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1.
World J Urol ; 41(10): 2591-2597, 2023 Oct.
Article in English | MEDLINE | ID: mdl-35639159

ABSTRACT

PURPOSE: Different energy sources are employed to perform en-bloc transurethral resection of bladder tumor (ERBT). No study compared different energy sources in ERBT. The aim is to compare the different ERBT sources in terms of pathological, surgical and postoperative outcomes. METHODS: This is a sub-analysis of a prospective randomized trial enrolling patients submitted to ERBT vs conventional TURBT from 03/2018 to 06/2021 (NCT04712201). 180 patients enrolled in ERBT group were randomized 1:1:1 to receive monopolar (m-ERBT), bipolar (b-ERBT) or thulium laser (l-ERBT). Endpoints were the comparison between energies in term of pathological analysis, intra, and post-operative outcomes. RESULTS: 49 (35%) m-ERBT, 45 (32.1%) b-ERBT, and 46 (32.9%) l-ERBT were included in final analysis. The rate of detrusor muscle (DM) presence was comparable between the energies used (p = 0.796) or the location of the lesion (p = 0.662). Five (10.2%), 10 (22.2%) and 0 cases of obturator nerve reflex (ONR) were recorded in m-ERBT, b-ERBT and I-ERBT groups, respectively (p = 0.001). Conversion to conventional TURBT was higher for lesions located in the anterior wall/dome/neck (p < 0.001), irrespective from the energy used. The presence of artifact in the pathological specimen was higher for lesions at the posterior wall (p = 0.03) and trigone (p = 0.03). CONCLUSIONS: In our study, no difference in staging feasibility among energies was found. Laser energy might be beneficial in lateral wall lesions to avoid ONR. Since there is an increased risk of ERBT conversion to conventional TURBT for lesions of the anterior wall, electrocautery might be preferred over laser to avoid waste of material.


Subject(s)
Urinary Bladder Neoplasms , Humans , Prospective Studies , Urinary Bladder Neoplasms/surgery , Urinary Bladder Neoplasms/pathology , Cystectomy , Muscles , Thulium
2.
World J Urol ; 41(10): 2583-2589, 2023 Oct.
Article in English | MEDLINE | ID: mdl-35665840

ABSTRACT

PURPOSE: Bladder perforation (BP) is the most important intraoperative adverse event of transurethral resection of bladder tumor (TURBT). It is frequently underreported despite its impact on the postoperative course. There is no standardized classification of BP. The study aims to develop a classification of the depth of endoscopic bladder perforation during TURBT. METHODS: This is a sub-analysis of a prospective randomized trial enrolling 248 patients submitted to en-bloc vs conventional TURBT from 03/2018 to 06/2021. The DEpth of Endoscopic Perforation (DEEP) scale is as follows: "0" visible muscular layer with no perivesical fat; "1" visible muscle fibers with spotted perivesical fat; "2" exposition of perivesical fat; "3" intraperitoneal perforation. Logistic and linear regression models were used to investigate predictors of high-grade perforations (DEEP 2-3) and to assess whether the DEEP scale independently predicted patients' postoperative outcomes. RESULTS: A total of 146/248 (58.9%), 56/248 (22.6%), 41/248 (16.5%), 5/248 (2.0%) patients presented DEEP grade 0, 1, 2, and 3, respectively. Female gender [B coeff. 0.255 (95% CI 0.001-0.513); p = 0.05], tumor location [B coeff. 0.188 (0.026-0.339); p = 0.015], and obturator-nerve reflex [B coeff. 0.503 (0.148-0.857); p = 0.006] were independent predictors of DEEP. The scale predicted independently major complications [Odd Ratio (OR) 2.221 (1.098-4.495); p = 0.026], no post-operative chemotherapy intravesical instillation [OR 9.387 (2.434-36.200); p = 0.001], longer irrigation time [B coeff. 0.299 (0.166-0.441); p < 0.001] and hospital stay [B coeff. 0.315 (0.111-0.519); p = 0.003]. CONCLUSION: The DEEP scale provides a visual tool for grading bladder perforation during TURBT, which can help physicians standardize complication reporting and plan postoperative management accordingly.


Subject(s)
Transurethral Resection of Bladder , Urinary Bladder Neoplasms , Humans , Female , Prospective Studies , Urinary Bladder Neoplasms/pathology , Urologic Surgical Procedures/adverse effects , Urinary Bladder/surgery , Urinary Bladder/pathology
3.
Neoplasma ; 70(3): 458-467, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37498071

ABSTRACT

We retrospectively compared long-term biochemical recurrence rates (BCR) in pN1 PCa patients that underwent adjuvant radiotherapy (aRT) vs. no aRT/early salvage (esRT) after robot-assisted radical prostatectomy and extended pelvic lymphadenectomy. All PCa pN1 M0 patients treated at a single high-volume center between 2010 and 2020 were analyzed. Patients with <10 LNs yield, or >10 positive LNs, or persistently detectable PSA after RARP were excluded. Kaplan-Meier (KM) plots depicted BCR rates. Multivariable Cox regression models (MCRMs) focused on predictors of BCR. The cumulative incidence plot depicted BCR rates after propensity score (PS) matching (ratio 1:1). 220 pN1 patients were enrolled, 133 (60.4%) treated with aRT and 87 (39.6%) with no-aRT/esRT. aRT patients were older, with higher rates of postoperative ISUP grade group 4-5, and higher rates of pT3b stage. The actuarial BCR was similar (aRT 39.8% vs. no-aRT/esRT 40.2%; p=1). Median time to BCR was 62 vs. 38 months in aRT vs. no-aRT/esRT patients (p=0.001). In MCRMs, patients managed with no-aRT/esRT were associated with higher rates of BCR over time (hazard ratio [HR]: 3.27, p<0.001). ISUP grade group 5 (HR: 2.18, p<0.01) was an independent predictor of BCR. In PS-matched cumulative incidence plots, the BCR rate was significantly higher in the aRT group (76.4 vs. 40.4%; p<0.01). Patients managed with no-aRT/esRT experienced BCR approximately two years before the aRT group. Despite, the important BCR benefit after aRT, this treatment strategy is underused in daily practice.


Subject(s)
Prostate-Specific Antigen , Prostatic Neoplasms , Male , Humans , Prostatic Neoplasms/radiotherapy , Prostatic Neoplasms/surgery , Retrospective Studies , Salvage Therapy/adverse effects , Radiotherapy, Adjuvant , Prostatectomy/adverse effects , Neoplasm Recurrence, Local/surgery
4.
Int J Urol ; 30(1): 63-69, 2023 01.
Article in English | MEDLINE | ID: mdl-36349904

ABSTRACT

OBJECTIVES: Technical limitations of ureteroscopic (URS) biopsy has been considered responsible for substantial upgrading rate in upper tract urothelial carcinoma (UTUC). However, the impact of tumor specific factors for upgrading remain uninvestigated. METHODS: Patients who underwent URS biopsy were included between 2005 and 2020 at 13 institutions. We assessed the prognostic impact of upgrading (low-grade on URS biopsy) versus same grade (high-grade on URS biopsy) for high-grade UTUC tumors on radical nephroureterectomy (RNU) specimens. RESULTS: This study included 371 patients, of whom 112 (30%) and 259 (70%) were biopsy-based low- and high-grade tumors, respectively. Median follow-up was 27.3 months. Patients with high-grade biopsy were more likely to harbor unfavorable pathologic features, such as lymphovascular invasion (p < 0.001) and positive lymph nodes (LNs; p < 0.001). On multivariable analyses adjusting for the established risk factors, high-grade biopsy was significantly associated with worse overall (hazard ratio [HR] 1.74; 95% confidence interval [CI], 1.10-2.75; p = 0.018), cancer-specific (HR 1.94; 95% CI, 1.07-3.52; p = 0.03), and recurrence-free survival (HR 1.80; 95% CI, 1.13-2.87; p = 0.013). In subgroup analyses of patients with pT2-T4 and/or positive LN, its significant association retained. Furthermore, high-grade biopsy in clinically non-muscle invasive disease significantly predicted upstaging to final pathologically advanced disease (≥pT2) compared to low-grade biopsy. CONCLUSIONS: High tumor grade on URS biopsy is associated with features of biologically and clinically aggressive UTUC tumors. URS low-grade UTUC that becomes upgraded to high-grade might carry a better prognosis than high-grade UTUC on URS. Tumor specific factors are likely to be responsible for upgrading to high-grade on RNU.


Subject(s)
Carcinoma, Transitional Cell , Ureteral Neoplasms , Urinary Bladder Neoplasms , Humans , Nephroureterectomy , Carcinoma, Transitional Cell/pathology , Urinary Bladder Neoplasms/surgery , Prognosis , Ureteroscopy , Ureteral Neoplasms/surgery , Ureteral Neoplasms/pathology , Biopsy , Retrospective Studies
5.
J Urol ; 208(3): 570-579, 2022 09.
Article in English | MEDLINE | ID: mdl-35549312

ABSTRACT

PURPOSE: The correct risk categorization and staging of upper tract urothelial cancer (UTUC) is key for disease management. Computerized tomography urography and urinary cytology have limited accuracy for risk stratification of UTUC. Ureteroscopy may increase the risk of bladder cancer recurrence. Recently, Bladder EpiCheckTM (EpiCheck) showed a high accuracy in the detection of bladder cancer. The aim of the study is to investigate the diagnostic accuracy of EpiCheck in the clinical management of UTUC and to compare it with urinary cytology. MATERIALS AND METHODS: In this single-arm, blinded, prospective, single-center study (February 2019-December 2020), all patients who were candidates for ureteroscopy for suspicion of UTUC were included. Bladder and upper urinary tract (UUT) samples were collected before ureteroscopy to test for cytology and Epicheck. EpiCheck accuracy was calculated in bladder and UUT samples and compared to cytology. RESULTS: EpiCheck resulted diagnostic in 83/86 (97%) and 73/75 (97%) of UUT and bladder samples. Histology was positive in 47/83 (57%) and 42/73 (58%) cases, respectively. In UUT samples, EpiCheck yielded a sensitivity/specificity/ negative predictive value (NPV)/positive predictive value of 83%/79%/77%/84% vs 59%/88%/61%/87% of cytology. The sensitivity/NPV for high-grade tumors was 96%/97% for EpiCheck vs 71%/86% for cytology. EpiCheck indicated ureteroscopy in 45/80 (56%) patients, missing 17%/4% of all/high-grade UTUC with 9% of unnecessary ureteroscopy. In bladder samples, the sensitivity/NPV for high-grade tumors was 71%/88% for EpiCheck and 59%/87% for cytology. CONCLUSIONS: Epicheck may be an important tool to decrease the number of unnecessary ureteroscopy. The clinical implementation of EpiCheck in UTUC warrants further investigation in multicentric prospective randomized trials.


Subject(s)
Carcinoma, Transitional Cell , Urinary Bladder Neoplasms , Biomarkers, Tumor/genetics , Carcinoma, Transitional Cell/pathology , DNA Methylation , Humans , Neoplasm Recurrence, Local/genetics , Prospective Studies , Urinary Bladder Neoplasms/pathology
6.
BJU Int ; 129(4): 524-533, 2022 04.
Article in English | MEDLINE | ID: mdl-34687137

ABSTRACT

OBJECTIVES: To assess upgrading rates in patients on active surveillance (AS) for prostate cancer (PCa) after serial multiparametric magnetic resonance imaging (mpMRI). METHODS: We conducted a retrospective analysis of 558 patients. Five different criteria for mpMRI progression were used: 1) a Prostate Imaging Reporting and Data System (PI-RADS) score increase; 2) a lesion size increase; 3) an extraprostatic extension score increase; 4) overall mpMRI progression; and 5) the number of criteria met for mpMRI progression (0 vs 1 vs 2-3). In addition, two definitions of PCa upgrading were evaluated: 1) International Society of Urological Pathology Grade Group (ISUP GG) ≥2 with >10% of pattern 4 and 2) ISUP GG ≥ 3. Estimated annual percent changes methodology was used to show the temporal trends of mpMRI progression criteria. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of mpMRI progression criteria were also analysed. Multivariable logistic regression models tested PCa upgrading rates. RESULTS: Lower rates over time for all mpMRI progression criteria were observed. The NPV of serial mpMRI scans ranged from 90.5% to 93.5% (ISUP GG≥2 with >10% of pattern 4 PCa upgrading) and from 98% to 99% (ISUP GG≥3 PCa upgrading), depending on the criteria used for mpMRI progression. A prostate-specific antigen density (PSAD) threshold of 0.15 ng/mL/mL was used to substratify those patients who would be able to skip a prostate biopsy. In multivariable logistic regression models assessing PCa upgrading rates, all five mpMRI progression criteria achieved independent predictor status. CONCLUSION: During AS, approximately 27% of patients experience mpMRI progression at first repeat MRI. However, the rates of mpMRI progression decrease over time at subsequent mpMRI scans. Patients with stable mpMRI findings and with PSAD < 0.15 ng/mL/mL could safely skip surveillance biopsies. Conversely, patients who experience mpMRI progression should undergo a prostate biopsy.


Subject(s)
Prostate , Prostatic Neoplasms , Humans , Image-Guided Biopsy/methods , Magnetic Resonance Imaging/methods , Male , Neoplasm Grading , Prostate/diagnostic imaging , Prostate/pathology , Prostatic Neoplasms/diagnostic imaging , Prostatic Neoplasms/pathology , Retrospective Studies , Watchful Waiting
7.
J Urol ; 205(2): 392-399, 2021 02.
Article in English | MEDLINE | ID: mdl-32935620

ABSTRACT

PURPOSE: We report the reliability of computerized tomography urography and ureteroscopy in the diagnosis and management of upper tract urothelial carcinoma. MATERIALS AND METHODS: From 2015 to November 2018 we prospectively collected and retrospectively analyzed 244 cases of ureteroscopy with available preoperative computerized tomography urography. Computerized tomography urography was categorized as positive, suspicious, unlikely and negative. Correspondence between imaging, ureteroscopy and histology was analyzed. The therapeutic indication, based on 2020 EAU Guidelines and patient clinical data, was recorded before and after ureteroscopy. Cohen's Kappa was used for agreement analysis. Logistic regression was used for prediction of positive ureteroscopy. RESULTS: Ureteroscopy was positive for upper tract urothelial carcinoma in 107/115 (93%), 48/77 (62.3%), 15/27 (55.6%) and 12/25 (48%) cases with positive, suspicious, unlikely and negative computerized tomography urography, respectively. On cytohistology the result was confirmed in 164/182 (90.1%) cases. The positive predictive value of a filling defect, stenosis, thickening and hydronephrosis on computerized tomography urography was 87.7% (121/138 cases), 65.6% (21/32), 69.6% (64/92) and 79.7% (59/74), respectively. On multivariate analysis a filling defect (95% CI 2.76-11.5, OR 5.63, p <0.0001) or hydronephrosis (1.04-6.18, OR 2.52, p=0.04) was associated with ureteroscopy outcome. Among cases with positive computerized tomography urography and ureteroscopy, the lesions differed in dimensions (20/107), number (14/107) and site (11/107), for a total of 45/107 (42.1%) cases. The indication of elective treatment changed after ureteroscopy in 37/76 (48.1%) cases (Kappa=0.31), as 17/28 (60.7%), 11/20 (55%) and 11/28 (39.2%) indications were confirmed for endoscopic management, ureterectomy and nephroureterectomy, respectively. CONCLUSIONS: The complementary use of computerized tomography urography and ureteroscopy in the diagnostic workup of upper tract urothelial carcinoma should be evaluated.


Subject(s)
Carcinoma, Transitional Cell/diagnostic imaging , Carcinoma, Transitional Cell/surgery , Tomography, X-Ray Computed , Ureteral Neoplasms/diagnostic imaging , Ureteral Neoplasms/surgery , Ureteroscopy , Urinary Bladder Neoplasms/diagnostic imaging , Urinary Bladder Neoplasms/surgery , Urography , Aged , Aged, 80 and over , Female , Humans , Male , Reproducibility of Results , Retrospective Studies , Treatment Outcome , Urography/methods
8.
World J Urol ; 39(6): 1717-1723, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32591902

ABSTRACT

PURPOSE: To describe the vacuum-assisted mini-percutaneous nephrolithotomy (vmPCNL) technique performed via the 16Ch ClearPetra sheath, to evaluate its outcomes and to analyze intrarenal pressure (IRP) fluctuations during surgery. METHODS: Data from all consecutive vmPCNL procedures from September 2017 to October 2019 were prospectively collected. Data included patients' and stones characteristics, intra and peri-operative items, post-operative complications and stone clearance. Patients undergoing vmPCNL from March to October 2019 were submitted to IRP measurement during surgery. RESULTS: A total of 122 vmPCNL procedures were performed. Median stone volume was 1.92 cm3. Median operative time was 90 min and median lithotripsy and lapaxy time was 28 min. Stone clearance rate was 71.3%. Thirty-one (25.2%) patients experienced post-operative complications, seven of which were Clavien 3. Postoperative fever occurred in nine (7.4%) patients and one (0.8%) needed a transfusion. No sepsis were observed. IRPs were measured in 22 procedures. Mean IRP was 15.3 cmH2O and median accumulative time with IRP > 40.78 cmH2O (pyelovenous backflow threshold) was 28.52 sec. Maximum IRP peaks were reached during the surgical steps when aspiration is closed (mainly pyelograms), whereas during lithotripsy and suction-mediated lapaxy, the threshold of 40.78 cmH2O was overcome in three procedures. CONCLUSIONS: vmPCNL is a safe procedure with satisfactory stone clearance rates. Mean IRP was always lower than the threshold of pyelo-venous backflow and the accumulative time with IRP over this limit was short in most of the procedures. During lithotripsy and vacuum-mediated lapaxy, IRP rarely raised over the threshold.


Subject(s)
Kidney Calculi/surgery , Kidney , Nephrolithotomy, Percutaneous/methods , Pressure , Adult , Aged , Equipment Design , Female , Humans , Male , Middle Aged , Nephrolithotomy, Percutaneous/instrumentation , Prospective Studies , Treatment Outcome , Vacuum
9.
Crit Care ; 25(1): 367, 2021 Oct 20.
Article in English | MEDLINE | ID: mdl-34670582

ABSTRACT

BACKGROUNDS: The large, international, randomized controlled NeoPInS trial showed that procalcitonin (PCT)-guided decision making was superior to standard care in reducing the duration of antibiotic therapy and hospitalization in neonates suspected of early-onset sepsis (EOS), without increased adverse events. This study aimed to perform a cost-minimization study of the NeoPInS trial, comparing health care costs of standard care and PCT-guided decision making based on the NeoPInS algorithm, and to analyze subgroups based on country, risk category and gestational age. METHODS: Data from the NeoPInS trial in neonates born after 34 weeks of gestational age with suspected EOS in the first 72 h of life requiring antibiotic therapy were used. We performed a cost-minimization study of health care costs, comparing standard care to PCT-guided decision making. RESULTS: In total, 1489 neonates were included in the study, of which 754 were treated according to PCT-guided decision making and 735 received standard care. Mean health care costs of PCT-guided decision making were not significantly different from costs of standard care (€3649 vs. €3616). Considering subgroups, we found a significant reduction in health care costs of PCT-guided decision making for risk category 'infection unlikely' and for gestational age ≥ 37 weeks in the Netherlands, Switzerland and the Czech Republic, and for gestational age < 37 weeks in the Czech Republic. CONCLUSIONS: Health care costs of PCT-guided decision making of term and late-preterm neonates with suspected EOS are not significantly different from costs of standard care. Significant cost reduction was found for risk category 'infection unlikely,' and is affected by both the price of PCT-testing and (prolonged) hospitalization due to SAEs.


Subject(s)
Anti-Bacterial Agents , Clinical Decision-Making , Duration of Therapy , Health Care Costs , Sepsis , Anti-Bacterial Agents/therapeutic use , Clinical Decision-Making/methods , Early Diagnosis , Health Care Costs/statistics & numerical data , Humans , Infant, Newborn , Procalcitonin/blood , Sepsis/diagnosis , Sepsis/drug therapy
10.
BMC Pulm Med ; 21(1): 274, 2021 Aug 23.
Article in English | MEDLINE | ID: mdl-34425803

ABSTRACT

BACKGROUND: Transbronchial lung cryobiopsy is a safe technique increasingly used in the study of lung diseases. Until now, only a case of pneumatocele was described but this interesting condition is probably underestimated because CT scan is routinely not performed after transbronchial lung cryobiopsies. CASE PRESENTATION: We report a case of a woman presenting two pneumatoceles after lung cryobiopsies performed for the study of an interstitial lung disease. The finding was obtained with a CT scan performed because of the appearance of hemoptysis, four days after the biopsies. CONCLUSIONS: Small cavitations could develop after cryobiopsies in the absence of an active infection. Studies that prospectively perform CT scan of the chest in patients who have undergone these samplings could be useful to know the incidence of iatrogenic lesions.


Subject(s)
Cryosurgery/adverse effects , Hemoptysis/diagnostic imaging , Hemoptysis/etiology , Lung Diseases, Interstitial/pathology , Biopsy/adverse effects , Bronchi/pathology , Female , Humans , Lung/pathology , Middle Aged , Tomography, X-Ray Computed
11.
BMC Pulm Med ; 21(1): 327, 2021 Oct 20.
Article in English | MEDLINE | ID: mdl-34670551

ABSTRACT

BACKGROUND: Detection of small peripheral lung nodules is constantly increasing with the development of low dose computed tomography lung cancer screening programs. A tissue diagnosis is often required to confirm malignity, with endobronchial biopsies being associated with a lower pneumothorax rate than percutaneous approaches. Endoscopic diagnosis of peripheral small size lung nodules is however often challenging using traditional bronchoscopy and endobronchial ultrasound alone. New virtual bronchoscopic navigation techniques such as electromagnetic navigational bronchoscopy (ENB) have developed to improve peripheral navigation, with diagnostic yield however remaining in the 30-50% range for small lesions. Recent studies have shown the benefits of combining Cone beam computed tomography (CBCT) with ENB to improve diagnostic yield to up to 83%. The use of ENB however remains limited by disposable cost, bronchus sign dependency and inaccuracies due to CT to body divergence. CASE PRESENTATION: This case report highlights the feasibility and usefulness of CBCT-guided bronchoscopy for the sampling of lung nodules difficult to reach through traditional bronchoscopy because of nodule size and peripheral position. Procedure was scheduled in a mobile robotic hybrid operating room with patient under general anaesthesia. CBCT acquisition was performed to localize the target lesion and plan the best path to reach it into bronchial tree. A dedicated software was used to segment the lesion and the bronchial path which 3D outlines were automatically fused in real time on the fluoroscopic images to augment live guidance. Navigation to the lesion was guided with bronchoscopy and augmented fluoroscopy alone. Before the sampling, CBCT imaging was repeated to confirm the proper position of the instrument into the lesion. Four transbronchial needle aspirations (TBNA) were performed and the tissue analysis showed a primary lung adenocarcinoma. CONCLUSIONS: CBCT and augmented fluoroscopy technique is a safe and effective and has potential to improve early stage peripheral lesions endobronchial diagnostic yield without ENB. Additional studies are warranted to confirm its safety, efficacy and technical benefits, both for diagnosis of oncological and non-oncological disease and for endobronchial treatment of inoperable patients.


Subject(s)
Cone-Beam Computed Tomography/methods , Fluoroscopy/methods , Lung Neoplasms/diagnostic imaging , Adenocarcinoma of Lung/diagnostic imaging , Adenocarcinoma of Lung/pathology , Aged , Humans , Image Processing, Computer-Assisted , Lung Neoplasms/pathology , Male
12.
Crit Care ; 24(1): 589, 2020 09 29.
Article in English | MEDLINE | ID: mdl-32993751

ABSTRACT

BACKGROUND: The severity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is extremely variable, ranging from asymptomatic patients to those who develop severe acute respiratory distress syndrome (ARDS). As for now, there are still no really effective therapies for coronavirus disease 2019 (COVID-19). Some evidences suggest that tocilizumab (TCZ) may avoid the progression of severe COVID-19. The aim of this retrospective case-control study was to analyze the efficacy and safety of TCZ in patients with COVID-19 ARDS undergoing noninvasive mechanical ventilation (NIV). METHODS: Seventy-nine consecutive patients with severe COVID-19 pneumonia and worsening acute respiratory failure (ARF) were admitted to the Pulmonology Unit of Azienda USL of Reggio Emilia-IRCCS. All patients were inflamed (elevated CRP and IL-6 levels) and received NIV at admission according to the presence of a pO2/FiO2 ratio ≤ 200 mmHg. The possibility of being treated with TCZ depended on the drug availability. The primary outcome was the in-hospital mortality rate. A secondary composite outcome of worsening was represented by the patients who died in the pulmonology unit or were intubated. RESULTS: Out of 79 patients, 41 were treated with TCZ. Twenty-eight patients received intravenous (IV) TCZ and 13 patients received subcutaneous (SC) TCZ. In-hospital overall mortality rate was 38% (30/79 patients). The probabilities of dying and being intubated during the follow-up using Kaplan-Meier method were significantly lower in total patients treated with TCZ compared to those of patients not treated with TCZ (log-rank p value = 0.006 and 0.036, respectively). However, using Cox multivariate analyses adjusted for age and Charlson comorbidity index only the association with the reduced risk of being intubated or dying maintained the significance (HR 0.44, 95%CI 0.22-0.89, p = 0.022). Two patients treated with TCZ developed cavitating lung lesions during the follow-up. CONCLUSIONS: This study shows that TCZ treatment may be effective in COVID-19 patients with severe respiratory impairment receiving NIV. More data on safety are required. Randomized controlled trials are needed to confirm these results.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Coronavirus Infections/therapy , Noninvasive Ventilation , Pneumonia, Viral/therapy , Respiratory Distress Syndrome/therapy , Respiratory Distress Syndrome/virology , Aged , Betacoronavirus , COVID-19 , Case-Control Studies , Female , Humans , Male , Middle Aged , Pandemics , Retrospective Studies , SARS-CoV-2
13.
Lancet ; 390(10097): 871-881, 2017 Aug 26.
Article in English | MEDLINE | ID: mdl-28711318

ABSTRACT

BACKGROUND: Up to 7% of term and late-preterm neonates in high-income countries receive antibiotics during the first 3 days of life because of suspected early-onset sepsis. The prevalence of culture-proven early-onset sepsis is 0·1% or less in high-income countries, suggesting substantial overtreatment. We assess whether procalcitonin-guided decision making for suspected early-onset sepsis can safely reduce the duration of antibiotic treatment. METHODS: We did this randomised controlled intervention trial in Dutch (n=11), Swiss (n=4), Canadian (n=2), and Czech (n=1) hospitals. Neonates of gestational age 34 weeks or older, with suspected early-onset sepsis requiring antibiotic treatment were stratified into four risk categories by their treating physicians and randomly assigned [1:1] using a computer-generated list stratified per centre to procalcitonin-guided decision making or standard care-based antibiotic treatment. Neonates who underwent surgery within the first week of life or had major congenital malformations that would have required hospital admission were excluded. Only principal investigators were masked for group assignment. Co-primary outcomes were non-inferiority for re-infection or death in the first month of life (margin 2·0%) and superiority for duration of antibiotic therapy. Intention-to-treat and per-protocol analyses were done. This trial was registered with ClinicalTrials.gov, number NCT00854932. FINDINGS: Between May 21, 2009, and Feb 14, 2015, we screened 2440 neonates with suspected early-onset sepsis. 622 infants were excluded due to lack of parental consent, 93 were ineligible for reasons unknown (68), congenital malformation (22), or surgery in the first week of life (3). 14 neonates were excluded as 100% data monitoring or retrieval was not feasible, and one neonate was excluded because their procalcitonin measurements could not be taken. 1710 neonates were enrolled and randomly assigned to either procalcitonin-guided therapy (n=866) or standard therapy (n=844). 1408 neonates underwent per-protocol analysis (745 in the procalcitonin group and 663 standard group). For the procalcitonin group, the duration of antibiotic therapy was reduced (intention to treat: 55·1 vs 65·0 h, p<0·0001; per protocol: 51·8 vs 64·0 h; p<0·0001). No sepsis-related deaths occurred, and 9 (<1%) of 1710 neonates had possible re-infection. The risk difference for non-inferiority was 0·1% (95% CI -4·6 to 4·8) in the intention-to-treat analysis (5 [0·6%] of 866 neonates in the procalcitonin group vs 4 [0·5%] of 844 neonates in the standard group) and 0·1% (-5·2 to 5·3) in the per-protocol analysis (5 [0·7%] of 745 neonates in the procalcitonin group vs 4 [0·6%] of 663 neonates in the standard group). INTERPRETATION: Procalcitonin-guided decision making was superior to standard care in reducing antibiotic therapy in neonates with suspected early-onset sepsis. Non-inferiority for re-infection or death could not be shown due to the low occurrence of re-infections and absence of study-related death. FUNDING: The Thrasher Foundation, the NutsOhra Foundation, the Sophia Foundation for Scientific research.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Calcitonin/blood , Decision Making , Sepsis/blood , Sepsis/drug therapy , Biomarkers/blood , Drug Monitoring/methods , Early Diagnosis , Female , Gestational Age , Humans , Infant , Infant, Newborn , Infant, Newborn, Diseases/blood , Infant, Newborn, Diseases/diagnosis , Infant, Newborn, Diseases/drug therapy , Internationality , Male , Sepsis/diagnosis , Time Factors , Treatment Outcome
14.
Curr Opin Urol ; 28(4): 392-397, 2018 07.
Article in English | MEDLINE | ID: mdl-29697470

ABSTRACT

PURPOSE OF REVIEW: Postbiopsy infections (PBIs) are among the most common complications associated with transrectal ultrasound-guided prostate biopsy (TRUSPB). This article discusses the pathogenesis of TRUSPB-associated infectious complications and reviews the most recent findings on techniques to prevent PBIs. RECENT FINDINGS: Risk stratification is a powerful tool for identifying TRUSPB candidates whom warrant additional preventive measures. Bowel preparation with povidone-iodine-based enemas and needle disinfection with formalin solution are simple and attractive strategies, but their effectiveness needs to be thoroughly assessed. Antibiotic prophylaxis represents the mainstay for the prevention of PBIs: the prophylactic regimen must respect the principles of antimicrobial stewardship, and local antibiotic resistance patterns among uropathogens should always be considered. Augmented and targeted antibiotic prophylaxes are powerful options, but their role in current clinical practice has yet to be clarified. The transperineal approach has shown a near-zero rate of PBIs, and should therefore be considered for the highest-risk patients. SUMMARY: Several procedures have been introduced to prevent TRUSPB-related infectious complication, but their utility and applicability in the clinical practice has yet to be elucidated. More robust evidence based on randomized control trials is needed to establish the efficacy of these tools in improving patient outcomes.


Subject(s)
Antibiotic Prophylaxis/methods , Postoperative Complications/prevention & control , Prostatic Neoplasms/diagnosis , Sepsis/prevention & control , Urinary Tract Infections/prevention & control , Biopsy, Large-Core Needle/adverse effects , Biopsy, Large-Core Needle/methods , Cathartics/administration & dosage , Humans , Image-Guided Biopsy/adverse effects , Image-Guided Biopsy/methods , Male , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prostate/pathology , Prostatic Neoplasms/pathology , Rectum/microbiology , Rectum/surgery , Sepsis/epidemiology , Sepsis/etiology , Ultrasonography, Interventional , Urinary Tract Infections/epidemiology , Urinary Tract Infections/etiology
15.
Crit Care ; 22(1): 109, 2018 Apr 27.
Article in English | MEDLINE | ID: mdl-29703214

ABSTRACT

BACKGROUND: Ultrasound (US) evaluation of diaphragmatic dysfunction (DD) has proved to be a reliable technique in critical care. In this single-center prospective study, we investigated the impact of US-assessed DD on noninvasive ventilation (NIV) failure in patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and its correlation with the transdiaphragmatic pressure assessed using the invasive sniff maneuver (Pdi sniff). METHODS: A population of 75 consecutive patients with AECOPD with hypercapnic acidosis admitted to our respiratory intensive care unit (RICU) were enrolled. Change in diaphragm thickness (ΔTdi) < 20% during tidal volume was the predefined cutoff for identifying DD+/- status. Correlations between ΔTdi < 20% NIV failure and other clinical outcomes were investigated. Correlation between ΔTdi and Pdi sniff values was analyzed in a subset of ten patients. RESULTS: DD+ patients had a higher risk for NIV failure than DD- patients (risk ratio, 4.4; p <  0.001), and this finding was significantly associated with higher RICU, in-hospital, and 90-day mortality rates; longer mechanical ventilation duration; higher tracheostomy rate; and longer RICU stay. Huge increases in NIV failure (HR, 6.2; p < 0.0001) and 90-day mortality (HR, 4.7; p = 0.008) in DD+ patients were found by Kaplan-Meier analysis. ΔTdi highly correlated with Pdi sniff (Pearson's r = 0.81; p = 0.004). ΔTdi < 20% showed better accuracy in predicting NIV failure than baseline pH value and early change in both arterial blood pH and partial pressure of carbon dioxide following NIV start (AUCs 0.84 to DTdi < 20%, 0.51 to pH value at baseline, 0.56 to early change in arterial blood pH following NIV start, and 0.54 to early change in partical pressure of carbon dioxide following NIV start, respectively; p < 0.0001). CONCLUSIONS: Early and noninvasive US assessment of DD during severe AECOPD is reliable and accurate in identifying patients at major risk for NIV failure and worse prognosis.


Subject(s)
Diaphragm/pathology , Noninvasive Ventilation/standards , Patient Outcome Assessment , Pulmonary Disease, Chronic Obstructive/therapy , APACHE , Aged , Aged, 80 and over , Cohort Studies , Diagnosis , Diaphragm/anatomy & histology , Diaphragm/physiopathology , Female , Humans , Intensive Care Units/organization & administration , Intensive Care Units/statistics & numerical data , Italy , Kaplan-Meier Estimate , Male , Noninvasive Ventilation/methods , Prospective Studies , Simplified Acute Physiology Score , Statistics, Nonparametric , Ultrasonography/methods
16.
Arch Ital Urol Androl ; 90(2): 130-135, 2018 Jun 30.
Article in English | MEDLINE | ID: mdl-29974723

ABSTRACT

OBJECTIVES: The superiority of microdissection testicular sperm extraction (mTESE) over conventional TESE (cTESE) for men with non-obstructive azoospermia (NOA) is debated. We aimed to compare the sperm retrieval rate (SRR) of mTESE to cTESE and to identify candidates who would most benefit from mTESE in a cohort of Caucasian-European men with primary couple's infertility. MATERIAL AND METHODS: Data from 49 mTESE and 96 cTESE patients were analysed. We collected demographic and clinical data, serum levels of LH, FSH and total testosterone. Patients with abnormal karyotyping were excluded from analysis. Age was categorized according to the median value of 35 years. FSH values were dichotomized according to multiples of the normal range (N) (N and 1.5 N: 1-18 mIU/mL, and > 18 mIU/mL). Testicular histology was recorded for each patient. Descriptive statistics and logistic regression analyses tested the impact of potential predictors on positive SRR in both groups. RESULTS: No differences were found between groups in terms of clinical and hormonal parameters with the exception of FSH values that were higher in mTESE patients (p = 0.004). SRR were comparable between mTESE and cTESE (49.0% vs. 41.7%, p = 0.40). SRRs were significantly higher after mTESE in patients with Sertoli cell-only syndrome (SCOS) (p = 0.038), in those older than 35 years (p = 0.03) and with FSH >1.5N (p < 0.001), as compared to men submitted to cTESE. Multivariable logistic regression analysis showed that mTESE was independent predictor of positive SR in patients older than 35 years (p = 0.002) and with FSH > 1.5N (p = 0.018). Moreover, increased FSH levels (p = 0.03) and both SCOS (p = 0.01) and MA histology (p = 0.04) were independent predictors of SRR failure. CONCLUSIONS: Microdissection and cTESE showed comparable success rates in our cohort of patients with NOA. mTESE seems beneficial for patients older than 35 years, with high FSH values, or when SCOS can be predicted. Given the high costs associated with the mTESE approach, the identification of candidates most likely to benefit from this procedure is a major clinical need.


Subject(s)
Azoospermia/surgery , Infertility, Male/surgery , Microdissection/methods , Sperm Retrieval , Spermatozoa , Testis/surgery , Adult , Cohort Studies , Cross-Sectional Studies , Follicle Stimulating Hormone/blood , Humans , Luteinizing Hormone/blood , Male , Middle Aged , Sertoli Cell-Only Syndrome/surgery , Testosterone/blood , Young Adult
18.
Comput Methods Programs Biomed ; 244: 107937, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38006707

ABSTRACT

BACKGROUND AND OBJECTIVE: Safety of robotic surgery can be enhanced through augmented vision or artificial constraints to the robotl motion, and intra-operative depth estimation is the cornerstone of these applications because it provides precise position information of surgical scenes in 3D space. High-quality depth estimation of endoscopic scenes has been a valuable issue, and the development of deep learning provides more possibility and potential to address this issue. METHODS: In this paper, a deep learning-based approach is proposed to recover 3D information of intra-operative scenes. To this aim, a fully 3D encoder-decoder network integrating spatio-temporal layers is designed, and it adopts hierarchical prediction and progressive learning to enhance prediction accuracy and shorten training time. RESULTS: Our network gets the depth estimation accuracy of MAE 2.55±1.51 (mm) and RMSE 5.23±1.40 (mm) using 8 surgical videos with a resolution of 1280×1024, which performs better compared with six other state-of-the-art methods that were trained on the same data. CONCLUSIONS: Our network can implement a promising depth estimation performance in intra-operative scenes using stereo images, allowing the integration in robot-assisted surgery to enhance safety.


Subject(s)
Robotic Surgical Procedures , Motion
19.
Neural Netw ; 178: 106469, 2024 Oct.
Article in English | MEDLINE | ID: mdl-38925030

ABSTRACT

Robot-assisted surgery is rapidly developing in the medical field, and the integration of augmented reality shows the potential to improve the operation performance of surgeons by providing more visual information. In this paper, we proposed a markerless augmented reality framework to enhance safety by avoiding intra-operative bleeding, which is a high risk caused by collision between surgical instruments and delicate blood vessels (arteries or veins). Advanced stereo reconstruction and segmentation networks are compared to find the best combination to reconstruct the intra-operative blood vessel in 3D space for registration with the pre-operative model, and the minimum distance detection between the instruments and the blood vessel is implemented. A robot-assisted lymphadenectomy is emulated on the da Vinci Research Kit in a dry lab, and ten human subjects perform this operation to explore the usability of the proposed framework. The result shows that the augmented reality framework can help the users to avoid the dangerous collision between the instruments and the delicate blood vessel while not introducing an extra load. It provides a flexible framework that integrates augmented reality into the medical robotic platform to enhance safety during surgery.


Subject(s)
Augmented Reality , Robotic Surgical Procedures , Humans , Robotic Surgical Procedures/methods , Surgery, Computer-Assisted/methods , Imaging, Three-Dimensional
20.
Urology ; 184: 149-156, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38092326

ABSTRACT

OBJECTIVE: To report oncological outcomes after thulium-yttrium-aluminum-garnet (Tm:YAG) laser ablation for penile cancer patients. MATERIALS AND METHODS: We retrospectively analyzed 71 patients with ≤cT1 penile cancer (2013-2022). All patients underwent Tm:YAG ablation with a RevoLix 200W continuous-wave laser. First, Kaplan-Meier plots and multivariable Cox regression models tested local tumor recurrence rates. Second, Kaplan-Meier plots tested progression-free survival (≥T3 and/or N1-3 and/or M1). RESULTS: Median (interquartile range) follow-up time was 38 (22-58) months. Overall, 33 (50.5%) patients experienced local tumor recurrence. Specifically, 19 (29%) vs 9 (14%) vs 5 (7.5%) patients had 1 vs 2 vs 3 recurrences over time. In multivariable Cox regression models, a trend for higher recurrence rates was observed for G3 tumors (hazard ratio:6.1; P = .05), relative to G1. During follow-up, 12 (18.5%) vs 4 (6.0%) vs 2 (3.0%) men were retreated with 1 vs 2 vs 3 Tm:YAG laser ablations. Moreover, 11 (17.0%) and 3 (4.5%) patients underwent glansectomy and partial/total penile amputation. Last, 5 (7.5%) patients experienced disease progression. Specifically, TNM stage at the time of disease progression was: (1) pT3N0; (2) pT2N2; (3) pTxN3; (4) pT1N1 and (5) pT3N3, respectively. CONCLUSION: Tm:YAG laser ablation provides similar oncological results as those observed by other penile-sparing surgery procedures. In consequence, Tm:YAG laser ablation should be considered a valid alternative for treating selected penile cancer patients.


Subject(s)
Aluminum , Laser Therapy , Lasers, Solid-State , Penile Neoplasms , Yttrium , Male , Humans , Female , Penile Neoplasms/surgery , Thulium , Lasers, Solid-State/therapeutic use , Neoplasm Recurrence, Local , Retrospective Studies , Disease Progression
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