failure. In addition, obese women had a significantly higher odds of empty packet dissection, which could lead to an un-intended surgical understaging.

Introduction We analysed data from the VERTIS CV trial that investigated the CV and kidney safety and efficacy of the sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin (ERTU) vs placebo (PBO) to assess the impact of metformin (MET) use at baseline (BL). These analyses are timely because the recent ESC guidelines recommendation to use SGLT2 inhibitor or GLP-1 RAs as initial glucose-lowering therapy in patients with type 2 diabetes (T2D) with or at high risk for atherosclerotic cardiovascular disease (ASCVD) has been questioned because outcome trials of these drug classes included a large proportion of patients with MET as background therapy, yet MET was not used at BL in approximately 25% of patients in each trial. Purpose These analyses determined cardiorenal endpoints of VERTIS CV according to use of BL MET to assess for evidence of treatment effect modification for ERTU by BL MET use, adjusting for the probability (propensity) of BL MET use. Methods VERTIS CV was an international, double-blind, PBO-controlled trial of 2 doses of ERTU (5 mg; 15 mg) vs PBO in patients with T2DM and ASCVD. As prospectively planned, the 2 ERTU dose groups were combined for all analyses vs PBO. Differences in risk of CV and kidney outcomes between ERTU and PBO across subgroups by BL MET use were conducted using Cox proportional hazards model along with propensity adjustment using inverse probability for treatment weighting to account for differences in patient mix between those with and without BL MET influenced by individual BL characteristics and risk factors. Treatment (categorical), BL MET use (categorical) and the interaction term between treatment and BL MET use subgroup (no or yes) were used in each model to assess effect modification by BL MET use. Hazard ratio and 95% CI are presented along with Pinteraction for evaluation of treatment effect modification by BL MET use. Results In VERTIS CV, 8246 patients were randomised to ERTU 5 mg, 15 mg or PBO. Of these, 6286 (76%) patients used MET (alone or with other glucose-lowering agents [GLA]) at BL. Differences in BL characteristics by BL MET use subgroup (no or yes) included a higher mean UACR (204.4 vs 129.8 mg/g), more patients with eGFR 0.05). Conclusions In VERTIS CV, there was no evidence for effect modification by BL MET use on the effects of ERTU on cardiorenal outcomes in patients with T2D and ASCVD. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Pfizer Inc., New York, NY, USA.

Introduction: Ovarian cancer (OC) represent nearly 4% of gynecologic malignancies and it is often diagnosed at advanced stage. Diaphragmatic surgery, a fundamental step of advanced stage ovarian cancer (ASOC) debulking surgery, is associated with a high post-operative complication incidence, which is supposedly reduced with thoracostomy tube placement. We assessed the role of intra-operative thoracostomy tube placement, as a prevention measure for post-operative complications, after diaphragmatic resection. Methods: This was a single center prospective randomized trial. Ovarian cancer patients, who underwent mono-lateral diaphragmatic resection, were randomized 1:1 into two arms. Arm A included patients receiving intra-operative thoracostomy tube placement (TP); Arm B patients did not receive thoracostomy tube placement (NTP). After surgery, all patients underwent seriate chest x-ray and ultrasound to record thoracic complications. Statistical analysis included uni- and multivariable logistic regression model (proportional odds model). Results: Three hundred seventy-one patients were screened and 88 patients were enrolled: 44 in arm A and B, respectively. No statistically significant differences for intra-operative (p = 0.291) and any grade of post-operative complication (p = 0.072) were detected, while 6.8% of patients in arm A and 22.7% in arm B experienced severe respiratory symptoms (p = 0.035); 18.2% of patients in arm A had a moderate/large pleural effusion versus 65.9% in arm B (p < 0.0001). At multivariable analysis, results confirmed that the NTP-group had a higher risk to receive post-operative thoracostomy tube placement due to pleural effusion than the TP-group (odds ratio [95% Confidence Interval] = 14.5 [3.7–57.4]). Conclusions: Thoracostomy intra-operative tube placement after diaphragmatic resection is effective to prevent post-operative thoracic complications. The extension of resection does not influence outcomes and the risk of post-operative thoracentesis or TP remain elevated.

Introduction: Vulvar cancer is a rare condition affecting older women and accounts for 3–5% of all gynecological cancers. Primary surgical treatment involves the removal of a large amount of tissue for which reconstructive surgery is often necessary with a high rate of postoperative complications. Despite several techniques for the evaluation of vulvar flap viability have been proposed, many methods cannot be performed during surgery and require expensive devices often missing in a gynecological clinic. This study aims to verify the feasibility and the safety of the vulvar flap viability evaluation through a near-infrared endoscopic probe and Indocyanine green (ICG) tracer in a small group of patients and to evaluate long-term vulvar flap outcomes.Methods: Patients with primary vulvar cancer who required surgical treatment and subsequent vulvar flap reconstructive surgery were prospectively included in the study. A 25 mg ICG vial diluted in 20 ml of saline solution was intravenously infused before closing the skin edges of the flaps. All patients were given 0.2 mg/kg body weight of intravenous ICG. After 10–15 min, a near-infrared endoscopic probe was used to evaluate the vulvar flap viability.Results: Of the 18 patients who underwent radical vulvectomy for vulvar cancer during the study period, 15 were included in the analysis. All packaged surgical flaps showed tracer uptake on the surgical margin. No intro-operative complications were recorded neither surgery-related nor to dye infusion. No surgical infection, dehiscence, or necrosis was recorded.Conclusions: Vulvar flap viability assessment using Indocyanine green and a laparoscopic infrared probe is a feasible method. All cases included in the analysis showed a dye uptake on the surgical edge of the flap. Further, prospective studies are needed to confirm the method in clinical practice and to evaluate its superiority over simple subjective clinical evaluation.

Background: Recently, it has been sustained that only surgeons skilled in minimally invasive radical hysterectomy (MI-RH) could provide valuable oncological outcomes in early-stage cervical cancer. Still, literature lacks data correlating surgeon experience with patient survival rate. We aimed to investigate the impact of surgeon training on this rate. Methods: This is a retrospective study of 243 early-stage cervical cancer treated with MI-RH. Multiple regression analyses were undertaken to investigate the impact of the surgeons learning curve, according to the number of MI-RH, on patients prognosis. Results: A steady trend of reduction in disease recurrence risk is associated with increased surgeon experience. The peak of the learning curve was shown at the 19th MI-RH (hazard ratio of disease-free survival: 0.321; 95%CI: 0.140-0.737; p= 0.007). The 3 years disease-free survival that a surgeon could provide to patients is significantly lower at the beginning of his/her learning path comparing to what he/she could guarantee once adequate experience had been achieved (75.4% and 91.6% respectively, p=0.005). Surgeon experience appears to be an independent prognostic factor. Conclusion: The experience that a surgeon can achieve practicing in MI-RH significantly influences oncological outcomes of early-stage cervical cancer patients. Future studies comparing minimally invasive and open surgery should take this into account. It would be advisable that the scientific community precisely establishes the minimum training required in the field of MI-RH for early-stage cervical cancer.

Objectives To evaluate the oncological and surgical outcome of minimally invasive radical surgery (MI-RS) compared to open radical surgery (O-RS) in locally advanced cervical cancer (LACC) after preoperative chemoradiation (CT/RT). Methods Data relative to stage IB2-IVA cervical cancer patients managed by CT/RT and RS were retrospectively analyzed. Results Starting from 686 patients, the propensity score matching resulted in 462 cases (231 per group), balanced for FIGO stage, lymph node status, histotype, tumor grade and clinical response to CT/RT. Overall, 107 recurrences were registered with no difference in the pattern of recurrences between the two surgical approaches. The 5-year disease-free survival (DFS) was 73.7% in the O-RS patients, 73.0% in the MI-RS ones (HR 1.034, 95% CI: 0.708–1.512, p=0.861). The 5-year locoregional recurrence rate was 12.5% (O-RS) versus 15.2% (MI-RS) (HR 1.174, 95% CI: 0.656–2.104, p=0.588). Deaths of disease were 62; the 5-yr disease-specific survival (DSS) was 80.4% in O-RS patients, 85.3% in the MI-RS group (HR 0.731, 95% CI: 0.438–1.220, p=0.228). Estimated blood loss was lower in the MI-RS group (p Conclusion MI-RS and O-RS are associated with similar rate of recurrence and death from disease in LACC patients managed by surgery after CT/RT. No difference in early and late complications were reported.

Purpose Chemoradiation (CT/RT) followed by radical surgery (RS) may play a role in locally advanced cervical cancer (LACC) patients with suboptimal response to CT/RT or in low-income countries with limited access to radiotherapy. Our aim is to evaluate oncological and surgical outcomes of minimally invasive radical surgery (MI-RS) compared with open radical surgery (O-RS). Patients and Methods Data for stage IB2–IVA cervical cancer patients managed by CT/RT and RS were retrospectively analyzed. Results Beginning with 686 patients, propensity score matching resulted in 462 cases (231 per group), balanced for FIGO stage, lymph node status, histotype, tumor grade, and clinical response to CT/RT. The 5-year disease-free survival (DFS) was 73.7% in the O-RS patients and 73.0% in the MI-RS patients (HR 1.034, 95% CI 0.708–1.512, p = 0.861). The 5-year locoregional recurrence rate was 12.5% (O-RS) versus 15.2% (MI-RS) (HR 1.174, 95% CI 0.656–2.104, p = 0.588). The 5-year disease-specific survival (DSS) was 80.4% in O-RS patients and 85.3% in the MI-RS group (HR 0.731, 95% CI 0.438–1.220, p = 0.228). Estimated blood loss was lower in the MI-RS group (p p p = 0.331). Fifty-six (24.2%) patients experienced late postoperative complications in the O-RS group, versus 61 patients (26.4%) in the MI-RS group (p = 0.668). Conclusion MI-RS and O-RS are associated with similar rates of recurrence and death in LACC patients managed by surgery after CT/RT. No difference in early or late complications was reported.

Introduction/Background To compare survival outcomes of laparoscopic and open surgery for radical hysterectomy (RH) among patients with early-stage cervical cancer (CC) and to identify which subgroups may benefit from one approach rather than the other. Methodology 237 and 303 consecutive patients, with clinical FIGO stage from IA1 with lymph vascular space involvement to IB1/IIA1 CC underwent open and laparoscopic RH respectively in 3 Italian Institutions. Differences in terms of progression-free survival (PFS) between the two surgical approaches were tested in the entire population and in different patient‘s subgroups. Results Median follow up was 34 months. Open and laparoscopy procedures had similar 3-yr PFS rate in the entire series (86.4% vs 85.6%, p=0.987). PFS of the two approaches were compared among subgroups stratified by tumor histology, tumor grading, tumor diameter, lymph vascular space status, parametrial invasion, lymph node status and adjuvant treatment.Open and laparoscopic approaches revealed a significantly different 3-yr PFS rate only among patients with >20 mm tumor (85.2% vs 69.2% respectively, p=0.026). On the contrary 3-yr PFS in ≤2 cm tumor did not differ between open and laparoscopic surgery (87.5% vs 93.4% respectively, p=0.151). Conclusion Tumor diameter could be considered the most important determinant to choosing to guide the choice of surgical approach in early stage CC. Women with >20 mm disease should undergo open RH. In case of tumor ≤20 mm, both of the approaches appear to be safe. Therefore, laparoscopic surgery could still be considered an option in this subgroup of patients. Disclosure Nothing to disclose.

Background Our previous study showed sub-epicardial longitudinal strain (EpiLS) was an independent prognostic factor for worse outcome in regular treated hypertension but not global longitudinal strain (GLS) and sub-endocardial longitudinal strain (EndLS). Increased blood pressure variability (BPV) has been found associated with target organ damage in hypertension. However, effects of BPV on layer-specific longitudinal strain have not been well studied. Purpose The aim of this study was to investigate the effects of different blood pressure parameters on layer-specific longitudinal strain in hypertension. Methods This study included 95 patients (57 men, age 65 ± 12 years) with uncomplicated hypertension who have been regularly treated for more than 1 year. Speckle tracking echocardiography was used for measurement of longitudinal deformation from 3 apical views of left ventricle. GLS was measured by automated function imaging (AFI). We further divided into sub-endocardial and sub-epicardial myocardium and measured their longitudinal strain by manual click-and-draw method and averaged from 3 apical views. Blood pressure parameters included office systolic blood pressure (SBP), office diastolic blood pressure (DBP), central SBP and DBP by tonometry, average 24-hour SBP and DBP, and BPV parameters by ambulatory blood pressure monitor. BPV parameters included standard deviation of daytime SBP (DSSD), standard deviation of nighttime SBP (NSSD), standard deviation of daytime DBP (DDSD), and standard deviation of nighttime DBP (NDSD). Results We divided subjects into low and high group according to median level of each strain. No blood pressure parameters were different between low and high EndLS group except week difference in NDSD (9.0 ± 3.4 vs. 7.8 ± 2.0 mmHg, p = 0.051). NSSD (11.2 ± 4.6 vs. 9.3 ± 2.9 mmHg, p = 0.027) and NDSD (9.1 ± 3.4 vs. 7.7 ± 2.0 mmHg, p = 0.031) were significant increased in low GLS group but not other parameters. DDSD (10.3 ± 3.0 vs. 9.0 ± 2.5 mmHg, p = 0.034), NSSD (11.4 ± 4.4 vs. 9.1 ± 3.1 mmHg, p = 0.006), and NDSD (9.2 ± 3.2 vs. 7.6 ± 2.2 mmHg, p = 0.012) were significantly increased in low EpiLS group. Conclusions Only BPV parameters were associated with decreased longitudinal strain in hypertension. Effects of BPV were majorly noted in EpiLS.

A hysterectomy for enlarged uteri is considered a challenge for gynaecologic surgeons, due to the limit of exposure to surgical spaces. Our objective is to investigate the different variables that may have an impact on the risk of conversion to open surgery. This is a retrospective cohort study consisting of 133 women who were submitted to surgery for uterine fibroids and who underwent total hysterectomy by laparoscopic approach attempt. The median uterus weight was 622 grams (range 301–3882) and the median maximum diameter of the bigger fibroid was 74 mm (range 33–148). We registered 13 (9.8%) cases of conversion to laparotomy. Minor and major post-operative complications were recorded in 4 (3%) and in 4 (3%) cases, respectively. After multivariable analysis, the surgeon’s experience (OR: 0.24; 95% CI: 0.06–0.94, p =.027) and a maximum diameter of the biggest fibroid ≥10 cm (4.7; 1.39–15.87; p =.046), but not the uterus weight were associated with the risk of conversion to open surgery.IMPACT STATEMENTWhat is already known on this subject? Laparoscopic procedures for enlarged uteri are well described in literature; however, the only parameters that have been studied for the success of a laparoscopic procedure have been the uterus weight and the surgeon’s experience. What do the results of this study add? This study aimed to value all the possible variables related to the successful of laparoscopic procedures; in fact, we investigated not only the uterine weight, but in our multivariate analysis, the position of the fibroids, the trocar’s setting, etc. were analysed. What are the implications of these findings for clinical practice and/or further research? This study reported novel data about the feasibility of laparoscopic hysterectomy for enlarged uteri. In opposition to the literature, the uterine weight is not a predictive value for laparotomic conversion. Moreover, we discussed the possible reasons of our novel findings. It opens new perspective to create a predictive value of laparoscopic feasibility for the different types of enlarged uteri.

PurposeWe review augmented (AR) and virtual reality (VR) applications in radiotherapy as found in the scientific literature and highlight future developments enabled by the use of small mass-produced devices and portability of techniques developed in other fields to radiotherapy.AnalysisThe application of AR and VR within radiotherapy is still in its infancy, with the notable exception of training and teaching applications. The relatively high cost of equipment needed to generate a realistic 3D effect seems one factor that has slowed down its use, but also the sheer amount of image data is relatively recent, were radiotherapy professionals are only beginning to explore how to use this to its full potential. This increased availability of 3D data in radiotherapy will drive the application of AR and VR in radiotherapy to efficiently recognise and extract key features in the data to act on in clinical decision making.ConclusionThe development of small mass-produced tablet devices coming on the market will allow the user to interact with computer-generated information more easily, facilitating the application of AR and VR. The increased connectivity enabling virtual presence of remote multidisciplinary team meetings heralds significant changes to how radiotherapy professionals will work, to the benefit of our patients.

Objective Currently, the best method for CRC screening is colonoscopy, which ideally (where possible) is performed under partial or deep sedation. This study aims to evaluate the efficacy of the Endotics System, a new robotic device composed of a workstation and a disposable probe, in performing accurate and well-tolerated colonoscopies. This new system could also be considered a precursor of other innovating vectors for atraumatic locomotion through natural orifices such as the bowel. The flexible probe adapts its shape to the complex contours of the colon, thereby exerting low strenuous forces during its movement. These novel characteristics allow for a painless and safe colonoscopy, thus eliminating all major associated risks such as infection, cardiopulmonary complications and colon perforation. Methods An experimental study was devised to investigate stress pattern differences between traditional and robotic colonoscopy, in which 40 enrolled patients underwent both robotic and standard colonoscopy within the same day. Results The stress pattern related to robotic colonoscopy was 90% lower than that of standard colonoscopy. Additionally, the robotic colonoscopy demonstrated a higher diagnostic accuracy, since, due to the lower insufflation rate, it was able to visualize small polyps and angiodysplasias not seen during the standard colonoscopy. All patients rated the robotic colonoscopy as virtually painless com-pared to the standard colonoscopy, ranking pain and discomfort as 0.9 and 1.1 respectively, on a scale of 0 to 10, versus 6.9 and 6.8 respectively for the standard device. Conclusions The new Endotics System demonstrates efficacy in the diagnosis of colonic pathologies using a procedure nearly completely devoid of pain. Therefore, this system can also be looked upon as the first step toward developing and implementing colonoscopy with atraumatic locomotion through the bowel while maintaining a high level of diagnostic accuracy.

The biocompatibility of dental implants coated with titania/hydroxyapatite (HA) and titania/bioactive glass (BG) composites obtained via sol-gel process was investigated using an in vitro and in vivo model. A device for the in vitro testing of screw-shaped dental implants was developed, in order to well compare the two experimental models studying the behavior of human MG63 osteoblast-like cells seeded onto a particular geometry. The expression of some biochemical parameters of osteoblastic phenotype (alkaline phosphatase specific activity, collagen and osteocalcin production) and some indications on cells morphology obtained by scanning electron microscopy were evaluated. The in vitro and in vivo models were compared after implants insertion in rabbit tibia and femur. The removal torque and histomorphometric parameters (percentage of bone in contact with implant surface and the amount of bone inside the threaded area) were examined. A good agreement was found between the in vitro and in vivo models. These experiments showed better performances of HA and BG sol-gel coated dental implants with respect to uncoated titanium; in particular, it was found that in vitro the HA coating stimulates osteoblastic cells in producing higher level of ALP and collagen, whereas in vivo this surface modification resulted in a higher removal torque and a larger bone-implant contact area. This behavior could be ascribed to the morphology and the chemical composition of the implants with rough and bioactive surfaces.

The biocompatibility of titania/hydroxyapatite (TiO2HA) composite coatings, at different ratio obtained by sol–gel process, was investigated studying the behavior of primary cultures of rat osteoblastic cells, isolated by femoral trabecular bone tissue. Moreover, the results have been compared with the response of human osteoblast-like MG63 cell line. Cytotoxicity of coatings was assessed by lactate dehydrogenase activity (LDH). The cellular behavior was analyzed by the cell proliferation (MTT test), cell morphology (SEM) and the biochemical markers evaluation of osteoblastic phenotype, such as alkaline phosphatase activity (ALP) and osteocalcin production. The results showed that TiO2/HA coatings have no toxic effects and seemed to be a good support for cell adhesion and proliferation. Moreover, these materials allowed the differentiation of osteoblasts, stimulating the expression of alkaline phosphatase activity. The responses of the primary rat osteoblasts and human osteoblast-like MG63 cell line grown onto these coatings were similar in terms of proliferation and ALP activity. Differences were found considering the osteocalcin production. The results show that these coatings, thanks to their chemical composition and the deposition technique, are very promising for the potential orthopedic and dental applications.

Lacidipine, a third generation dihydropyridine calcium antagonist, has demonstrated pronounced anti-atherosclerotic activity in preclinical studies. The drug can act at several stages within the atherosclerotic process, utilising its antihypertensive and antioxidant properties to protect hypertensive animals against mortality and vascular damage, to reduce cholesterol levels from the vessel wall of hypercholesterolaemic animals, and to reduce the progression of existing atherosclerotic lesions. The clinical benefit of lacidipine in atherosclerosis has recently been confirmed in humans in a large, multicentre, comparative, 4-year clinical trial involving patients with mild to moderate hypertension. The European Lacidipine Study on Atherosclerosis (ELSA) showed that lacidipine was able to slow the progression of atherosclerosis, measured as carotid intimato-media thickness, by 40% compared with atenolol (p = 0.0073). Although further comparative trials are needed, based on the results of ELSA, lacidipine is likely to become a promising therapeutic agent for atherosclerosis.

The biocompatibility of titania/hydroxyapatite (TiO /HA) composite coatings, at di!erent ratio obtained by sol}gel process, were investigated studying the behaviour of human MG63 osteoblast-like cells. The biocompatibility was evaluated by means of cytotoxicity and cytocompatibility tests. Cytotoxicity tests, i.e., neutral red (NR), MTT and kenacid blue (KB) assays, were performed to assess the in#uence of the material extracts on lysosomes, mitochondria and cell proliferation, respectively. Cell proliferation, some preliminary indications of cell morphology, alkaline phosphatase activity, collagen and osteocalcin production of MG63 cells, cultured directly onto TiO /HA substrates, were evaluated. The results showed that these materials have no toxic e!ects. Cell growth and morphology were similar on all the materials tested; on the contrary, alkaline-phosphatase-speci"c activity and collagen production of osteoblasts cultured on TiO /HA coatings were signi"cantly higher than uncoated titanium and polystyrene of culture plate and were in#uenced by chemical composition of the coatings. In particular, TiO /HA coating at 1:1 ratio (w/w) seems to stimulate more than others the expression of some di!erentiation markers of osteoblastic phenotype. TiO /HA coatings resulted to be bioactive owing to the presence of hydroxyl groups detected on their surface that promote the calcium and phosphate precipitation and improve the interactions with osteoblastic cells. 2001 Elsevier Science Ltd. All rights reserved.

In Italy the transport of goods is done mainly by road and is complicated matter. Companies engaged in the passenger transport are state-controlled companies and little companies of taxi service. The work of the driver in public or private companies carrying people or goods shows a lot of similarities and remains one of the most difficult job. The analyzed job-risks are: vibration, noise, manual handling of loads by workers involved in loading /unloading the vehicle, exposure to chemical pollutants and the indoor environment of the cabin stress. The protocol for health surveillance should therefore be drawn up taking into account: current legislation, risk factors, most frequently occurring diseases and/or disease that may affect job that may affect job performance.

In order to assess the relationship between impaired reaction times and other clinical parameters a study was conducted on a population of public transport drivers, 26 impaired reaction times subjects and 114 controls, matched for age, sex and type of job-task, compared for years of employment, blood pressure, audiometric test, mood disorders, sleepiness and body mass index (BMI). Statistical analysis indicates a close trend to relationship of reaction times impairment with BMI and hypertension; these two variables are also correlated. Our results agree with previous literature: despite the fact that mechanisms underlying the relationship between BMI and cognitive impairments remains unknown, subclinical levels of pathophysiologic changes associated with elevated BMI, could account for the observed differences in our samples. Assessing eligibility in occupational medicine, it could be suitable to evaluate some preventive measures evaluating the efficacy of weight loss on cognitive function and on the ability to work safely.

Back pain is a very common disease among the drivers. The project, based on the assumptions of the Neurocognitive Rehabilitation theory, we propose the prevention of musculoskeletal diseases and the improvement of the health of the subjects, using multiple levels of intervention. In addition to the more traditional prevention interventions it provides theoretical and practical training and education to the perception of the rachis inside job performance, through laboratories and individual treatment as secondary prevention and to facilitate the work. The comparison of three compilations of a questionnaire survey on the perception of the body and the sitting position, given before the course, at its conclusion and at a later time, shows significant change in the subjects' responses, which suggests that the course has changed way of thinking and organizing body and sitting position. Subsequent clinical-epidemiological surveys could test the hypothesis that this has effects of primary and secondary prevention.

A Questionnaire on sleep and vigilance disorders has been developed by the Italian Association of Sleep Medicine to help the occupational health physicians in screening for sleep disorders. Aim of this study was to compare the Questionnaire with standardized questionnaires for sleepiness and sleep apnea and with a polysomnographic evaluation. Four hundred sixty-three (463#) commercial bus drivers (454M, 9F; mean age +/- S.D. 41.6 +/- 8.1 yrs; mean body mass index 26.2 +/- 3.6 kg/m2) underwent clinical evaluation that included the Italian Association of Sleep Medicine Questionnaire on sleep and vigilance disorders and two standardized questionnaires (Berlin Questionnaire and Epworth Sleepiness Scale). According to the Italian Association of Sleep Medicine Questionnaire on sleep and vigilance disorders 40 subjects presented an high risk for sleep disturbance and in 28 subject the questionnaires were concordant. Preliminary results (16 patients) showed an high rate of concordance between questionnaire and PSG. These data strongly suggest that sleep disorders and symptoms, that are frequent in a population of professional bus drivers, should be better evaluated during occupational health visit.

In the present work a titania network encapsulating a hydroxyapatite particulate phase is proposed as a bioceramic composite coating. The coating on a titanium substrate was produced starting from a sol containing a mixture of titania colloidal particles and hydroxyapatite submicron particles using the dip-coating technique. The microstructure, the morphology and the surface chemical composition of the coating were characterised using X-ray diffraction (XRD), scanning electron microscopy (SEM) and X-ray photoelectron spectroscopy (XPS), respectively. Adhesion tests were also performed. These analyses showed that the obtained coating was chemically clean, homogeneous, rough, porous, with a low thickness and well-defined phase composition as well as a good adhesion to the substrate. Copyright © 2001 Elsevier Science Ltd.

Experiments were designed to determine the effect of oxygen-derived free radicals in isolated canine basilar arteries. Rings with and without endothelium were suspended for isometric tension recording in modified Krebs-Ringer bicarbonate solution bubbled with 95% O2-5% CO2 (temperature = 37 degrees C; pH = 7.4). A radioimmunoassay technique was used to measure production of prostaglandins and thromboxane B2. Xanthine oxidase (1-9 mU/ml, in the presence of 10(-4) M xanthine) and hydrogen peroxide (10(-6) to 10(-4) M) caused concentration-dependent contractions. The removal of endothelium reversed these contractions into relaxations. Contractions to xanthine oxidase and hydrogen peroxide were inhibited in the presence of superoxide dismutase (150 U/ml), catalase (1,200 U/ml), indomethacin (10(-5) M), and SQ 29548 (10(-6) M) but not in the presence of deferoxamine (10(-4) to 10(-3) M) and dimethyl sulfoxide (10(-4) M). NG-monomethyl-L-arginine (3 x 10(-5) M) augmented the contractions to hydrogen peroxide. Xanthine oxidase stimulated production of 6-ketoprostaglandin F1 alpha, prostaglandin F2 alpha, prostaglandin E2, and thromboxane B2. The stimulatory effect was prevented by the removal of endothelial cells. These studies suggest that xanthine oxidase causes endothelium-dependent contractions mediated by: 1) hydrogen peroxide-induced stimulation of the endothelial metabolism of arachidonic acid via the cyclooxygenase pathway, leading to activation of prostaglandin H2-thromboxane A2 receptors, and 2) inactivation of basal production of nitric oxide by superoxide anions.

Electrocardiographic (ECG) alterations in the course of sub-arachnoid hemorrhage (SAH) have frequently been reported. The most frequent anomalies reported were lengthening of the QT interval, very negative or positive deep T waves, elevation or depression of the ST segment and the presence of U waves. We report 70 cases of SAH secondary to rupture of intracranial aneurysm (part of a larger group of 150) with ECG changes. We review the literature with particular regard to discussion of the possible pathogenesis of ECG changes and to the way they may affect the general clinical course.

For several years the literature has reported a high prevalence of upper limb musculoskeletal disorders among medical staff carrying out digestive endoscopy.The EPM research unit, in cooperation with the Italian Society of Digestive Endoscopy (SIED) and with the patronage of the Italian Society of Ergonomics (SIE), undertook research that would permit assessment of upper limb biomechanical overload using the OCRA method during gastroscopy and colonoscopy and, via a pilot study, collect health data on 179 workers employed in endoscopy services.Risk analysis showed slight exposure levels for the arm bearing the instrument and a medium-to-high exposure for the other arm. However, the study of diseases in this sample showed a higher prevalence than in the reference population not exposed to risk for the upper limbs and in particular in the hand-wrist area.Risk analysis highlighted possible ergonomic measures that would be easy to implement and which would significantly reduce the risk.

Controlled trials of sclerotherapy for the prevention of the first variceal hemorrhage in cirrhotics have given conflicting results. In the present study, 106 cirrhotics were randomized to sclerotherapy (55 patients) or control group (51 patients). Admission criteria were no history of previous variceal bleeding and the presence of high-risk varices, i.e., a variceal score less than or equal to 0 according to Beppu et al. Sclerotherapy sessions were performed at time zero, 7 days, 30 days, and then monthly until eradication. Follow-up endoscopies were performed at 6-month intervals thereafter. Control patients underwent repeat endoscopy at 6-month intervals. Bleeding episodes were treated by sclerotherapy in both groups, whenever possible. Mean follow-up was 24 months. Analysis of the results was performed by the intention-to-treat method. Variceal bleeding occurred in 19 sclerotherapy patients (34.5%) and in 17 controls (35.4%, P = NS). Overall mortality was 34.5% in sclerotherapy patients and 50% in controls (P = NS). Seven of the 19 sclerotherapy patients (36.8%) and 11 of the 17 controls (64.7%) who bled died of hemorrhage (P less than 0.05, log-linear model). It is concluded that prophylactic sclerotherapy does not reduce the incidence of first variceal bleeding in cirrhotics. However, there seems to be a trend toward a lower bleeding-related mortality in sclerotherapy patients than in controls.

The percentage of bladder cancer as occupational disease in West-Europe is of 5/10%, but only a few amount of them are recognized as occupational disease from INAIL. The above mentioned research project is realized in order to decrease the gap between expected and claimed cases of occupational disease and it is conducted with the collaboration of ASL of Pisa, ASL of Empoli, Azienda Ospedaliera Universitaria Pisana and INAIL. 677 patients with bladder cancer were interviewed by phone, among them 64 subjects had a working experience compatible with neoplastic risks because had a previous occupational exposure to aromatic amines and metal working fluids. These cases were discussed into a Medical Staff and 40 cases were considered "probable" for occupational disease, 18 "possible", 3 cases are suspended for more research, 3 cases are considered "no professional disease". The research allows finding out a great number of bladder cancer, increasing the total amount of workers with occupational disease. The integrated approach with the collaboration among different institutions is surely the best way to allow and guarantee a suitable and right protection of workers with occupational disease.

In 1984 we started a prospective controlled trial comparing endoscopic sclerotherapy (ES) with the distal splenorenal shunt (DSRS) in the elective treatment of variceal hemorrhage in cirrhotic patients. The study population included 40 patients with cirrhosis and portal hypertension referred to our department from October 1984 to March 1988. These patients were drawn from a pool of 173 patients who underwent either elective surgery or endoscopic sclerotherapy during this time. Patients were assigned to one of the two groups according to a random-number table: 20 to DSRS and 20 to ES. During the postoperative period, no DSRS patient died, while one ES patient died of uncontrolled hemorrhage. One DSRS patient had mild recurrent variceal hemorrhage despite an angiographically patent DSRS. Four ES patients suffered at least one episode of gastrointestinal bleeding: two from varices and two from esophageal ulcerations. Five ES patients developed transitory dysphagia. Long-term follow-up was complete in all patients. Two-year survival rates for shunt (95%) and ES (90%) groups were similar. One DSRS patient rebled from duodenal ulcer, while three ES patients had recurrent bleeding from esophagogastric sources (two from varices and one from hypertensive gastropathy). One DSRS and two ES patients have evolved a mild chronic encephalopathy; four DSRS and two ES patients suffered at least one episode of acute encephalopathy. Two ES patients had esophageal stenoses, which were successfully dilated. Preliminary data from this trial seem to indicate that DSRS, in a subgroup of patients with good liver function and a correct portal-azygos disconnection, more effectively prevents variceal rebleeding than ES. However no significant difference in the survival of the two treatment groups was noted.

Background Endoscopic ultrasonography, both conventional and interventional, has been used increasingly during the past 20 years and is deemed a safe technique. Its complication rate, however, has been studied to only a limited extent. This multicentre investigation sought to establish the complication rate for a large number of endoscopic ultrasonography procedures. Methods By means of a questionnaire, we collected data from six centres on the number of endoscopic ultrasonography examinations performed and divided them into conventional and interventional examinations of the upper and lower gastrointestinal tract. Information was obtained on technical modalities such as instruments and sedation and, for interventional endoscopic ultrasonography, indications, pre-procedural exams and technical details (needle calibre, number of passes) had to be specified. Complications were classified as mild, moderate, severe or fatal and their onset as immediate, early or late. Variables that entered into the analysis of complication rate included type of endoscopic ultrasonography instrument used, type and site of lesion biopsied, number of needle passes and operator experience. Results Eleven thousand five hundred thirty nine endoscopic ultrasonographic procedures were reported, of which 10,731 were conventional and 808 interventional. No deaths occurred; there were 14 (0.12%) complications, 5 (0.046%) of them following conventional endoscopic ultrasonography and 9 (1.11%) after interventional endoscopic ultrasonography. Seven complications were mild, four moderate and three severe. Conclusions Both conventional and interventional endoscopic ultrasonography were confirmed to be acceptably safe techniques.