Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT).

BACKGROUND: Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy. OBJECTIVE: With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in health care. METHODS: LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcome data. The primary objectives include performance assessment through the establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population. RESULTS: The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028. CONCLUSIONS: LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation of outcomes and care processes, guiding clinicians and policymakers in optimizing patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis on holistic cancer care. Insights gained from this study may influence treatment strategies, resource utilization, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management. TRIAL REGISTRATION: ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/57183.

Effect of extending the period from oral administration of 5-aminolevulinic acid hydrochloride to photodynamic diagnosis during transurethral resection for non-muscle invasive bladder cancer on diagnostic accuracy and safety: a single-arm multicenter phase III trial.

BACKGROUND: In Japan, the authorized period (2-4 h) between oral administration of 5-aminolevulinic acid hydrochloride (5-ALA) and transurethral resection for non-muscle invasive bladder cancer (NMIBC) may restrict photodynamic diagnosis (PDD) usage. Therefore, this prospective, single-arm, phase III study aimed to evaluate the diagnostic accuracy and safety of PDD at an extended administration period (4-8 h). METHODS: From January 2022 to May 2023, 161 patients with NMIBC were enrolled from eight hospitals. The primary endpoint was the blue light (BL) sensitivity of pathologically positive biopsies. The secondary endpoints were a comparison of the specificity and positive and negative prediction rates under BL and white light (WL) conditions. RESULTS: A total of 1242 specimens comprising 337 histological NMIBC specimens were analyzed. BL-sensitivity was 95.3%. Its lower limit of 95% confidence interval (92.4-97.3%) exceeded the threshold (70%) of non-inferiority to authorized usage. Sensitivity and specificity were significantly higher and lower for BL than those for WL (95.3% vs. 61.1%, P < 0.001; 52.7% vs. 95.2%, P < 0.001), respectively. The positive and negative predictive rates were significantly lower and higher for BL than those for WL (42.9% vs. 82.7%, P < 0.001; 96.8% vs. 86.8%, P < 0.001), respectively. Of the 145 patients receiving 5-ALA, 136 (93.8%) and 75 (51.7%) experienced 377 adverse events and 95 adverse reactions, respectively, most of which were grade 1 or 2. CONCLUSION: For extended period, the efficacy of PDD for NMIBC was similar to that of authorized period, in terms of higher sensitivity and lower specificity compared with WL, and the safety was acceptable.

Development and Validation of a Computed Tomography-Based Model for Noninvasive Prediction of the T Stage in Gastric Cancer: Multicenter Retrospective Study.

BACKGROUND: As part of the TNM (tumor-node-metastasis) staging system, T staging based on tumor depth is crucial for developing treatment plans. Previous studies have constructed a deep learning model based on computed tomographic (CT) radiomic signatures to predict the number of lymph node metastases and survival in patients with resected gastric cancer (GC). However, few studies have reported the combination of deep learning and radiomics in predicting T staging in GC. OBJECTIVE: This study aimed to develop a CT-based model for automatic prediction of the T stage of GC via radiomics and deep learning. METHODS: A total of 771 GC patients from 3 centers were retrospectively enrolled and divided into training, validation, and testing cohorts. Patients with GC were classified into mild (stage T1 and T2), moderate (stage T3), and severe (stage T4) groups. Three predictive models based on the labeled CT images were constructed using the radiomics features (radiomics model), deep features (deep learning model), and a combination of both (hybrid model). RESULTS: The overall classification accuracy of the radiomics model was 64.3% in the internal testing data set. The deep learning model and hybrid model showed better performance than the radiomics model, with overall classification accuracies of 75.7% (P=.04) and 81.4% (P=.001), respectively. On the subtasks of binary classification of tumor severity, the areas under the curve of the radiomics, deep learning, and hybrid models were 0.875, 0.866, and 0.886 in the internal testing data set and 0.820, 0.818, and 0.972 in the external testing data set, respectively, for differentiating mild (stage T1~T2) from nonmild (stage T3~T4) patients, and were 0.815, 0.892, and 0.894 in the internal testing data set and 0.685, 0.808, and 0.897 in the external testing data set, respectively, for differentiating nonsevere (stage T1~T3) from severe (stage T4) patients. CONCLUSIONS: The hybrid model integrating radiomics features and deep features showed favorable performance in diagnosing the pathological stage of GC.

Optimal results through enhanced recovery: Achieving textbook outcomes with high compliance in elective liver surgery.

BACKGROUND: Existing studies suggest a positive correlation between high compliance with enhanced recovery programs (ERP) and improved outcomes. While individual outcome measures have advantages, composite benchmarks, such as textbook outcome (TO), offer a more comprehensive assessment of healthcare performance. Given the link between ERP and postoperative outcomes, this study aims to investigate the impact of ERP on TO attainment after liver surgery (LS). METHODS: A prospective multicenter cohort of patients undergoing LS and exposed to ERP from 2016 to 2022 in France was analyzed. The primary outcome was to compare the rates of TO achieved between patients with high ERP compliance (>70%) and those with low ERP compliance (<70%) after LS. RESULTS: A total of 706 patients were included in the study, and 217 (30.7%) achieved TO: 170 patients with high ERP compliance (24%) versus 47 patients (6.6%) with low ERP compliance attained TO (p < 0.001). High ERP compliance was associated to an increased likelihood of achieving TO [odds ratio (OR) = 1.49 (95% CI: 1.01, 2.24); p = 0.049], while cholangiocarcinoma [OR = 0.11 (95% CI: 0.02, 0.39); p = 0.003], high complexity LS [OR = 0.22 (95% CI: 0.13, 0.36); p < 0.001], intraoperative hypotension requiring vasopressors [OR = 0.29 (95% CI: 0.10, 0.68); p = 0.010], and post-operative ileus [OR = 0.08 (95% CI: 0.00, 0.37); p = 0.013] were negatively associated to the likelihood of achieving TO. CONCLUSIONS: Patients with high ERP compliance after LS experience elevated rates of TO, compared to those with low ERP compliance.

Parathyroid carcinoma and atypical parathyroid tumor: analysis of an Italian database.

OBJECTIVE: Atypical parathyroid tumor (aPT) and parathyroid carcinoma (PC) are extremely rare parathyroid neoplasms, accounting together for <2% of all parathyroid tumors. They often present an overlapping clinical phenotype, sharing clinical, biochemical, and some histological features. They are distinguished only by the presence of local invasion, and lymph nodes or distant metastasis, which are all absent in aPTs. To date, only few studies have compared clinical presentation and features between aPTs and PCs. Our purpose was to conduct a retrospective study on a multicenter Italian database of aPT and PC patients. DESIGN AND METHODS: We comparatively analyzed main features of aPT (n = 57) and PC (n = 74) patients collected at 15 major endocrinology and endocrine surgery centers in Italy. RESULTS AND CONCLUSIONS: Atypical parathyroid tumors and PCs showed no significant differences in many clinical features and presented similar values of elevated parathyroid hormone and total serum calcium. Renal complications, namely nephrolithiasis and nephrocalcinosis, appeared to be more common in PC, with a significantly higher rate of renal colic, regardless of total serum calcium levels and 24-h calciuria. Parathyroid carcinomas showed significantly higher postoperative disease persistence and recurrence rates, presumably due to an uncomplete resection of the primary tumor in 23.5% of cases and/or presence of unremoved active metastasis, but they had similar disease-free mean time after surgery than aPT. To deepen the study of malignant parathyroid tumors, the institution of a novel Italian retro-prospective multicenter registry of aPTs and PCs is currently ongoing, and a dedicated PC European registry has been recently activated.

Bicanalicular stent versus mono-canalicular stent for post-oncological lacrimal duct reconstruction: A retrospective cohort study.

BACKGROUND: Bicanalicular and mono-canalicular stent intubations were developed for post-oncological lacrimal duct reconstruction; however, comparative analysis between the two surgical modalities is lacking. This study aimed to compare the surgical outcomes between the two types of stents at a single institution. MATERIALS AND METHODS: Briefly, 75 eyes of 75 patients who underwent lacrimal reconstruction combined with lacrimal stent intubation were enrolled in this study and were divided into bicanalicular stent intubation and mono-canalicular stent intubation groups. The clinical characteristics, follow-up, and prognosis were compared between the two groups. RESULTS: Bicanalicular and mono-canalicular stent intubations were performed in 36 eyes (36 patients; Group A) and 39 eyes (39 patients; Group B), respectively. The difference in stent duration between Groups A and B was statistically significant. Three eyes in Group A and one eye in Group B experienced postoperative stent prolapse. Two eyes in Group B showed punctum stenosis and one eye had punctal ectropion. Seven eyes in Group A had canalicular slitting. There were no statistically significant differences in the mean preoperative Munk scores between the two groups. There were no statistically significant differences in the mean Munk scores and mean VAS scores at 1 week postoperatively, before stent removal, and 3 months after stent removal between the two groups. CONCLUSION: Bicanalicular and mono-canalicular stent intubations were equally effective in ensuring lacrimal duct patency and in preventing postoperative epiphora. Appropriate cases and stent selection can reduce the incidence of postoperative complications.

Improvement of survival outcomes of cholangiocarcinoma by ultrasonography surveillance: Multicenter retrospective cohorts.

Background: Most cholangiocarcinoma (CCA) patients present with late stage of disease because of the difficulty to diagnosis at an early stage, resulting in poor survival of CCA patients. The Cholangiocarcinoma Screening and Care Program showed that ultrasound screening was an effective tool for detecting early stage CCA. This study aims to evaluate the survival outcome of patients diagnosed by ultrasound screening (US) compared to walk-in symptomatic patients. Methods: The retrospective clinical data and medical records for this study were accessed in June 30, 2021. 5-year survival rates (5-YSR) and median survival time (MST) of CCA were calculated using the Kaplan-Meier method. Multivariate analyses were performed for significant factors from univariate analyses. Results: A total of 711 histologically proven CCA cases were examined including ultrasound screening and walk-in groups. The screening group having 5-YSR was 53.9 %, and MST was of 67.2 months, while walk-in group, the 5-YSR was 21.9 % and MST was 15.6 months (p < 0.001). In addition, multivariate analyses revealed that screening program was an independent factor to predict a good outcome of CCA patients when compared with walk-in group (p = 0.014). Conclusion: US is an effective tool for detecting early stage CCA leading to improve clinical outcome of CCA patients. Practically, US should be considered as a first tool for screening CCA in risk populations.

Dedifferentiated liposarcoma of the extremities: a Korean multi-center study of 107 cases.

BACKGROUND: Dedifferentiated liposarcoma of the extremities (DDL-E) is rare in comparison to that of the retroperitoneum. Its clinical features and surgical principle for resection margins at the dedifferentiated and the well-differentiated components are yet to be elucidated. METHODS: This retrospective multi-center study examined patients diagnosed with DDL-E from August 2004 to May 2023 at 5 sarcoma centers. Clinical features, oncologic outcomes, and prognostic factors were analyzed. RESULTS: A total of 107 patients were reviewed. The 5-year local recurrence free survival (LRFS), metastasis-free survival (MFS) and disease specific survival (DSS) were 84.7%, 78.6%, and 87.8%, respectively. Other primary malignancies and extrapulmonary metastasis were observed in 27 and 4 patients, respectively. The independent risk factor for local recurrence was R1/2 margin at the dedifferentiated component of the tumor. Metastasis was associated with tumor size in univariate analysis. The independent risk factor for DSS was tumor grade. Previous unplanned excision, de novo presentation, tumor depth, absence of the well-differentiated component, infiltrative border, R1/2 margin at the well-differentiated component were not associated with oncologic outcomes. CONCLUSIONS: This is the largest study examining DDL-E to-date. Localized DDL-E has low potential for metastasis and carries an excellent prognosis. Other primary malignancy and extrapulmonary metastasis are more frequent in DDL-E, thus close monitoring of other sites during follow-up is recommended. While wide resection margin is the standard surgical approach for DDL-E, further investigation into moderated wide resection margin at the well-differentiated component is warranted.

Development of a predictive model for patients with bone metastases referred to palliative radiotherapy: Secondary analysis of a multicenter study (the PRAIS trial).

BACKGROUND: The decision to administer palliative radiotherapy (RT) to patients with bone metastases (BMs), as well as the selection of treatment protocols (dose, fractionation), requires an accurate assessment of survival expectancy. In this study, we aimed to develop three predictive models (PMs) to estimate short-, intermediate-, and long-term overall survival (OS) for patients in this clinical setting. MATERIALS AND METHODS: This study constitutes a sub-analysis of the PRAIS trial, a longitudinal observational study collecting data from patients referred to participating centers to receive palliative RT for cancer-induced bone pain. Our analysis encompassed 567 patients from the PRAIS trial database. The primary objectives were to ascertain the correlation between clinical and laboratory parameters with the OS rates at three distinct time points (short: 3 weeks; intermediate: 24 weeks; prolonged: 52 weeks) and to construct PMs for prognosis. We employed machine learning techniques, comprising the following steps: (i) identification of reliable prognostic variables and training; (ii) validation and testing of the model using the selected variables. The selection of variables was accomplished using the LASSO method (Least Absolute Shrinkage and Selection Operator). The model performance was assessed using receiver operator characteristic curves (ROC) and the area under the curve (AUC). RESULTS: Our analysis demonstrated a significant impact of clinical parameters (primary tumor site, presence of non-bone metastases, steroids and opioid intake, food intake, and body mass index) and laboratory parameters (interleukin 8 [IL-8], chloride levels, C-reactive protein, white blood cell count, and lymphocyte count) on OS. Notably, different factors were associated with the different times for OS with only IL-8 included both in the PMs for short- and long-term OS. The AUC values for ROC curves for 3-week, 24-week, and 52-week OS were 0.901, 0.767, and 0.806, respectively. CONCLUSIONS: We successfully developed three PMs for OS based on easily accessible clinical and laboratory parameters for patients referred to palliative RT for painful BMs. While our findings are promising, it is important to recognize that this was an exploratory trial. The implementation of these tools into clinical practice warrants further investigation and confirmation through subsequent studies with separate databases.

Transoral laser microsurgery for supraglottic carcinomas: results of a prospective multicenter trial (SUPRATOL).

Background: A limited number of single institutions have published retrospective cohort studies on transoral laser microsurgery for supraglottic laryngectomy (TLM-SGL). These studies have shown that the oncologic outcomes of TLM-SGL are comparable to those of open SGL. However, there is limited information available regarding swallowing rehabilitation and quality of life (QoL). Patients and methods: SUPRATOL is a prospective, multicenter trial assessing the functional outcomes of TLM-SGL +/- adjuvant radio-(chemo)-therapy. The primary endpoint was aspiration-free swallowing at 12 months, as established using fibreoptic endoscopic evaluation of swallowing (FEES) and defined as a grade < 6 on the penetration-aspiration scale. Secondary endpoints were swallowing- and voice-related QoL, the prevalence of temporary and permanent tracheostomy and percutaneous gastrostomy, local control, laryngectomy-free survival, overall survival, and disease-free survival, as well as the influence of treatment centers on outcomes. Results: From April 2015 to February 2018, 102 patients were recruited from 26 German Otorhinolaryngology (ORL) hospitals. All patients had TLM-SGL and 96.1% underwent uni- or bilateral, mostly selective neck dissection. To 47.0% of patients, adjuvant radio-(chemo)-therapy (R(C)T) was administered. The median follow-up period was 24.1 months. At 12-month follow-up, completed by 84.3% of patients, 98.2%, 95.5%, and 98.8% were free of aspiration when tested with saliva, liquid, or pulp. Adjuvant R(C)T, pT category, and type of resection had no significant influence on swallowing rehabilitation. A total of 40.2% of patients had been tracheotomized, and in 46.1% of patients, a PEG tube was inserted. At the 24-month follow-up, 5.3% of patients still required a tracheostomy, and 8.0% continued to use a percutaneous endoscopic gastrostomy (PEG) tube. Deterioration of swallowing- and voice-related QoL was observed immediately after treatment, but patients recovered, and baseline values were reached again. The Kaplan-Meier 2-year rates for local control, laryngectomy-free survival, overall survival, and disease-free survival were 88%, 92%, 93%, and 82%, respectively. Conclusions: Our prospective multicenter trial shows that, at 12 months post-TLM-SGL +/- R(C)T, 95.5%-98.8% of patients achieved aspiration-free swallowing. Morbidity was higher than previously reported. The rates of permanent tracheostomy and gastrostomy tube placement correspond to previous cohort studies. The 2-year oncologic outcomes are within the reported range. Clinical trial registration: https://drks.de/search/en/trial/DRKS00004641, identifier (DRKS00004641).

Computed Tomography Findings of Patients Presenting With Headache: 4-Year Retrospective Two-Center Study in Central and Western Regions of Ghana.

Objectives: The radiographic assessment of the head is a crucial part of headache care. A computed tomography (CT) scan enables a more detailed analysis of the condition and more focused care. This study examined head CT scans to determine what kinds of anomalies were present in patients with headaches as their primary complaint. Methods: We evaluated 4 years' worth of CT scan data from head exams conducted at two diagnostic facilities in Ghana's western and central regions. We examined data on 477 patients with a headache as their primary complaint between January 2017 and December 2020. We employed chi-square and Fisher's exact tests (where applicable) to compare head CT diagnoses between age groups, gender, headache subtypes, and brain lesion subgroups. Results: There were 53.5% (n = 255) females and 46.5% (n = 222) males in the study. The average age of patients was 38.67 ± 17.23 years, with an annual rate of abnormal CT diagnoses ranging from 35.9% in 2017 to 45.4% in 2022. Abnormal head CT diagnoses are strongly correlated with age groups and patient gender (p = 0.011 and p = 0.009, respectively). Of the 202 patients, 15.3% and 24.3% were classified as intracranial lesions and extracranial lesions, respectively. Maxillary sinusitis affected nearly 60% of the patients, while tumors and hemorrhages affected 25.2% and 11.9%, respectively. Conclusions: A CT scan of the head is essential to detect abnormalities in nearly 50% of patients suffering from various degrees of headache. Sinusitis, brain tumors, and hemorrhage were common lesions detected. It is crucial to create local standard operating procedures to promote better utilization of this type of imaging service, particularly among patients who have been diagnosed with headaches.

Efficacy of the da Vinci robot versus thoracoscopic surgery for patients with mediastinal tumors of different body mass index: a multicenter propensity score-matched study.

BACKGROUND: The purpose of the present study was to evaluate the efficacy and safety of da Vinci robot-assisted thoracoscopic surgery (RATS) versus video-assisted thoracoscopic surgery (VATS) for the treatment of patients with mediastinal tumors of different body mass indices (BMI). METHODS: A retrospective cohort study was used to collect 260 patients with mediastinal tumors admitted to three medical centers in China from December 2020 to March 2024. These patients underwent mediastinal tumor resection by RATS (n = 125) or VATS (n = 135). Propensity score matching (PSM) analysis was performed for the both groups, and further, the patients were divided into the N-BMI group (18.5 kg/m2 ≤ BMI < 25 kg/m2) and the H-BMI group (BMI ≥ 25 kg/m2) based on their BMI to compare patients' surgery-related information. RESULTS: The RATS group had more advantages than the VATS group in terms of intraoperative blood loss, total postoperative drainage, postoperative drainage time, and postoperative hospital stay. As for hospitalization costs, the VATS group was more advantageous. In the H-BMI group, subgroup analysis showed a statistically significant difference in shorter operative time and lower incidence of postoperative complications in the RATS group. CONCLUSION: RATS has technical and short-term efficacy advantages in comparison with VATS, although it has the drawback of high costs associated with the treatment of mediastinal tumors. In the patients with mediastinal tumors of H-BMI, RATS can achieve better short-term outcomes and safety, especially in the reduction of the incidence of postoperative complications.

Multicenter exploration of specialist palliative care in patients with left ventricular assist devices - a retrospective study.

BACKGROUND: The number of advanced heart failure patients with left ventricular assist devices (LVAD) is increasing. Despite guideline-recommendations, little is known about specialist palliative care involvement in LVAD-patients, especially in Europe. This study aims to investigate timing and setting of specialist palliative care in LVAD-patients. METHODS: We conducted a retrospective multicenter study in 2022. Specialist palliative care services in German LVAD-centers were identified and invited to participate. Forty adult LVAD-patients (mean age 65 years (SD 7.9), 90% male) from seven centers that received a specialist palliative care consultation during hospitalization were included. RESULTS: In 37 (67.3%) of the 55 LVAD-centers, specialist palliative care was available. The median duration between LVAD-implantation and first specialist palliative care contact was 17 months (IQR 6.3-50.3 months). Median duration between consultation and death was seven days (IQR 3-28 days). 65% of consults took place in an intensive/intermediate care unit with half of the patients having a Do-Not-Resuscitate order. Care planning significantly increased during involvement (advance directives before: n = 15, after: n = 19, p < 0.001; DNR before: n = 20, after: n = 28, p < 0.001). Symptom burden as assessed at first specialist palliative care contact was higher compared to the consultation requests (request: median 3 symptoms (IQR 3-6); first contact: median 9 (IQR 6-10); p < 0.001) with a focus on weakness, anxiety, overburdening of next-of-kin and dyspnea. More than 70% of patients died during index hospitalization, one third of these in a palliative care unit. CONCLUSIONS: This largest European multicenter investigation of LVAD-patients receiving specialist palliative care shows a late integration and high physical and psychosocial symptom burden. This study highlights the urgent need for earlier integration to identify and address poorly controlled symptoms. Further studies and educational efforts are needed to close the gap between guideline-recommendations and the current status quo.

The impact of hypertension on clinical outcomes in moyamoya disease: a multicenter, propensity score-matched analysis.

BACKGROUND: Moyamoya disease (MMD) is a rare cerebrovascular disorder characterized by progressive steno-occlusive changes in the internal carotid arteries, leading to an abnormal vascular network. Hypertension is prevalent among MMD patients, raising concerns about its impact on disease outcomes. This study aims to compare the clinical characteristics and outcomes of MMD patients with and without hypertension. METHODS: We conducted a multicenter, retrospective study involving 598 MMD patients who underwent surgical revascularization across 13 academic institutions in North America. Patients were categorized into hypertensive (n=292) and non-hypertensive (n=306) cohorts. Propensity score matching (PSM) was performed to adjust for baseline differences. RESULTS: The mean age was higher in the hypertension group (46 years vs. 36.8 years, p < 0.001). Hypertensive patients had higher rates of diabetes mellitus (45.2% vs. 10.7%, p < 0.001) and smoking (48.8% vs. 27.1%, p < 0.001). Symptomatic stroke rates were higher in the hypertension group (16% vs. 7.1%; OR: 2.48; 95% CI: 1.39-4.40, p = 0.002) before matching. After PSM, there were no significant differences in symptomatic stroke rates (11.1% vs. 7.7%; OR: 1.5; CI: 0.64-3.47, p = 0.34), perioperative strokes (6.2% vs. 2.1%; OR 3.13; 95% CI: 0.83-11.82, p = 0.09), or good functional outcomes at discharge (93% vs. 92.3%; OR 1.1; 95% CI: 0.45-2.69, p = 0.82). CONCLUSION: No significant differences in symptomatic stroke rates, perioperative strokes, or functional outcomes were observed between hypertensive and non-hypertensive Moyamoya patients. Appropriate management can lead to similar outcomes in both groups. Further prospective studies are required to validate these findings.

Long term mechanical failure in well aligned adult spinal deformity patients.

BACKGROUND CONTEXT: Mechanical complications (MC) are frequently linked to suboptimal postoperative alignment and represent a primary driver of revision surgery in the context of Adult Spinal Deformity (ASD). However, it's worth noting that even among those deemed "well aligned," the risk of experiencing MCs persists, hinting at the potential influence of factors beyond alignment. PURPOSE: The aim was to assess the incidence of MCs among well-aligned patients and delving into the relevant risk factors and surgical outcomes that come into play within this specific subgroup. STUDY DESIGN/SETTING: A retrospective analysis was conducted using data from a prospective multicenter database dedicated to ASD. PATIENT SAMPLE: The study focused on patients aged 55 years or older, who had a minimum follow-up period of 2 years, and exhibited a Global Alignment and Proportion (GAP) score of 2 points or less (excluding age) within 6 weeks of their index surgery. OUTCOME MEASURES: Mechanical complications such as rod fractures, pseudarthrosis, or junctional kyphosis or failure, METHODS: Patients who developed mechanical complications were identified. Comparative analyses were performed, encompassing both continuous and categorical variables. Furthermore, binary logistic regression tests were employed to pinpoint risk factors, and ROC curves were used to determine the optimal threshold values for these variables. RESULTS: A total of 83 patients met the inclusion criteria for this study, with a mean age of 66 years. On average, they had 10 instrumented levels, and 77% of them had fusion extending to the pelvis. Additionally, 27% of the patients had undergone 3-column osteotomies (3-CO). Among them, 33 patients (40%) experienced at least 1 MC during an average follow-up period of 4 years, which included 14 cases of proximal junctional kyphosis (PJK) and 20 cases of nonunion or rod breakage. 15 patients (18%) required revision surgery specifically for MC. In univariable analyses, patients who developed MC were characterized by higher body weight, poorer baseline general health (as indicated by worse SF-36 scores), and less favorable preoperative coronal and sagittal alignment. They also had longer hospital stays, a greater number of instrumented levels, and achieved less favorable postoperative coronal and sagittal alignment. Interestingly, factors such as 3-column osteotomies, postoperative bracing, and the addition of an anterior approach did not significantly alter the risk of MC in well-aligned adult spinal deformity (ASD) patients. Binary regression models revealed that independent risk factors for MC included the residual coronal lumbosacral curve, the number of instrumented levels, and Relative Spinopelvic Alignment (RSA). ROC curves identified an optimal threshold of a residual lumbosacral curve of ≤4° and RSA of ≤3°. Moreover, the rate of MCs showed a stepwise increase within the GAP-Proportioned group, with rates of 31% for GAP=0, 54% for GAP=1, and 75% for GAP=2, with RSA emerging as the most influential parameter. Lastly, patients with MC exhibited poorer functional and radiological outcomes at their last follow-up assessment. CONCLUSIONS: The rate of MCs remains elevated in sagittally "well-aligned" ASD patients that can be attributed to suboptimal residual sagittal and coronal malalignment, which in turn leads to poorer functional outcomes. This study reaffirms the multifaceted nature of MCs and underscores the significance of achieving impeccable postoperative alignment, particularly in the presence of additional risk factors such as extensive surgical correction, a high lever arm (involving instrumented vertebrae), excessive body weight, and frailty (as indicated by SF-36 scores).

Survival predictors in patients with pancreatic cancer on liposomal irinotecan plus fluorouracil/leucovorin: a multicenter observational study.

Background: Approximately half of the patients with advanced pancreatic ductal adenocarcinoma (PDAC) receive subsequent lines of chemotherapy. Recently, the liposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (5-FU/LV) regimen is recommended as subsequent lines of chemotherapy. However, little is known about the predictive factors for the nal-IRI + 5-FU/LV regimen, especially in patients with previous irinotecan (IRI) exposure. Objectives: We investigated the predictive factors associated with nal-IRI + 5-FU/LV treatment in patients with PDAC. Design: Multicenter, retrospective cohort study. Methods: This study included patients with advanced PDAC who received the nal-IRI + 5-FU/LV regimen for palliative purposes. Results: Overall, 268 patients were treated with nal-IRI + 5-FU/LV. The median overall survival (OS) was 7.9 months (95% confidence interval (CI): 7.0-8.8), while the median progression-free survival (PFS) was 2.6 months (95% CI: 1.9-3.2). An albumin level of<4.0 g/dL, neutrophil-to-lymphocyte ratio (NLR) of ⩾3.5, liver or peritoneal metastasis, and a history of >3 lines of palliative chemotherapy were associated with worse OS. An NLR of ⩾3.5 and liver metastasis were significant predictive factors for worse PFS. Previous exposure to IRI was not a significant predictor. Patients without prior IRI (no-IRI) treatment showed relatively longer OS and PFS compared to IRI responders and nonresponders, but these differences were not significant when compared specifically to the responders (OS: 8.8 vs 8.1 months, p = 0.388; PFS: 3.6 vs 2.6 months, p = 0.126). Conclusion: An NLR of ⩾3.5 and liver metastasis were associated with worse PFS. Prior IRI exposure was not a significant predictive factor for OS and PFS, especially in IRI responders.

Impact of causative organism identification on clinical outcomes after minimally invasive posterior fixation for thoracolumbar pyogenic spondylitis: multicenter retrospective cohort study.

PURPOSE: This study aimed to evaluate the difference in treatment duration and unplanned additional surgeries between patients with unidentified causative organisms on empiric antibiotics and those with identified organisms on selective antibiotics in treating thoracolumbar pyogenic spondylitis with minimally invasive posterior fixation. METHODS: This multicenter retrospective cohort study included patients with thoracolumbar pyogenic spondylitis refractory to conservative treatment who underwent minimally invasive posterior fixation. Patients were divided into the identified (known causative organism) and unidentified groups (unknown causative organism). We analyzed data on demographics, antibiotic use, surgical outcomes, and infection control indicators. RESULTS: We included 74 patients, with 52 (70%) and 22 (30%) in the identified and unidentified groups, respectively. On admission, the identified group had higher C-reactive protein (CRP) levels and more iliopsoas abscesses. The duration to postoperative CRP negative was similar in the identified and unidentified groups (7.13 vs. 6.48 weeks, p = 0.74). Only the identified group had unplanned additional surgeries due to poor infection control, affecting 6 of 52 patients (12%). Advanced age and causative organism identification increased the additional surgery odds (odds ratio [OR], 8.25; p = 0.033 and OR, 6.83; p = 0.034, respectively). CONCLUSION: The use of empiric antibiotics in minimally invasive posterior fixation was effective without identifying the causative organism and did not prolong treatment duration. In patients with identified organisms, 12% required unplanned additional surgery, indicating a more challenging infection control. Causative organism identification was associated with the need for additional surgery, suggesting a more cautious treatment strategy for these patients.

The presentation pattern and surgical strategies in bronchopulmonary carcinoid tumors: a multicenter experience in a low-income country.

Background: Bronchopulmonary carcinoid tumors include typical and atypical carcinoids, with typical carcinoids accounting for 80%-90% of these types of tumor. The primary curative treatment for these tumors is surgical resection. To our knowledge, there are limited studies on the presentation patterns and treatment strategies of bronchopulmonary carcinoid tumors in Africa. Objective: To determine the presentation patterns and surgical strategies in bronchopulmonary carcinoid tumors in patients treated at multicenters in Ethiopia from January 2018 to December 2023. Materials and methods: A 5-year retrospective cross-sectional study was conducted using medical records and pathology record reviews of patients operated on in Tikur Anbessa Specialized Hospital, Menelik II Hospital, and Saint Peter's Specialized Hospital from 1 January 2018 to 31 December 2023. The completeness of the data was checked before being entered into EpiData version 4.6.1, and analysis was conducted using SPSS version 29. Logistic regression was applied to depict the association of the histological pattern with its predictors. A P-value of <0.05 was considered significant for the association of variables. Results: A total of 62 patients with bronchopulmonary carcinoid tumors were included in the study with a mean age of 35.29 ± 12.26 years ranging from 14 to 67 years, in which more than half [37 (56.5%)] were females, with a male-to-female ratio of 1:1.3. The majority of the patients were non-smokers (90.3%) and symptomatic (98.4%), with a mean duration of symptoms of 29.7 ± 26 months, ranging from 3 to 156 months. Nearly half of the patients (48.4%) were treated for pulmonary tuberculosis before a diagnosis of carcinoid tumor was made. The majority of the patients underwent surgery by open posterolateral thoracotomy (98.4%), and pneumonectomy was the most common (38.7%) resection performed. Typical carcinoids were observed in 85.5% of patients. Age, smoking history, duration of symptoms, location of tumors, and lymph node status were statistically associated with histological patterns. Recommendation: Based on our study findings, improving physician awareness on the clinical presentation of carcinoid tumors, training for surgeons in less invasive surgical approaches, and further nationwide studies are recommended.

A randomized, multicenter phase III Study of once-per-cycle administration of efbemalenograstim alfa (F-627), a novel long-acting rhG-CSF, for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer.

BACKGROUND: F-627 (efbemalenograstim alfa) is a novel long acting granulocyte colony-stimulating factor (G-CSF) that contains two human G-CSF fused to a human immunoglobulin G2 (hIgG2) -Fc fragment with a peptide linker. This studyevaluated the efficacy and safety of F-627, also known as efbemalenograstim alfa (Ryzneuta®) in reducing neutropenia compared with filgrastim (GRAN®). METHODS: This was a multicenter, randomized, open-label, active-controlled non-inferiority study. Two hundred thirty nine (239) patients were enrolled in thirteen centers and received the chemotherapy with epirubicin (100 mg/m2) and cyclophosphamide (600 mg/m2) on day 1 of each cycle for a maximum of four cycles. Patients were randomized to receive either a single 20 mg subcutaneous (s.c.) injection of F-627 on day 3 of each cycle or daily s.c. injection of filgrastim 5 µg/kg/d starting from day 3 of each cycle. The primary endpoint was the duration of grade 3 or 4 neutropenia in cycle 1. The safety profile was also evaluated. RESULTS: The mean (SD) duration of grade 3 or 4 neutropenia in cycle 1 was 0.68 (1.10) and 0.71 (0.95) days for the F-627 and the filgrastim groups, respectively. The Hodges-Lehmann estimate of the between-group median difference (F-627 vs filgrastim) in the duration of grade 3 or 4 neutropenia in cycle 1 was 0 day and the upper limit of the one-sided 97.5% CI was 0 day, which was within the prespecified non-inferiority margin of 1-day. Results for all efficacy endpoints in cycles 2 - 4 were consistent with the results in cycle 1, however a trend towards a lower incidence and a shorter duration of grade 3 or 4 neutropenia and grade 4 neutropenia was observed in the F-627 group compared with the filgrastim group. The ANC nadir in the F-627 group was significantly higher than that in the filgrastim group in each cycle. A single fixed dose of F-627 was well tolerated and as safe as standard daily filgrastim. CONCLUSIONS: A single fixed dose of 20 mg of F-627 in each cycle was as safe and effective as a daily dose of filgrastim 5 µg/kg/d in reducing neutropenia and its complications in patients who received four cycles of EC. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04174599, on 22/11/2019.

A Review of Authorship Inflation and Multicenter Collaboration Trends in Orthopedic, Medical, and Surgical Journals Over the Last 60 Years.

Over the past six decades, authorship numbers in academic publications have increased significantly, a phenomenon known as authorship inflation. This study aims to analyze comparative authorship trends and the influence of multicenter collaborations across major orthopedic, medical, and surgical journals. We reviewed metadata from The New England Journal of Medicine (NEJM), Annals of Surgery (AS), and The Journal of Bone and Joint Surgery (JBJS) from January 1, 1960, to December 31, 2019. The number of authors per publication, the prevalence of multicenter studies, and their correlation were analyzed. Data was visualized using heat maps and box plots, and trends were statistically tested using the Jonckheere-Terpstra, Mann-Kendall, and generalized linear mixed models (GLMMs). A total of 73,062 articles were analyzed, with 1,190 articles identified as originating from multicenter studies. The number of multicenter trials was found to have increased significantly over time (p < 0.001), plateauing in NEJM but continuing to rise in JBJS and AS. There was a significant increase in authorship numbers per publication over time, across all journals (p < 0.0001). There was a significant statistical correlation (p < 0.0001) as indicated by the coefficient of determination (r2), for the association between the proportion of publications with >10 authors and the proportion of multicenter publications across all three journals. Authorship inflation in academic publishing may be attributable to the rise in multicenter collaborations. The rate of increase in authorship was more pronounced in medical and surgical journals compared to orthopedic journals, reflecting differing trends across specialties. These findings highlight the evolving nature of research collaboration and authorship practices in academic publishing.