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BACKGROUND: The majority of opioid overdose admissions in pediatric patients are associated with prescription opioids. Post-operative prescriptions are an addressable source of opioids in the household. This study aims to assess for sustained reduction in opioid prescribing after implementation of provider-based education at nine centers. METHODS: Opioid prescribing information was collected for pediatric patients undergoing umbilical hernia repair at nine centers between December 2018 and January 2019, one year after the start of an education intervention. This was compared to prescribing patterns in the immediate pre- and post-intervention periods at each of the nine centers. RESULTS: In the current study period, 29/127 (22.8%) patients received opioid prescriptions (median 8 doses) following surgery. There were no medication refills, emergency department returns or readmissions related to the procedure. There was sustained reduction in opioid prescribing compared to pre-intervention (22.8% vs 75.8% of patients, p

Background Peritoneal metastases carry the worst prognosis among all sites of colorectal cancer (CRC) metastases. In recent years, the advent of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has improved survival for selected patients with limited peritoneal involvement. We report the evolution of CRS and HIPEC for colorectal peritoneal metastases at a tertiary referral center over a 10-year period. Methods Patients with colorectal peritoneal metastases undergoing CRS and HIPEC were included and retrospectively analyzed at a tertiary referral center from January 2006 to December 2015. Main outcomes included evaluation of grade III/IV complications, mortality rate, overall and disease-free survival, and prognostic factors influencing survival on a Cox multivariate analysis. Results Sixty-seven CRSs were performed on 67 patients during this time for colorectal peritoneal metastases. The median patient age was 57 years with 55.2% being female. The median peritoneal carcinomatosis index (PCI) was 7, with complete cytoreduction achieved in 65 (97%) cases. Grade > 2 complications occurred in 6 cases (8.9%) with no mortality. The median overall survival for the entire cohort was 41 months, with a 3-year overall survival of 43%. In case of complete cytoreduction, median overall and disease-free survival were 57 months and 36 months respectively, with a 3-year disease-free survival of 62%. Complete cytoreduction and nonmucinous histology were key factors independently associated with improved overall survival. Conclusions CRS and HIPEC for limited peritoneal metastases from CRC are safe and effective, with acceptable morbidity. In selected patients, it offers a highly favorable long-term outcomes.

While anticoagulation and its reversal have been of clinical relevance for decades, recent academic and technological advances have expanded the repertoire of its application in neurological disease. The advent of direct oral anticoagulants provides effective, mechanistically elegant, and relatively safer therapeutic options than warfarin for eligible patients at risk for neurological sequelae of prothrombotic states, particularly given the recent availability of corresponding reversal agents. In this review, we examine the provenance, indications, safety, and reversal tools for anticoagulant medications in the context of neurological disease, with specific attention to acute ischemic stroke, cerebral venous sinus thrombosis, and intracerebral hemorrhage. We will use specific clinical scenarios to illustrate the complex factors that must be considered in the use of anticoagulation, including intracranial pathology such as intracerebral hemorrhage, traumatic brain injury, or malignancy; metabolic complications such as chronic kidney disease; pregnancy; and advanced age.

Uterine fibroids embolization is a safe and effective organ sparing treatment for fibroid-related symptoms based on a broad range of published evidence including randomized-controlled trials. Indication to treatment is usually the presence of symptomatic uterine fibroids. In this review, a systematic search of journal articles relevant to the treatment of symptomatic uterine fibroids was conducted, with a special focus on the indication to treatment, technique, procedural outcomes and pain control. All clinical trials published in English language, representing original research, and reporting clinical outcomes associated with interventions for the management of symptomatic uterine fibroids were considered.

Gastric cancer is the third most common cause of cancer related death. Although its incidence is globally declined, prognosis remains dismal in the Western hemisphere, while better outcomes are evidenced in Asian countries. Endoscopic or surgical resection with or without lymphadenectomy represents the only chance of cure, with limited improvements of the prognosis in case of associated chemotherapy in a neoadjuvant or adjuvant setting. This could be mainly attributed to the uniform fashion of treatment of gastric cancer, mainly based on the histological features, that usually do not reflect the complexity of the disease. With the recent introduction of genomic technologies and new generation sequencing techniques, gastric cancer biology is now investigated in great details. This has brought to the publication of three main molecular classifications, based on the underlying molecular biology of gastric cancer. Although only few clinical reports are currently present in literature, the identification of gastric cancer molecular subtypes has shown interesting findings that may pave the way to a tailored clinical and surgical management. The aim of this review is, thus, to give a comprehensive overview of the current molecular classifications as compared to the available histopathological ones, also focusing on the potential clinical and surgical benefits and the future perspectives for a more personalized treatment of gastric cancer.

To investigate the accuracy of ultrasound in characterising the type of mass and likelihood of malignancy in deep soft tissue masses. Five hundred seventy-nine deep soft tissue masses were prospectively studied by ultrasound. Masses (n = 137) with prior MRI or CT were not included. Following ultrasound examination, the likely nature of the mass as well as the confidence of the reporting radiologist (‘fully confident’ versus ‘not fully confident’) about the ultrasound diagnosis was recorded. Clinical and ultrasound diagnoses were compared with the histological diagnosis which was available in 134 (23%) of the 579 masses. Compared with histology, clinical and ultrasound accuracy for characterising the type of mass were 47% and 88% respectively when all differential diagnoses were considered. The radiologist was fully confident regarding the type of 436 (75%) of 579 masses and, in this setting, for those cases that could be compared with histology, diagnostic accuracy was 96%. For the remaining masses, where the radiologist was not fully confident, accuracy compared with histology was 58% for the first differential diagnosis and 80% for all differential diagnoses. For identifying malignancy, sensitivity, specificity, and positive and negative predictive value of ultrasound were 97%, 58%, 67%, and 99% respectively. Ultrasound alone was considered sufficient for diagnostic workup in over half of all deep soft tissue masses. Ultrasound is useful at characterising and recognising malignancy in deep soft tissue masses. Provided local practice patterns are favourable, ultrasound may be considered a first-line investigation in the diagnostic workup of deep soft tissue masses. • In three-quarters of cases, one can be fully confident about characterising the nature of deep soft tissue masses on ultrasound and, for those fully confident cases that could be compared with histology, the diagnostic accuracy of ultrasound was 96%. • Ultrasound can correctly recognise nearly all malignant deep soft tissue masses but some benign masses will also be considered possibly malignant. • Ultrasound alone was considered sufficient for imaging workup in over half of deep soft tissue masses.

To date there is limited data on the immune profile and outcomes of solid organ transplant recipients who encounter COVID-19 infection early post-transplant. Here we present a unique case where the kidney recipient’s transplant surgery coincided with a positive SARS-CoV-2 test and the patient subsequently developed symptomatic COVID-19 perioperatively. We performed comprehensive immunological monitoring of cellular, proteomic, and serological changes during the first 4 critical months post-infection. We showed that continuation of basiliximab induction and maintenance of triple immunosuppression did not significantly impair the host’s ability to mount a robust immune response against symptomatic COVID-19 infection diagnosed within the first week post-transplant.

The European Society of Gynaecological Oncology (ESGO) developed and established for the first time in 2016, and updated in 2020, quality indicators for advanced ovarian cancer surgery to audit and improve clinical practice in Europe and beyond. As a sequela of the continuous effort to improve oncologic care in patients with ovarian cancer, ESGO issued in 2018 a consensus guidance jointly with the European Society of Medical Oncology addressing in a multidisciplinary fashion 20 selected key questions in the management of ovarian cancer, ranging from molecular pathology to palliation in primary and relapse disease. In order to complement the above achievements and consolidate the promoted systemic advances and surgical expertise with adequate peri-operative management, ESGO developed, as the next step, clinically relevant and evidence-based guidelines focusing on key aspects of peri-operative care and management of complications as part of its mission to improve the quality of care for women with advanced ovarian cancer and reduce iatrogenic morbidity. To do so, ESGO nominated an international multidisciplinary development group consisting of practicing clinicians and researchers who have demonstrated leadership and expertise in the care and research of ovarian cancer (18 experts across Europe). To ensure that the guidelines are evidence based, the literature published since 2015, identified from a systematic search, was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the development group. The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 117 independent international practitioners in cancer care delivery and patient representatives.

BACKGROUND Although minimally-invasive techniques are currently recognized as effective and validated treatment for small gastric gastrointestinal stromal tumors (GISTs), the role of laparoscopy is not yet established. The aim of this study was to evaluate the outcomes of laparoscopic treatment of gastric GISTs compared to the results obtained in a group of patients treated with conventional surgery. METHODS A retrospective analysis was performed, using a prospectively maintained comprehensive database of 100 patients treated for gastric GIST in the period from 2000 to 2015. Thirty-six patients were treated laparoscopically, and 64 patients underwent conventional surgery. The analyzed medical data included clinical and pathological features of removed tumors, perioperative parameters as well as short and long-term results of surgical treatment. RESULTS Histopathological examination confirmed radical resections for all patients. No deaths were reported in the 90-day postoperative period. Patients in laparoscopic group had significantly shorter length of hospital stay (5.5 vs. 7 days, P

A major clinical challenge in adolescent idiopathic scoliosis (AIS) is the difficulty of predicting curve progression at initial presentation. The early detection of progressive curves can offer the opportunity to better target effective non-operative treatments, reducing the need for surgery and the risks of related complications. Predictive models for the detection of scoliosis progression in subjects before growth spurt have been developed. These models accounted for geometrical parameters of the global spine and local descriptors of the scoliotic curve, but neglected contributions from biomechanical measurements such as trunk muscle activation and intervertebral loading, which could provide advantageous information. The present study exploits a musculoskeletal model of the thoracolumbar spine, developed in AnyBody software and adapted and validated for the subject-specific characterization of mild scoliosis. A dataset of 100 AIS subjects with mild scoliosis and in pre-pubertal age at first examination, and recognized as stable (60) or progressive (40) after at least 6-months follow-up period was exploited. Anthropometrical data and geometrical parameters of the spine at first examination, as well as biomechanical parameters from musculoskeletal simulation replicating relaxed upright posture were accounted for as predictors of the scoliosis progression. Predicted height and weight were used for model scaling because not available in the original dataset. Robust procedure for obtaining such parameters from radiographic images was developed by exploiting a comparable dataset with real values. Six predictive modelling approaches based on different algorithms for the binary classification of stable and progressive cases were compared. The best fitting approaches were exploited to evaluate the effect of accounting for the biomechanical parameters on the prediction of scoliosis progression. The performance of two sets of predictors was compared: accounting for anthropometrical and geometrical parameters only; considering in addition the biomechanical ones. Median accuracy of the best fitting algorithms ranged from 0.76 to 0.78. No differences were found in the classification performance by including or neglecting the biomechanical parameters. Median sensitivity was 0.75, and that of specificity ranged from 0.75 to 0.83. In conclusion, accounting for biomechanical measures did not enhance the prediction of curve progression, thus not supporting a potential clinical application at this stage., Frontiers in Bioengineering and Biotechnology, 9, ISSN:2296-4185

Background Opioid misuse has reached epidemic proportions, and postoperative opioids have been linked to overdose, diversion, and dependency. We recently found our opioid prescribing practices following common pediatric operations to be inconsistent and excessive. In this study, we evaluate the efficacy of an educational intervention on opioid prescriptions following tonsillectomy and hernia repair. Methods Retrospective chart review of prescriptions following outpatient tonsillectomies and hernia repairs at a single institution before and after an educational intervention was performed. The intervention consisted of a single campus-wide grand rounds presentation detailing the surgeon's role in the opioid epidemic. Results Postoperative opioid prescriptions were significantly reduced for hernia repair following the educational intervention: 4.2 ± 2.9 vs 2.7 ± 2.6 days' supply (p = 0.004). Such a reduction was not observed for post-tonsillectomy opioid prescriptions: 6.3 ± 4.4 vs 5.4 ± 3.0 days' supply (p = 0.226). A greater decrease in interprovider variation was observed for hernia providers after the educational intervention than for tonsillectomy providers, though significant variation continued to be present for both procedures after the intervention. Conclusions The efficacy of an educational intervention at reducing postoperative pediatric opioid prescribing may be tied to the specialty-specific role model relationship of the educator to the prescriber. Type of study: retrospective comparative chart review. Level of evidence: IV.

To study MRI criteria for diagnosing and predicting severity of carpal tunnel syndrome (CTS). Sixty-nine wrists in 41 symptomatic CTS patients and 32 wrists in 28 asymptomatic subjects were evaluated by MRI. Circumferential surface area (CSA), flattening ratio, relative median nerve signal intensity, and retinacular bowing were measured. CTS severity was classified as mild, moderate, or severe. Parameters for patients with and without CTS and for the three severity groups were compared. ROC curves were plotted to assess accuracy for CTS diagnosis and severity prediction. Significant differences were found between CTS and control wrists for median nerve CSA, flattening ratio at inlet, relative median nerve signal intensity, and retinacular bowing. ROC curve analysis revealed a sensitivity, specificity, and accuracy of median nerve CSA > 15 mm2 proximal to the tunnel (CSAp) of 85.5, 100, and 90.1%. Using either CSAp or CSAd > 15 mm2 as a diagnostic criterion, MRI could achieve a sensitivity of 100% and specificity of 94% for diagnosis of CTS while overall accuracy was 98%. Significant differences were found among the three severity groups. Sensitivity, specificity, and accuracy of prediction of severe CTS using for CSAp > 19 mm2 were 75.0, 65.9, and 69.6%, respectively. MRI is highly accurate at diagnosing CTS and moderately accurate at determining CTS severity. We recommend using CSA > 15 mm2 either proximal to or distal to the tunnel as a diagnostic criterion for CTS and CSA > 19 mm2 proximal to the tunnel as a marker for severe CTS.

Minimally invasive surgery (MIS) is gaining popularity in rectal tumor treatment. However, contrasting data are available regarding its safety and efficacy. Our aim is to compare the open and MIS approaches for rectal cancer treatment. Two-hundred-thirty-seven patients were included: 113 open and 124 MIS rectal resections. After the propensity score matching analysis (PS), the cases were matched into 42 open and 42 MIS. Short- and long-term outcomes, and pathological findings were analyzed before and after PS. A further comparison of the same outcomes and costs was conducted between the laparoscopic and the robotic approaches. As a whole, a sphincter-preserving procedure was more frequently performed in the MIS group (110 vs 75 cases; p

Background Crohn's disease (CD) has a multitude of complications including intestinal strictures from fibrostenotic disease. Fibrostenotic disease has been reported in 10%-17% of children at presentation and leads to surgery in 20%-50% of cases within ten years of diagnosis. When symptoms develop from these strictures, the treatment in children has primarily been surgical resection. Endoscopic balloon dilation (EBD) has been shown to be a safe and efficacious alternative to surgery in adults, but evidence is poor in the literature regarding its safety and efficacy in children. Aim To evaluate the outcomes of children with fibrostenosing CD who underwent EBD vs surgery as a treatment. Methods In a single-center retrospective study, we looked at pediatric patients (ages 0-18) who carry the diagnosis of CD, who were diagnosed after opening a dedicated Inflammatory Bowel Disease clinic on July 1, 2012 through May 1, 2019. We used diagnostic codes through our electronic medical record to identify patients with CD with a stricturing phenotype. The type of intervention for patients' strictures was then identified through procedural and surgical billing codes. We evaluated their demographics, clinical variables, whether they underwent EBD vs surgery or both, and their clinical outcomes. Results Of the 139 patients with CD, 25 (18%) developed strictures. The initial intervention for a stricture was surgical resection in 12 patients (48%) and EBD in 13 patients (52%). However, 4 (33%) patients whom initially had surgical resection required follow up EBD, and thus 17 total patients (68%) underwent EBD at some point in their treatment process. For those 8 patients who underwent successful surgical resection alone, 4 of these patients (50%) had a fistula present near the stricture site and 4 (50%) had strictures greater than 5 cm in length. All patients who underwent EBD had no procedural complications, such as a perforation. Twenty-two (88%) of the treated strictures were successfully managed by EBD and did not require any further surgical intervention during our follow up period. Conclusion EBD is safe and efficacious as an alternative to surgery for palliative management of strictures in selected pediatric patients with CD.

Parastomal recurrence of squamous cell carcinoma (SCC) with tracheal involvement following salvage total laryngectomy after prior concurrent chemoradiotherapy is one of the most insidious challenges in head and neck surgery because a complex reconstruction is often required for covering a large area of skin loss, filling the dead space beneath, tracheal reconstruction and suspension, and tracheostome resurfacing. The aim is to describe our experience with the internal mammary artery perforator (IMAP) propeller flap for tracheal and tracheostome reconstruction and neck resurfacing after parastomal and cervical trachea resection, especially for suspension and anchoring the stump of the residual distal trachea to the island flap itself. We describe IMAP flap reconstruction after resection of parastomal recurrence of SCC requiring cervical trachea resection in five patients between January 1, 2005 and August 30, 2019. IMAP propeller flap was successfully used for reconstruction after complex resection of parastomal recurrence of SCC with cervical trachea involvement in all cases. The mean length and width were, respectively, 16.8 cm (range 13–23) and 6.9 cm (range 5.5–8). We did not report complications of both the donor and the recipient site. Pharyngo-cutaneous or tracheoesophageal fistulas and wound dehiscence were not observed. to the best of our knowledge, this is the first report about the use of the IMAP propeller flap in this more complex clinical setting and we provide the message that this surgical procedure is worthy of consideration.

BACKGROUND & AIMS Sarcopenia in liver transplantation (LT) cirrhotic candidates has been connected with higher dropouts and graft losses after transplant. The study aims to create an 'urgency' model combining sarcopenia and Model for End-stage Liver Disease Sodium (MELDNa) to predict the risk of dropout and identify an appropriate threshold of post-LT futility. METHODS A total of 1087 adult cirrhotic patients were listed for a first LT during January 2012 to December 2018. The study population was split into a training (n = 855) and a validation set (n = 232). RESULTS Using a competing-risk analysis of cause-specific hazards, we created the Sarco-Model2 . According to the model, one extra point of MELDNa was added for each 0.5 cm2 /m2 reduction of total psoas area (TPA)

PURPOSE: Laparoscopic inguinal hernia repair (LIHR) has gained wide acceptance over the past decade, although studies with longer term follow-up are lacking. We present one of the largest cohorts of children undergoing laparoscopic needle-assisted repair (LNAR) with long-term follow-up. METHODS: A clinical quality database was maintained for children

We investigated the accuracy of digital breast tomosynthesis compared to full-field digital mammography for evaluating tumor-free resection margins in the intraoperative specimen during breast-conserving surgery, reducing re-excision rates. In total, 170 patients, with proven breast cancer and eligible for breast-conserving surgery, were enrolled. Intraoperative specimens underwent digital mammography and digital breast tomosynthesis. Two breast radiologists, with ten years of experience in breast imaging, in batch mode, evaluated tumor-free resection margins and the distance between the margins and lesion. Histopathological findings were considered the standard of reference. We used the correlation analysis to evaluate the agreement between measures of tumor-free resection margins obtained with digital mammography and the true value (histopathological findings), and between digital breast tomosynthesis and histopathological findings. The size evaluation determined by digital breast tomosynthesis was more accurately correlated with that found by pathology; the calculated Pearson’s correlation coefficient of digital breast tomosynthesis and digital mammography to the pathologically determined tumor-free resection margins were 0.92 and 0.79 in CC view and 0.92 and 0.72 in LL view, respectively. Compared with the pathologically determined tumor-free resection margins, the size determined by both imaging modalities was, on average, overestimated. Bland–Altman analysis showed an excellent inter readers agreement. Digital breast tomosynthesis is more accurate in assessment of margin status than digital mammography; it could be a more accurate technique than full-field digital mammography for the intraoperative delineating of tumor resection margins.

Robotic surgery has progressively gained popularity in the treatment of rectal cancer. However, only a few studies on its oncologic effectiveness are currently present, with contrasting results. The purpose of this study is to report a single surgeon’s experience on robotic rectal resection (RRR) for cancer, focusing on the analysis of oncologic outcomes, both in terms of pathological features and long-term results. One-hundred and twenty-two consecutive patients who underwent RRR for rectal cancer from January 2013 to December 2019 were retrospectively enrolled. Patients’ characteristics and perioperative outcomes were collected. The analyzed oncologic outcomes were pathological features [distal (DM), circumferential margin (CRM) status and quality of mesorectal excision (TME)] and long-term outcomes [overall (OS) and disease-free survival (DFS)]. The mean operative time was 275 (± 60.5) minutes. Conversion rate was 6.6%. Complications occurred in 27 cases (22.1%) and reoperation was needed in 2 patients (1.5%). The median follow-up was 30.5 (5.9–86.1) months. None presented DM positivity. CRM positivity was 2.5% (2 cases) while a complete TME was reached in 94.3% of cases (115 patients). Recurrence rate was 5.7% (2 local, 4 distant and 1 local plus distant tumor relapse). OS and DFS were 90.7% and 83%, respectively. At the multivariate analysis, both CRM positivity and near complete/incomplete TME were recognized as negative prognostic factors for OS and DFS. Under appropriate logistic and operative conditions, robotic surgery for rectal cancer proves to be oncologically effective, with adequate pathological results and long-term outcomes. It also offers acceptable peri-operative outcomes, further confirming the safety and feasibility of the technique.

Few comparative studies are available on the long-term prognostic role of mesopancreas (MP) excision after pancreaticoduodenectomy (PD). We compared the long-term outcomes of patients undergoing standard PD (sPD) and PD with MP excision (PD-MPe). Sixty sPDs were compared to 60 matched PD-MPe patients for intraoperative and postoperative data, histopathological findings, and long-term outcomes. R0 rate was similar in the two groups (p = 0.17). However, PD-MPe related to a lower rate of MP resection margin positivity (16.7% vs 5%; p = 0.04) and to a higher harvested lymph nodes number (19.8 ± 7.6 vs 10.1 ± 5.1; p

Objective: Stafne’s bone cyst (SBC) is an asymptomatic, round or oval-shaped, well-defined, uniform radiolucent lesion, usually incidentally observed in the posterior aspects of the mandible. Radiographical appearance may be confusing though. This study aimed to review the literature on SBCs and to map the SBC as shown in their respective papers. Methods: A Pubmed® search (1/9/2018 till 31/5/2019), mentioning SBC, was carried out. Included papers had to contain: patient’s age, gender and radiographs. Results: In total, 114 papers were found, but only 64 papers were retained, which contained 109 cases (95 males, 14 females). The patients’ ages ranged between 14 and 89 years old (mean age being 52 years). Male patients’ ages (N = 95) ranged from 14 to 89 years (mean age 52.3 years), whereas the females (N = 14) ages ranged between 22 and 68 (mean age 50.2 years). 28 combinations of locations of SBC were recorded. Only three lesions were located at the symphysis, six were bilateral, 55 appeared on the left hand side and 45 on the right hand side of the mandible.The literature mentioned that these cavities could contain salivary gland tissue, muscular tissue, lymphoid tissue, blood vessels, fat tissue or connective tissue. Discussion/Conclusion: This study illustrates the wide variation of SBC locations across the mandible and leads us to conclude that the differential diagnosis of every asymptomatic, oval or round, well-defined, uniform radiolucent lesion on two-dimensional radiographs of the mandible should include “a benign mandibular concavity”, formerly known as SBC.

Objective: This paper provides information about conservative surgery to correct uterine arteriovenous malformations (UAVMs). The main objectives are to review the current literature on this subject and to share our very interesting and challenging case of UAVM. Our innovative surgical approach consisted in a combined method with temporary uterine artery embolization (UAE) plus hysteroscopic treatment. Materials and Methods: A search of MEDLINE, EMBASE, Web of Sciences, Scopus, ClinicalTrial.gov, OVID and Cochrane Library was performed. Any type of study has been considered including case reports. We identify articles published from the inception to July 2019. Three hundred sixty-three articles were identified: 286 articles were excluded for any reason. Overall, 77 articles were incorporated for further assessment. Results: Four surgical techniques have been employed to treat 125 cases of UAVMs: uterine artery embolization (UAE) (69.9%),dilatation and curettage (D&C) (10.4%), operative hysteroscopy (14.4%), uterine artery ligation (4%). Two patients (1.6%) underwent combined approach. Failed procedures which required a new treatment were twenty-one (16.8%). Forty-five pregnancies after surgical conservative management of UAVMs were reported. Conclusion: UAVM is a rare condition. In literature, there is no gold standard of treatment. For young women who wish to preserve fertility, a conservative surgical management should be recommended. As in our case, using a resorbable agent to perform UAE permitted a normal restoration of the flow in the uterine artery after the hysteroscopic resection.

Background Cardiovascular complications represent the major cause of morbidity and mortality of type 2 diabetes mellitus (T2DM) patients. In particular, peripheral artery disease (PAD) represents a frequent T2DM vascular complication and a risk factor for the development of major adverse cardiovascular events (MACE). Among adipokines, omentin-1 serum levels are reduced in T2DM patients with PAD and are inversely related to disease severity. Objective To study the relationship between omentin-1 levels, at baseline, with outcomes after endovascular procedures in T2DM patients with PAD and chronic limb-threatening ischemia (CLTI). Research design and methods We enrolled for our prospective non-randomized study, 207 T2DM patients with PAD and CLTI, requiring revascularization. Omentin-1 serum levels were collected before revascularization and patients incidence outcomes were evaluated at 1, 3, 6 and 12 months. Results Omentin-1 was reduced in patients with more severe disease (27.24 ± 4.83 vs 30.82 ± 5.48 ng/mL, p vs 31.33 ± 5.29 ng/mL, p vs 31.34 ± 5.54 ng/mL, p Conclusions We demonstrated that reduced omentin-1 levels, at baseline, are related with worse vascular outcomes in T2DM patients with PAD and CLTI undergoing an endovascular procedure.

Supplemental Digital Content is available in the text., Introduction: Consistent delivery of high-quality care is a marker of health-care system reliability. Although clinically abstracted outcome databases have revolutionized surgical quality improvement efforts for many high-volume procedures, their utility in aiding the improvement of time-sensitive processes is less clear. The purpose of this study was to determine whether process measures surrounding the delivery of timely surgical care could delineate the variability in the outcome of patients with testicular torsion. Our secondary aim was to use the data to drive quality improvement efforts locally. Methods: We performed a retrospective review of encounters for testicular torsion in patients less than 18 years. Characteristics of patients undergoing detorsion/orchiopexy and orchiectomy were compared. We evaluated orchiectomy as a function of age, insurance status, time of presentation, duration of symptoms, time to ultrasound, and time to surgery. Results: Over 10 years, we identified 46 patients, of whom 21 met inclusion criteria. Twelve patients (57.1%) underwent detorsion/orchiopexy, whereas 9 patients underwent orchiectomy. After-hours presentation and age were not predictive of orchiectomy, whereas the duration of symptoms was predictive of orchiectomy. Differences in time to surgery for orchiopexy and orchiectomy groups approached but did not reach significance (P = 0.07). Conclusions: Significant variability persists in the timely delivery of comprehensive and coordinated care for children suffering from time-sensitive surgical conditions. Pediatric surgical programs would realize significant benefit from a surgical quality improvement program that incorporates validated process metrics, along with outcome measures, to help drive efficiencies and integrate care more effectively.

BackgroundMycoplasma genitalium is a common cause of non-gonococcal non-chlamydial urethritis and cervicitis. Testing of asymptomatic populations has been proposed, but prevalence in asymptomatic populations is not well established. We aimed to estimate the prevalence of M. genitalium in the general population, pregnant women, men who have sex with men (MSM), commercial sex workers (CSWs) and clinic-based samples,MethodsWe searched Embase, Medline, IndMED, African Index Medicus and LILACS from 1 January 1991 to 12 July 2016 without language restrictions. We included studies with 500 participants or more. Two reviewers independently screened and selected studies and extracted data. We examined forest plots and conducted random-effects meta-analysis to estimate prevalence, if appropriate. Between-study heterogeneity was examined using the I2 statistic and meta-regression.ResultsOf 3316 screened records, 63 were included. In randomly selected samples from the general population, the summary prevalence was 1.3% (95% CI 1.0% to 1.8%, I2 41.5%, three studies, 9091 people) in countries with higher levels of development and 3.9% (95% CI 2.2 to 6.7, I2 89.2%, three studies, 3809 people) in countries with lower levels. Prevalence was similar in women and men (P=0.47). In clinic based samples, prevalence estimates were higher, except in asymptomatic patients (0.8%, 95% CI 0.4 to 1.4, I2 0.0%, three studies, 2889 people). Summary prevalence estimates were, in the following groups: pregnant women 0.9% (95% CI 0.6% to 1.4%, I2 0%, four studies, 3472 people), MSM in the community 3.2% (95% CI 2.1 to 5.1, I2 78.3%, five studies, 3012 people) and female CSWs in the community 15.9% (95% CI 13.5 to 18.9, I2 79.9%, four studies, 4006 people).DiscussionThis systematic review can inform testing guidelines for M. genitalium. The low estimated prevalence of M. genitalium in the general population, pregnant women and asymptomatic attenders at clinics does not support expansion of testing to these groups.Registration numbersPROSPERO: CRD42015020420

To evaluate effectiveness and safety of UFE as alternative to surgery, in treatment of uterine fibromatosis. 255 patients (aged 26–55) with symptomatic UF, indication for surgery, followed in our center (2000–2014), single or multiple fibroids, pain and/or functional/compressive disorders, underwent embolization: injection of PVA particles (150–900 μm) from distal portion of uterine arteries (ascending section). Primary end-point: flow-stop distally to injection site, disappearance of lesion design, preservation of flow in main trunk of UA. Secondary end-point: control of pain and functional/compressive disorders during follow-up (2–7 years). Procedure was performed bilaterally in 250 patients (98%). Mean duration: 47 min (average fluoroscopy: 10:50 min). Post-embolization pelvic pain (according with VAS score) was on average 2.2 at discharge (24 h). Follow-up at 2 years: resolution of menstrual disorders in 78% of patients and improvement in 14%; pain disappeared in 66%; significant improvement of menstrual flow and HCT/HB levels, decrease in total uterine (57.7%)/dominant fibroid (76.1%) volume. Recurrence in 18 patients. UFE represents an excellent alternative to surgical treatment: it is safe, tolerable and effective both in short and long term, with evident advantages in economic and social terms.

Ovarian teratoma is the most common ovarian tumor in children with an overall incidence of 2.6 cases per 100,000 girls per year. Diagnosis and management are challenging due to its nonspecific presentation, malignancy determination, and need to conserve fertility. A previously healthy 5-month-old female infant presented with fever, abdominal distension, and nonbilious emesis, and an 8.2 × 6.8 × 6.1-centimeter pelvic mass originating from the left adnexa was found on imaging. Due to concern for malignancy and torsion, exploratory laparotomy and ovarian-sparing surgery (OSS) with resection of the mass were performed. Histology showed a grade 1 teratoma. This case illustrates a challenging diagnosis and its symptom overlap with other etiologies in infants. The keys to diagnosing and managing this entity are including ovarian pathology in the differential diagnosis and performing OSS whenever possible. Furthermore, ultrasound follow-up is needed to monitor for ipsilateral and contralateral ovarian tumors later in life.

We studied a family in which the first-born child, a girl, had developmental delay, facial dysmorphism, and agenesis of the corpus callosum (ACC). The subsequent pregnancy was interrupted as the fetus was found to be also affected by ACC. Both cases were heterozygous for two KDM5B variants predicting p (Ala635Thr) and p (Ser1155AlafsTer4) that were shown to be in trans. KDM5B variants have been previously associated with moderate to severe developmental delay/intellectual disability (DD/ID), autism spectrum disorders (ASD), and dysmorphism in a few individuals, but the pathogenetic mechanisms are not clear yet as patients with both monoallelic and biallelic variants have been observed. Interestingly, one individual has previously been reported with ACC and severe ID in association with biallelic KDM5B variants. Together with the observations in this family, this suggests that agenesis of the corpus callosum may be part of the phenotypic spectrum associated with KDM5B variants and that the KDM5B gene should be included in gene panels to clarify the etiology of ACC both in the prenatal and postnatal setting.

There is still a lack of knowledge concerning the pathophysiology of death among COVID-19-deceased patients, and the question of whether a patient has died with or due to COVID-19 is still very much debated. In Italy, all deaths of patients who tested positive for SARS-CoV-2 are defined as COVID-19-related, without considering pre-existing diseases that may either contribute to or even cause death. Our study included nine subjects from two different nursing homes (Cases 1–4, Group A, Cases 5–9, Group B). The latter included patients who presumably died from CO poisoning due to a heating system malfunction. All subjects tested positive for COVID-19 both ante- and post-mortem and were examined using post-mortem computed tomography prior to autopsy. COVID-19 was determined to be a contributing cause in the deaths of four out of nine subjects (death due to COVID-19, i.e., pneumonia and sudden cardiac death). In the other five cases, for which CO poisoning was identified as the cause of death, the infection presumably had no role in exitus (death with COVID-19). In our attempt to classify our patients as dying with or due to COVID-19, we found the use of complete assessments (both histological analyses and computed tomography examination) fundamental.

Background and aim COVID-19 is an extremely challenging disease, both from a clinical and forensic point of view, and performing autopsies of COVID-19 deceased requires adequately equipped sectorial rooms and exposes health professionals to the risk of contagion. Among one of the categories that are most affected by SARS-Cov-2 infection are the elderly residents. Despite the need for prompt diagnoses, which are essential to implement all isolation measures necessary to contain the infection spread, deceased subjects in long-term care facilities are still are often diagnosed post-mortem. In this context, our study focuses on the use of post-mortem computed tomography for the diagnosis of COVID-19 infection, in conjunction with post-mortem swabs. The aim of this study was to assess the usefulness of post-mortem whole CT-scanning in identifying COVID-19 pneumonia as a cause of death, by comparing chest CT-findings of confirmed COVID-19 fatalities to control cases. Materials and methods The study included 24 deceased subjects: 13 subjects coming from long-term care facility and 11 subjects died at home. Whole body CT scans were performed within 48 h from death in all subjects to evaluate the presence and distribution of pulmonary abnormalities typical of COVID-19-pneumonia, including: ground-glass opacities (GGO), consolidation, and pleural effusion to confirm the post-mortem diagnosis. Results Whole-body CT scans was feasible and allowed a complete diagnosis in all subjects. In 9 (69%) of the 13 cases from long-term care facility the cause of death was severe COVID 19 pneumonia, while GGO were present in 100% of the study population. Conclusion In the context of rapidly escalating COVID-19 outbreaks, given that laboratory tests for the novel coronavirus is time-consuming and can be falsely negative, the post-mortem CT can be considered as a reliable and safe modality to confirm COVID-19 pneumonia. This is especially true for specific postmortem chest CT-findings that are rather characteristic of COVID-19 fatalities.

Deaths due to meningiomas are routinely diagnosed in clinical practice because this neoplasm tends to present with the typical progression of neurological deficits. On the other hand, sudden unexpected deaths due to meningiomas are rarely described in the literature. The study presents six fatal cases of previously undiagnosed intracranial meningiomas from the Cook County Medical Examiner's Office from 1998 to 2014. The most common explanation of the mechanism of sudden death due to intracranial neoplasms is a rapid increase in intracranial pressure produced by the mass effect of the neoplasm. Other mechanisms of death include acute intracranial and intratumoral hemorrhage, and benign neoplasms that grow in the vicinity of vital centers altering neural discharge in autonomic pathways leading to cardiac suppression or lethal arrhythmia. Forensic pathologists must keep in mind that sudden unexpected death caused by intracranial meningiomas, although extremely rare, may be encountered in the forensic setting.

Acute respiratory distress syndrome (ARDS) survivors experience a high prevalence of cognitive impairment with concomitantly impaired functional status and quality of life, often persisting months after hospital discharge. In this review, we explore the pathophysiological mechanisms underlying cognitive impairment following ARDS, the interrelations between mechanisms and risk factors, and interventions that may mitigate the risk of cognitive impairment. Risk factors for cognitive decline following ARDS include pre-existing cognitive impairment, neurological injury, delirium, mechanical ventilation, prolonged exposure to sedating medications, sepsis, systemic inflammation, and environmental factors in the intensive care unit, which can co-occur synergistically in various combinations. Detection and characterization of pre-existing cognitive impairment imparts challenges in clinical management and longitudinal outcome study enrollment. Patients with brain injury who experience ARDS constitute a distinct population with a particular combination of risk factors and pathophysiological mechanisms: considerations raised by brain injury include neurogenic pulmonary edema, differences in sympathetic activation and cholinergic transmission, effects of positive end-expiratory pressure on cerebral microcirculation and intracranial pressure, and sensitivity to vasopressor use and volume status. The blood-brain barrier represents a physiological interface at which multiple mechanisms of cognitive impairment interact, as acute blood-brain barrier weakening from mechanical ventilation and systemic inflammation can compound existing chronic blood-brain barrier dysfunction from Alzheimer’s-type pathophysiology, rendering the brain vulnerable to both amyloid-beta accumulation and cytokine-mediated hippocampal damage. Although some contributory elements, such as the presenting brain injury or pre-existing cognitive impairment, may be irreversible, interventions such as minimizing mechanical ventilation tidal volume, minimizing duration of exposure to sedating medications, maintaining hemodynamic stability, optimizing fluid balance, and implementing bundles to enhance patient care help dramatically to reduce duration of delirium and may help prevent acquisition of long-term cognitive impairment.

To prospectively evaluate the accuracy of ultrasound in defining the specific nature of superficial soft tissue masses as well as determining malignancy. Eight hundred twenty-three superficial soft tissue masses were prospectively evaluated with ultrasound by one of five experienced musculoskeletal radiologists. The radiologist at the time of examination provided one to three specific differential diagnoses and the perceived level of confidence with regard to each diagnosis. Clinical and ultrasound diagnoses were compared with the histological diagnosis to determine accuracy. Tumor malignancy was determined by histology or clinical/imaging follow-up. Histological correlation was present for 219 (26.6%) of the 823 masses. Compared with histology, the accuracy of clinical and ultrasound examination for determining specific tumor type was 25.6% and 81.2% respectively considering all differential diagnoses provided. Radiologists were “fully confident” with the ultrasound diagnosis in 585 (71.1%) of 823 masses overall. In this setting, when compared with histology, the diagnostic accuracy of ultrasound was 95.5%. When the radiologist was “not fully confident,” accuracy was 41.3% for the first differential diagnosis and 60.9% for all differential diagnoses. Diagnostic accuracy improved with increasing radiologist experience. Sensitivity, specificity, positive predictive value, and negative predictive value of ultrasound for identifying malignant tumor were 93.3%, 97.9%, 45.2%, and 99.9% respectively. One can be “fully confident” at characterizing over two-thirds of superficial soft tissue masses based on ultrasound appearances and, in this setting, diagnostic accuracy is very high. Ultrasound examination is also highly accurate at discriminating benign from malignant superficial soft tissue masses.

BackgroundMycoplasma genitaliumis increasingly seen as an emerging sexually transmitted pathogen, and has been likened toChlamydia trachomatis, but its natural history is poorly understood. The objectives of this systematic review were to determineM. genitaliumincidence, persistence, concordance between sexual partners, and the risk of pelvic inflammatory disease (PID).MethodsWe searched Medline, EMBASE, LILACS, IndMed and African Index Medicus from 1 January 1981 until 17 March 2018. Two independent researchers screened studies for inclusion and extracted data. We examined results in forest plots, assessed heterogeneity and conducted meta-analysis where appropriate. Risk of bias was assessed for all studies.ResultsWe screened 4634 records and included 17 studies; five (4100 women) reported on incidence, five (636 women) on persistence, 10 (1346 women and men) on concordance and three (5139 women) on PID. Incidence in women in two very highly developed countries was 1.07 per 100 person-years (95% CI, 0.61 to 1.53, I2 0%). Median persistence ofM. genitaliumwas estimated from one to three months in four studies but 15 months in one study. In ten studies measuringM. genitaliuminfection status in couples, 39-50% of male or female sexual partners of infected participants also hadM. genitaliumdetected. In prospective studies, the incidence of PID was higher in women withM. genitaliumthan those without (RR 1.68, 95% CI 0.59 to 2.77, I20%, 2 studies).DiscussionBased on findings from this and our linked review of prevalence, concordantM. genitaliummight be less common than forC. trachomatisand the age distributions of the infections differ. The synthesised data about prevalence, incidence and persistence ofM. genitaliuminfection are inconsistent. Taken together with evidence about antimicrobial resistance in the two infections,M. genitaliumis not the new chlamydia.Registration NumbersPROSPERO: CRD42015020420, CRD42015020405KEY MESSAGESThere are calls for widespread screening forMycoplasma genitalium, but the natural history of this emerging sexually transmitted pathogen is poorly understood.M. genitaliumincidence was 1.07 (95% confidence intervals, CI 0.61 to 1.53) per 100-person years in women in highly developed countries, 39-50% of infected individuals had a heterosexual partner withM. genitaliumand the risk ratio for pelvic inflammatory disease was 1.68 (95% CI 0.59 to 2.77).The duration of untreatedM. genitaliuminfection is probably longer than persistent detection ofM. genitalium, as measured in most cohort studies, in which inadvertent treatment cannot be ruled out.The results of this systematic review and other evidence sources show important differences in the epidemiology and dynamics ofM. genitaliumandChlamydia trachomatisinfection.

Early increase of hepatic artery resistive index (HARI) is frequently observed after liver transplant (LTx).We aimed to investigate contributing factors and prognostic relevance of high HARI after LTx from deceased donor.We conducted a retrospective analysis of prospectively collected data from January 2017 and February 2019. According to the Duplex Doppler HARI values (3Among 81 LTx, 36 had a high HARI and 45 a normal HARI. Patients developing high HARI were older, exhibited lower platelet, hemoglobin, platelet count/spleen diameter ratio, higher serum creatinine, and a more pronounced spleen enlargement (median values 170 versus 120 mm). At multivariate analysis, PLT/spleen diameter ratio (OR 0.994, p 0.001) creatinine levels (OR 2.418, p = 0.029), and recipient age (OR 1.157, p = 0.004) significantly predicted the occurrence of high HARI. Patients with high or normal HARI had similar vascular complications, rejection rate and 90-day mortality. In most cases, HARI recovered to normal without any clinical effect.HARI rises in presence of several surrogate markers of portal hypertension. The increase is mostly transitory, and it may result from the hepatic artery spasm due to the high portal blood flow.

Objective: Evaluate the efficacy and safety of renal artery embolization (RAE) for iatrogenic renal vascular injuries (IRVI) management at Fondazione Policlinico Universitario "A. Gemelli" IRCCS, in the last 5 years. Methods: Retrospective analysis of all RAE procedures performed from January 2013 to December 2017. Patients-related (age, sex, vascular variants, hemoglobin and serum creatinine), IRVI-related (type and vascular level of IRVI, presence and extension of hematoma), management-related (temporal interval between diagnostic imaging and RAE) and procedure-related (embolic materials, technical success, clinical success and complications) parameters were evaluated. Results: 28 RAE procedures performed on 28 patients (21 males; 7 females) were included. 19/28 patients had pseudoaneurysm, 7/28 active bleeding and 1/28 arteriovenous fistula; 4/28 patients had a combination of 2 IRVI. The extent of perirenal hematoma showed correlation with the cause of IRVI (p = 0.028). Technical success was achieved in all patients whereas clinical success in 25/28 (89.3%), with 3 patients requiring re-treatment. Minor complications were observed during 2/28 (7.1%) endovascular procedures. No major complications occurred. A longer procedural time was observed in patients with lower pre-procedural levels of hemoglobin (p = 0.016). No differences were found in mean serum creatinine (p = 0.23) before and immediately after treatment, while values of creatinine at 1 week from the procedure were significantly lower (p = 0.04). Conclusion: RAE is safe and effective for the management of iatrogenic IRVI showing high technical and clinical success rate and low complication rate. Advances in knowledge: Low pre-procedural hemoglobin levels increase procedural duration time. Glue alone or in combination with other materials is as safe as coils.

The deep inferior epigastric perforator (DIEP) flap is used with increasing frequency in post-mastectomy breast reconstruction. Preoperative mapping with CT angiography (CTa) is crucial in reducing surgical complications and optimizing surgical techniques. Our study’s goal was to investigate the accuracy of conventional CT (cCT), performed during disease staging, compared to CTa in preoperative DIEP flap planning. In this retrospective, single-center study, we enrolled patients scheduled for mastectomy and DIEP flap breast reconstruction, subjected to cCT within 24 months after CTa. We included 35 patients in the study. cCT accuracy was 95% (CI 0.80–0.98) in assessing the three largest perforators, 100% (CI 0.89–100) in assessing the dominant perforator, 93% (CI 0.71–0.94) in assessing the perforator intramuscular course, and 90.6% (CI 0.79–0.98) in assessing superficial venous communications. Superficial inferior epigastric artery (SIEA) caliber was recognized in 90% of cases (CI 0.84–0.99), with an excellent assessment of superficial inferior epigastric vein (SIEV) integrity (96% of cases, CI 0.84–0.99), and a lower accuracy in the evaluation of deep inferior epigastric artery (DIEA) branching type (85% of cases, CI 0.69–0.93). The mean X-ray dose spared would have been 788 ± 255 mGy/cm. Our study shows that cCT is as accurate as CTa in DIEP flap surgery planning.

Background The implementation of multidisciplinary tumor board (MDTB) meetings significantly ameliorated the management of oncological diseases. However, few evidences are currently present on their impact on pancreatic cancer (PC) management. The aim of this study was to evaluate the impact of the MDTB on PC diagnosis, resectability and tumor response to oncological treatment compared with indications before discussion. Patients and methods All patients with a suspected or proven diagnosis of PC presented at the MDTB from 2017 to 2019 were included in the study. Changes of diagnosis, resectability and tumor response to oncological/radiation treatment between pre- and post-MDTB discussion were analyzed. Results A total of 438 cases were included in the study: 249 (56.8%) were presented as new diagnoses, 148 (33.8%) for resectability assessment and 41 (9.4%) for tumor response evaluation to oncological treatment. MDTB discussion led to a change in diagnosis in 54/249 cases (21.7%), with a consequent treatment strategy variation in 36 cases (14.5%). Change in resectability was documented in 44/148 cases (29.7%), with the highest discrepancy for borderline lesions. The treatment strategy was thus modified in 27 patients (18.2%). The MDTB brought a modification in the tumor response assessment in 6/41 cases (14.6%), with a consequent protocol modification in four (9.8%) cases. Conclusions MDTB discussion significantly impacts on PC management, especially in high-volume centers, with consistent variations in terms of diagnosis, resectability and tumor response assessment compared with indications before discussion., Highlights • Few evidences are present on the impact of the multidisciplinary tumor board (MDTB) on pancreatic cancer (PC) management • We documented a discrepancy rate of 23.7% between the pre- and post-MDTB discussion. • This underlines the fundamental role of the MDTB in PC management.

The Hard-Soft Acid and Base hypothesis can be used to predict the potential bio-reactivity (electrophilicity) of a chemical with intracellular proteins, resulting in neurotoxicity. Twelve chemicals predicted to be neurotoxic were evaluated in vitro in rat dorsal root ganglia (DRG) for effects on cytotoxicity (%LDH), neuronal structure (total neurite length/neuron, NLPN), and neurophysiology (mean firing rate, MFR). DRGs were treated acutely on days in vitro (DIV) 7 (1–100 μM) with test chemical; %LDH and NLPN were measured after 48 h. 4-cyclohexylhexanone (4-C) increased %LDH release at 50 (29%) and 100 μM (56%), citronellal (Cit) and 1-bromopropane increased %LDH at 100 μM (22% and 26%). 4-C, Cit, 2,5 Hexanedione (2,5Hex), phenylacetylaldehyde (PAA) and 2-ethylhexanal decreased mean NLPN at 48 h; 50 and 100 μM for 4-C (28% and 60%), 100 μM Cit (52%), 100 μM 2,5- Hex (37%) 100 μM PAA (41%) and 100 μM for 2-ethylhexanal (23%). Separate DRG cultures were treated on DIV 14 and changes in MFR measured. Four compounds decreased MFR at 50 or 100 μM: Acrylamide (−83%), 3,4-dichloro-1-butene (−93%), 4-C (−89%) and hexane (−79%, 50 μM). Changes in MFR and NLPN occurred in absence of cytotoxicity. While the current study showed little cytotoxicity, it gave insight to initial changes in MFR. Results provide insight for future chronic exposure experiments to evaluate neurotoxicity.

Iron-deficiency anemia is a growing concern and administration of oral iron may be affected by proton pump inhibitors. This drug interaction is common and often overlooked. Iron absorption requires an acidic environment that may be lowered by concomitant use of proton pump inhibitors. Administration of acidic agents, such as vitamin C or orange juice, along with oral iron, may help improve absorption, avoid the use of acid suppression medications, or provide more oral iron availability in those with iron-deficiency anemia. Nurse practitioners are primary health care providers who can help recognize this common drug interaction and help to improve patient care.

151 Background: Decision aids (DAs) for prostate cancer treatment can improve knowledge and reduce decisional conflict, but the relative effect of pre-visit and within-visit DAs is not known, and effect sizes for minority populations has not been estimated. Methods: We conducted a 3-arm, patient-level-RCT in specialty urology and radiation oncology practices in Ohio, South Dakota, and Alaska, test the effect of pre-consultation and with-in consultation decision aids on patient knowledge immediately after specialty consultation compared to usual care. We used linear regression to estimate effects of each intervention arm, including the respective standard error, two-sided 95% confidence interval, and two-sided P value for testing the study’s hypotheses. Results: 103 patients were recruited and randomized to receive either the pre-visit decision aid, within-visit decision aid, or neither decision aids (usual care). In 2017 and 20018, we accrued similar numbers of men to pre-consultation aid (n = 37), during-consultation aid (n = 33) and usual care arms, respectively (n = 33). The median (range) age in years was 64 [49, 81]; 67.6% were White, 15.7% were Black or African American, 16.7% were American Indian or Alaska Native, and 1% were not reported. 47.6%, 45.6%, and 6.8% had a baseline clinical stage of T1, T2, and T3, respectively. The median [range] prostate specific antigen (PSA) was 8.0 [2.4, 53.7]. There were no clinically notable imbalances. We obtained usable data on 102 of the 103 patient-participants. The pre-visit decision aid arm showed a mean knowledge effect of 0.694 (0.636, 0.753). The within-visit decision arm showed a very similar mean knowledge effect of 0.686 (0.625, 0.748). The usual care arm showed a mean knowledge effect of 0.644 (0.582,0.705). The linear regression model showed, that, compared with usual care, neither intervention effect achieved statistical significance in the primary analysis (p = 0.24, 0.330, for pre-visit and within-visit, respectively). Conclusions: Modest knowledge gains of pre-visit and during-visit decision aids for prostate cancer treatment were not statistically significant. Clinical trial information: NCT03182998 .

Pancreatic cancer is the third most common cause of death from cancer in the US. The disease has a poor prognosis with a five-year survival rate under 10%. Mutations in KRAS are driving tumor growth in about 95% of patients with pancreatic cancer. Currently there are no approved drugs that target KRAS. Recently there has been progress targeting a specific mutation, KRAS G12C with small molecules in lung cancer, but this mutation accounts for only 1% of patients with Pancreatic Ductal Adenocarcinoma (PDAC). RNA interference has the potential to directly target KRAS, but delivery to pancreas has been challenging. We have developed a lipid nanoparticle formulation that is able to distribute to pancreatic tumor tissue. The proprietary lipid nanoparticle (LNP) is comprised of an ionizable, non-immunogenic, biodegradable lipid and the composition has been tuned to favor enrichment in pancreatic tumor by screening in orthotopic pancreatic tumor mouse models. A potent siRNA with IC50 in the range of 10pM targeting KRAS directly has been identified and the activity on downstream pathways and kinetics have been demonstrated. Transfection of ND-05-1192 led to more impeded cell growth in pancreatic cancer cells (PANC-1, AsPC-1, Capan-1, SW1990 and BxPC-3) than normal cells (human hepatocyte, pancreatic cells and HUVEC cells). Western blot results demonstrated effective downregulations of key proteins involved in MAPK and PI3K signaling pathways and upregulated activities of proteins involved in apoptotic signaling pathways, such as BIM, caspase 3/7 and cleaved-PARP following inhibition of KRAS protein expression. In vivo biodistribution and tumor cell uptake study results demonstrated that LNP transported ND-05-1192 siRNA molecules to the pancreas site and pancreatic orthotopic tumor tissues with the majority of tumor cells showing LNP product uptake. The application of ND-05-1192/LNP product significantly suppressed tumor growth in PANC-1 and AsPC-1 bioluminescent orthotopic pancreatic xenograft models. Inhibition efficiency revealed by tumor weight and bioluminescent response (BLR) as the treatment end points reached up to 50% in the PANC-1 orthotopic xenografts following once weekly intravenous administration. In the orthotopic AsPC-1 model, the average BLR was significantly reduced in a dose-dependent manner. Additionally, in AsPC-1 orthotopic xenografts, the survival rate of the ND-05-1192/LNP treatment group was significantly prolonged at a 4 mg/kg dose compared to the vehicle control group. In summary, we conclude that ND-05-1192/LNP is delivered to the orthotopic pancreatic tumor and its considerable uptake by tumor cells results in KRAS target downregulation, tumor growth inhibition and overall survival benefit as demonstrated in our orthotopic xenograft models. Citation Format: Zhihong (Julie) OBrien, Li Wang, Cima Cina, Bharat Majeti, James Chu, Xiaoen Wang, Robiel Baclig, James Lin, Jose Ibarra, Dhrubamitra Chatterjee, Jung-Kang Jin, Jean-Pierre Clamme, Jennifer Daniels, Hai Wang, Jens Harborth, Wenbin Ying. Discovery and preclinical development of KRAS-targeting siRNA therapeutic modality for the treatment of pancreatic cancer [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 4060.

e19196 Background: The management of PD is very insidious, mainly due to the often difficult differential diagnosis between benign and malignant diseases, and, in case of pancreatic ductal adenocarcinoma (PDCA), to the frequently hard differentiation among resectable/borderline PDCA susceptible to upfront surgery, locally advanced PDCA susceptible to a neoadjuvant approach and never resectable or metastatic PDCA in which a palliative treatment is the only option. A correct PD evaluation and the subsequent choice of the most appropriate treatment strategy, thus, need a MA, involving surgeons, oncologists, radiologists, radiation oncologists, endoscopists, gastroenterologists and pathologists. On the basis of such considerations, we investigate the impact of the multidisciplinary meeting (MM) in the management of PD at our Institution. Methods: We retrospectively evaluated all the cases discussed by surgeons at our MM. We collected data, both pre- and post-MM, regarding diagnosis (cyst vs pancreatitis vs IPMN vs PDCA), and, in case of PDCA, tumor burden at baseline (resectable vs border-line resectable vs locally advanced vs metastatic disease) and disease response to treatment (disease control vs progression). Primary endpoint was the overall rate of discrepancy in diagnosis and/or PD evaluation between pre- and post-MM. Results: From October 2018 to December 2019, a total of 139 cases were presented by surgeons. After MM, a total of 38 diagnosis and/or PD evaluation were modified, for an overall discrepancy rate of 27%. In particular, of the 38 discordant cases, 9 (24%) were initial diagnosis, 24 (63%) baseline tumor burden assessments and 5 (13%) were PDCA response evaluations. Among the 24 cases of tumor burden evaluations, treatment strategy changed in 17 out of 24 cases. More specifically, of the 19 cases, evaluated as borderline/resectable before the MM, 15 were defined as locally-advanced or metastatic disease after the MM; of the 5 cases, evaluated as not resectable before the MM, 2 were considered border-line/resectable after the MM. Similarly, out of 9 cases of discrepant initial diagnosis, 5 cases, considered as malignant disease before MM, were assessed as benign after the MM. Conclusions: Our analysis demonstrates a significant rate of discrepancy in diagnosis and/or PD evaluation between pre- and post-MM. Our results show that a MA allows a considerable modification in PD diagnosis and evaluation, maximizing the treatment strategy, in particular avoiding unnecessary and detrimental pancreatic surgery.

Background Lung cancer is an important public health issue, particularly among American Indians (AIs). The reported decline in tobacco use for most racial/ethnic groups is not observed among AIs. This project was designed to address the research question, “Why don't more Northern Plains American Indians alter tobacco use behaviors known to increase the risk of cancer?” Methods Guided by the Theory of Planned Behavior, a multi-component intervention study was implemented. Adult AIs, age 18 years or older and currently smoking, were enrolled. Eligible subjects were randomized to one of 15 groups and exposed to either a MINIMAL or an INTENSE level of 4 intervention components. The intervention was delivered face-to-face or via telephone by Patient Navigators (PN). The primary outcome was self-reported abstinence from smoking verified by carbon monoxide measurement. Results At 18 months post-quit date, 88% of those who were still in the study were abstinent. This included 6% of all participants who enrolled in the study (14/254) and 13% of those who made it to the quit date (14/108). No intervention groups were found to have significant proportions of participants who were abstinent from smoking at the quit date (visit 5) or primary outcome visit (18 months post-quit date, visit 11), but use of pharmacologic support for abstinence was found to be an effective strategy for individuals who continued participation throughout the study. Those who remained in the study received more visits and were more likely to be abstinent. Conclusions Use of NRT increased the odds of not smoking, as assessed at the 18-month follow-up visit, but no other interventions were found to significantly contribute to abstinence from smoking. Although the intervention protocol included numerous points of contact between CRRs and participants (11 visits) loss to follow-up was extensive with only 16/254 remaining enrolled. Additional research is needed to improve understanding of factors that influence enrollment and retention in smoking cessation interventions for AI and other populations.

Rhabdomyolysis is a syndrome characterized by muscle necrosis that leads to release of the intracellular contents of muscle cells into the systemic circulation. Rhabdomyolysis due to overexertion is an uncommon but well-known severe complication of strenuous activity. Exertional rhabdomyolysis (ER) is typically described in weight lifters and military recruits undergoing basic training. Few cases have been reported in football players without known predisposing risk factors. We report our experience with this condition in college football players in a single institution.College football players hospitalized for heat illness complicated by rhabdomyolysis were identified over a 23-year period. Clinical and laboratory findings were collected. Clinical course was recorded.Twelve patients were identified. All were Black males. One had sickle cell trait. BMI averaged 33 kg/mER is a serious complication of strenuous physical activity that can threaten renal function. ER tends to occur in August, which coincides with the start of football practice when athletes are more likely to be detrained. The condition can occur in Black athletes in the absence of sickle cell trait. ER carries a good prognosis when recognized early and treated adequately.

Objectives Opioid misuse has reached epidemic proportions in the United States. Post-operative opioids have been linked to overdose, diversion, and dependency in adults, but comparatively less is known in children. We evaluated opioid prescriptions following tonsillectomy and hernia repair at our institution. Methods Retrospective chart review of all outpatient tonsillectomies and inguinal/umbilical hernia repairs at a single institution. Data on opioid and non-opioid analgesic prescription characteristics and post-operative pain control were reviewed. Results 470 procedures were reviewed (276 tonsillectomy, 194 hernia repair). In patients with an indication (> 5 years-old in tonsillectomy, > 1 year-old in hernia repair), 85.0% and 85.6% received a post-op opioid prescription, respectively. Mean days' opioid supplied was 6.19 +/− 4.39 days in tonsillectomy and 4.30 +/− 2.94 days for hernia repair. There was significant inter- and intra-provider variation in the days' supplied of post-operative opioid. 90–100% of patients reported adequate pain control at discharge callback regardless of pain control regimen (opioid alone, opioid + non-opioid analgesic, non-opioid analgesic alone). Conclusions Significant variation in post-operative prescribing practices was identified as well as overall over-prescription, which will serve as a starting point to institute evidence-based intervention to reduce post-operative opioid misuse after these common pediatric surgical procedures. Level of Evidence IV

BACKGROUND: Fresh frozen plasma (FFP) is widely used in critically ill patients to correct the deficiency of coagulation factors or increased INR.AIM: In the present study we aimed to evaluate the outcome of the freshly frozen plasma use as prophylaxis in ICU patients before an invasive procedure.METHODS: The study was conducted at Central Anaesthesiology and Intensive Care Service UHCT “Mother Theresa”, Tirana. 136 patients were enrolled with coagulopathy with no bleeding before the invasive procedure, from June 2016 to December 2016. A group of 75 patients underwent a median volume of 12.5 ml/kg FFP given, and 61 had no transfusion. Data were collected on demographics, the severity of illness measured by APACHE III scores, INR, medication use, hemodynamic data.RESULTS: From 136 patients with coagulopathy with no bleeding who underwent planned invasive interventions, 75 [55%] received FFP, vs 61 [45%] p = 0.04 who did not receive. Overall, the median FFP dose was 12.5 ml kg-1. Median INR level in FFP and non-FFP groups was respectively 3.1 (1.9-4.8) and 3.5 (1.8-5.2). INR was corrected in 24 of 75 (32%) of those who received a transfusion. The frequency of minor bleeding episodes was 9.3% in transfused patients vs 4.9% in the non-transfused group. Patients who developed an onset of acute lung injury were more frequent in the FFP group. No allergic transfusion complications were observed. Also, the median length of hospital stay [LOS] was 3.05 days vs 2.91 days and mortality rate 8.2% vs 6.5% with no significant difference between two groups.CONCLUSIONS: Freshly frozen plasma transfusions are often unnecessarily administered during an inadequate correction of the deficiencies of coagulation factors. When comparing a liberal FFP transfusion strategy vs restrictive other clinical trials are required to asses which one is the best to adopt in intensive care settings.