Multicenter Collaborative Study Research Articles

Editorial Comment on Japanese survey of perioperative complications and ureteral stricture after ureteroscopy with laser lithotripsy for upper urinary tract stones in multicenter collaborative study.

Editorial Comment on Japanese survey of perioperative complications and ureteral stricture after ureteroscopy with laser lithotripsy for upper urinary tract stones in multicenter collaborative study.

A Narrative Review of Neurological Complications of SARS-CoV-2 Vaccination

AbstractAdverse reactions to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine depict a tropism for neural structures. This narrative review was aimed to discuss published data on the spectrum of neurological side effects of SARS-CoV-2 vaccines, which were accorded emergency use authorization. The majority of the neurological manifestations of SARS-CoV-2 vaccination are usually mild, brief, self-limiting, and easily manageable. Rarely, these side effects can be of serious nature and require hospitalization. High vigilance helps in early identification and treatment of these complications leading to good outcomes. The reported incidence of neurological complications in vaccinated population is a miniscule, and the overall benefits of the vaccine outweigh the risks of side effects. However, it is crucial to conduct larger collaborative multicenter studies to prove or reject the causal association between the SARS-CoV-2 vaccines and the postvaccination neurological side effects. Herein, we have tried to summarize the various neurological manifestations related to SARS-CoV-2 vaccines published in the literature from 2021 to mid-2023.

Japanese survey of perioperative complications and ureteral stricture after ureteroscopy with laser lithotripsy for upper urinary tract stones in multicenter collaborative study.

This study aimed to investigate perioperative complications and the details of postoperative ureteral stricture after ureteroscopy with laser lithotripsy (URS-L) for upper urinary tract stones in Japan. Patient data on intra- and postoperative complications after ureteroscopy using URS-L were retrospectively collected from multiple centers in Japan between April 2017 and March 2020 with the cooperation of the Japanese Society of Endourology and Robotics. Data included the number of patients undergoing URS-L, number and type of intra- and postoperative complications, and detailed characteristics of postoperative ureteral stricture. In total, 14 125 patients underwent URS-L over 3 years at 82 institutions. Annual URS-L numbers gradually increased from 4419 in 2017, to 4760 in 2018, and 4946 in 2019. The total complication rate was 10.5%, which was divided into intra-operative complications in 1.40% and postoperative complications in 9.18%. The annual incidences of intra- and postoperative complications were not significantly different from year to year (p = 0.314 and p = 0.112). Ureteral perforation, ureteral avulsion, and the intra-operative conversion rate were 1.35%, 0.03%, and 0.02%, respectively. Fever >38°C, septic shock, blood transfusion, and postoperative mortality were 7.44%, 0.81%, 0.07%, and 0.04%, respectively. Ureteral stricture occurred in 0.8% of cases. The median length of stricture site was 10.0 mm and the success rate of stricture treatment was 54.6%. Although URS-L utilization has increased in Japan, the annual complication rate has remained steady. Although URS-L is a useful and less invasive procedure, devastating complications can still occur.

Multicenter registry of pediatric inflammatory bowel disease from a developing country

BackgroundDespite the rising incidence of pediatric inflammatory bowel disease (PIBD) globally, multicenter collaborative studies of PIBD children among developing countries remain sparse. We therefore aimed to define the initial presentation and short-term outcomes of Thai children with PIBD from a multicenter registry.MethodsFour teaching hospitals participated in this study. A diagnosis of PIBD requires gastrointestinal endoscopy and histopathology in children aged < 19 years. Besides demographics, we collected clinical information and treatment with the data at 1-year follow up.ResultsWe included 35 Crohn’s disease (CD), one IBD-unclassified, and 36 ulcerative colitis (UC) children (total n = 72 with 60.6% males). The mean age at diagnosis was 7.9 years (SD 4.1) with 38% being very early onset IBD (VEO-IBD). When compared with UC, the CD children were more likely to exhibit fever (42.3 vs. 13.9%), weight loss/failure to thrive (68.6 vs. 33.3%), and hypoalbuminemia (62.9 vs. 36.1%) but less likely to have bloody stools (51.4 vs. 91.7%) (all P < 0.05). No significant differences in demographics, clinical data and medications used with regards to VEO-IBD status. At 1 year after diagnosis (n = 62), 30.7% failed to enter clinical remission and 43.7% remained on systemic corticosteroids. Diarrhea (OR 9.32) and weight issues (OR 4.92) at presentation were independent predictors of failure to enter clinical remission; and females (OR 3.08) and CD (vs. UC) (OR 3.03) were predictors of corticosteroids use at 1-year follow-up.ConclusionsA high proportion of VEOIBD is noted, and CD was more likely to present with significant inflammatory burden. Diarrhea and weight issues at presentation were independent predictors of failure to enter clinical remission; and females and CD (vs. UC) were predictors of corticosteroids use at 1-year follow-up.

Biologic Therapy in Rare Eosinophil-Associated Disorders: Remaining Questions and Translational Research Opportunities.

Rare eosinophil-associated disorders (EADs), including hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis and eosinophilic gastrointestinal disorders, are a heterogeneous group of conditions characterized by blood and/or tissue hypereosinophilia and eosinophil-related clinical manifestations. Although the recent availability of biologic therapies that directly and indirectly target eosinophils has the potential to dramatically improve treatment options for all EADs, clinical trials addressing their safety and efficacy in rare EADs have been relatively few. Consequently, patient access to therapy is limited for many biologics, and the establishment of evidence-based treatment guidelines has been extremely difficult. In this regard, multicenter retrospective collaborative studies focusing on disease manifestations and treatment responses in rare EADs have provided invaluable data for physicians managing patients with these conditions and helped identify important questions for future translational research. During the Clinical Pre-Meeting Workshop held in association with the July 2023 biennial meeting of the International Eosinophil Society in Hamilton, Ontario, Canada, the successes and limitations of pivotal multicenter retrospective studies in EADs were summarized, and unmet needs regarding the establishment of guidelines for use of biologics in rare EADs were discussed. Key topics of interest included: 1) clinical outcome measures, 2) minimally invasive biomarkers of disease activity, 3) predictors of response to biologic agents, and 4) long-term safety of eosinophil depletion. Herein, we report a summary of these discussions, presenting a state-of-the-art overview of data currently available for each of these topics, the limitations of the data, and avenues for future data generation through implementation of multidisciplinary and multicenter studies.

BROLUCIZUMAB FOR WET-AGED RELATED MACULAR DEGENERATION PATIENTS : TOO GOOD TO BE TRUE

Introduction &amp; Objective: Brolucizumab is the newest anti-vascular endothelial growth factor (anti-VEGF) drug. It showed superior anatomic outcomes compared to other anti-VEGF and noniferiority best corrected visual acuity (BCVA) results for Wet-Aged Related Macular Degeneration (Wet-AMD) patients. In Yogyakarta, its been only used in few patients and we want to report the Effectiveness and safety of brolucizumab in Wet-AMD patients in Yogyakarta. Method: In this retrospective study, all neovascular AMD (nAMD) Patients who underwent brolucizumab intravitreal injections between December 2021 and January 2023 at YAP Eye Hospital were studied. Patient’s demographic data, before and after intravitreal brolucizumab injections (central subfield thickness, intraocular pressure and BCVA) were assessed. Result :This study included 6 eyes of 6 patients ( 3 women) with a mean age of 69.5 years old. The mean follow- up period was 27 ± 10.1 weeks after the first injection of brolucizumab. Three patients were naïve nAMD patient, never got any intravitreal injections and three anti-VEGF experienced nAMD patients with ranibizumab or aflibercept injections prior to brolucizumab. Mean BCVA at baseline (before brolucizumab injection) was 0.12 decimal (6/48) and was 0.29 decimal (6/20) at the last follow-up. Five out of six patients visual acuity were improved,one patient had constant bcva. Four out of six patient central subfield thickness were reduced, none of the patient intraocular pressure increased over 21 mmhg. None of the patient reported any signs of inflammation, vasculitis, or any other ocular or systemic adverse effects. Conclusion :This limited data demonstrated that brolucizumab was safe and effective in stabilizing BCVA for both of nAMD patients who had undergone previous treatment with other anti-VEGFs agents and naive. Future larger multicenter collaborative studies are warranted.

Efficacy and safety of atezolizumab/bevacizumab for hepatocellular carcinoma in a real-life prospective cohort: data from a multicenter collaborative study

Efficacy and safety of atezolizumab/bevacizumab for hepatocellular carcinoma in a real-life prospective cohort: data from a multicenter collaborative study

Accuracy and Completeness of ChatGPT-Generated Information on Interceptive Orthodontics: A Multicenter Collaborative Study

Background: this study aims to investigate the accuracy and completeness of ChatGPT in answering questions and solving clinical scenarios of interceptive orthodontics. Materials and Methods: ten specialized orthodontists from ten Italian postgraduate orthodontics schools developed 21 clinical open-ended questions encompassing all of the subspecialities of interceptive orthodontics and 7 comprehensive clinical cases. Questions and scenarios were inputted into ChatGPT4, and the resulting answers were evaluated by the researchers using predefined accuracy (range 1–6) and completeness (range 1–3) Likert scales. Results: For the open-ended questions, the overall median score was 4.9/6 for the accuracy and 2.4/3 for completeness. In addition, the reviewers rated the accuracy of open-ended answers as entirely correct (score 6 on Likert scale) in 40.5% of cases and completeness as entirely correct (score 3 n Likert scale) in 50.5% of cases. As for the clinical cases, the overall median score was 4.9/6 for accuracy and 2.5/3 for completeness. Overall, the reviewers rated the accuracy of clinical case answers as entirely correct in 46% of cases and the completeness of clinical case answers as entirely correct in 54.3% of cases. Conclusions: The results showed a high level of accuracy and completeness in AI responses and a great ability to solve difficult clinical cases, but the answers were not 100% accurate and complete. ChatGPT is not yet sophisticated enough to replace the intellectual work of human beings.

On dosimetric characteristics of detectors for relative dosimetry in small fields: a multicenter experimental study

Objective. In this multicentric collaborative study, we aimed to verify whether the selected radiation detectors satisfy the requirements of TRS-483 Code of Practice for relative small field dosimetry in megavoltage photon beams used in radiotherapy, by investigating four dosimetric characteristics. Furthermore, we intended to analyze and complement the recommendations given in TRS-483. Approach. Short-term stability, dose linearity, dose-rate dependence, and leakage were determined for 17 models of detectors considered suitable for small field dosimetry. Altogether, 47 detectors were used in this study across ten institutions. Photon beams with 6 and 10 MV, with and without flattening filters, generated by Elekta Versa HDTM or Varian TrueBeamTM linear accelerators, were used. Main results. The tolerance level of 0.1% for stability was fulfilled by 70% of the data points. For the determination of dose linearity, two methods were considered. Results from the use of a stricter method show that the guideline of 0.1% for dose linearity is not attainable for most of the detectors used in the study. Following the second approach (squared Pearson’s correlation coefficient r 2), it was found that 100% of the data fulfill the criteria r 2 > 0.999 (0.1% guideline for tolerance). Less than 50% of all data points satisfied the published tolerance of 0.1% for dose-rate dependence. Almost all data points (98.2%) satisfied the 0.1% criterion for leakage. Significance. For short-term stability (repeatability), it was found that the 0.1% guideline could not be met. Therefore, a less rigorous criterion of 0.25% is proposed. For dose linearity, our recommendation is to adopt a simple and clear methodology and to define an achievable tolerance based on the experimental data. For dose-rate dependence, a realistic criterion of 1% is proposed instead of the present 0.1%. Agreement was found with published guidelines for background signal (leakage).

Liver Transplantation Research from India During the Last 25 Years: 1998–2022

Liver transplant surgery has been performed in India for the last 25 years. We aimed to analyse the trends, characteristics, and key elements in the field of liver transplantation research from India. On April 23, 2023, we conducted a search of the Scopus database for the literature on liver transplantation research, using a well-defined search strategy. MS Excel and VOS viewersoftware programs were used to examine the articles for organisation, author, journal, keywords, and high-cited literature. This analysis examined a total of 556 papers, which constituted only a 1.55% share of the global output. These papers involved 442 organizations, 1575 authors, and 147 journals. External funding was received in 4.13% and 23.56% were involved in international collaboration. Three Delhi-NCR organizations, namely the Medanta-The Medicity (n=63), Institute of Liver & Biliary Sciences (n=60), and Indraprastha Apollo Hospital (n=48) led in publication productivity. M. Rela (n=90) and A.S. Soin (n=63) were the leading authors in publication productivity, while S. Sudhindran and P. Bhangui were the most impactful authors. Liver Transplantation (n=96) and Journal of Clinical & Experimental Hepatology (n=65) published the maximum number of these papers, whereas, Annals of Surgery and Journal of Hepatology led in the citation impact per paper. The most significant keywords were "Liver Transplantation" (n=484), and "Living Donor" (n=254). Only 1.80% (n=10) of the papers were highly cited papers that received 50 to 142 citations and they together registered 69.9 citations per paper. Although the number of publications on liver transplantation from India started growing recently, it forms only 1.55% of the global report. There is an unmet need to increase government-supported research and multicenter collaborative studies at national and international levels for high-quality patient care.

The impact of the COVID-19 pandemic on hepatocellular carcinoma diagnosis and treatment in Japan: A multicenter collaborative observational study.

Coronavirus disease 2019 emerged in December 2019 and spread worldwide. This study aimed to clarify the impact of the coronavirus disease 2019 pandemic on the diagnosis and treatment of hepatocellular carcinoma (HCC) in Japan. First, we collected the monthly numbers of HCC-related general medical practices from January 2019 to December 2021 at liver disease-specific medical institutions in Japan. Next, we collected individual clinical information from patients with newly diagnosed HCC during this period. There was a decrease in the number of HCC-related medical practices, including referrals, enhanced abdominal ultrasonography and radiofrequency ablation, in Japan's first state of emergency (SOE; April-May 2020) compared with 2019. Fewer patients were diagnosed with new HCC during the first SOE than before or after it. There was no difference in tumor diameter, number of tumors or Barcelona Clinic Liver Cancer stage between patients diagnosed before the first SOE and those diagnosed during or after the first SOE. The median waiting times for treatment of patients diagnosed during and after the first SOE were 31 and 37days, which were significantly shorter and not longer than that of patients diagnosed before the first SOE (36days), respectively. The number of HCC-related general medical practices decreased during the first SOE. However, the coronavirus disease 2019 pandemic did not lead to HCC progression by diagnostic delays or cause HCC treatment delays in Japan.

Surgical multicenter collaborative studies: what happens in Latin America?

Surgical multicenter collaborative studies: what happens in Latin America?

Assessment of the performance of the Ames MPF™ assay: A multicenter collaborative study with six coded chemicals

The Ames MPF™ is a miniaturized, microplate fluctuation format of the Ames test. It is a standardized, commercially available product which can be used to assess mutagenicity in Salmonella and E. coli strains in 384-well plates using a color change-based readout. Several peer-reviewed comparisons of the Ames MPF™ to the Ames test in Petri dishes confirmed its suitability to evaluate the mutagenic potential of a variety of test items. An international multicenter study involving seven laboratories tested six coded chemicals with this assay using five bacterial strains, as recommended by the OECD test guideline 471. The data generated by the participating laboratories was in excellent agreement (93%), and the similarity of their dose response curves, as analyzed with sophisticated statistical approaches further confirmed the suitability of the Ames MPF™ assay as an alternative to the Ames test on agar plates, but with advantages with respect to significantly reduced amount of test substance and S9 requirements, speed, hands-on time and, potentially automation.

Sudden cardiac death in childhood RASopathy-associated hypertrophic cardiomyopathy: validation of HCM Risk-Kids model and predictors of events

Abstract RASopathies represent an important proportion of hypertrophic cardiomyopathy (HCM) cases presenting in childhood. Despite this, there are no published risk factors for sudden cardiac death (SCD) in this cohort of patients. Our primary aim was to validate the HCM Risk-Kids model in children with RASopathy-associated HCM and to investigate additional predictors of SCD in a cohort of 169 patients from 15 international paediatric cardiology centres (UK, Ireland and Germany). Eleven (6.5%) patients experienced a SCD equivalent event [5 (45.5%) an aborted cardiac arrest; 3 (27.3%) SCD; 2 (18.2%) sustained ventricular tachycardia (VT); and 1 (9.1%) appropriate implantable cardioverter-defibrillator (ICD) shock] at a median age of 12.5 months (IQR 7.7-28.64). The calculated SCD equivalent event incidence was 0.78 (95% CI 0.43 – 1.41) per 100 patient years. Six patients (54.54%) with a SCD equivalent event were in the low-risk category according to the HCM Risk-Kids model. Harrell’s C index was 0.5959 (95% CI 0.26-1.22) with a sensitivity of 9.09%, specificity of 63.92%, positive predictive value of 1.72%, and negative predictive value of 90.99%; there was poor distinction between the different risk groups. Unexplained syncope (HR 102.63 (95% CI 14.94 – 704.99), p&amp;lt;0.001) and non-sustained VT [NSVT (HR 5.67 (95% CI 1.30 – 24.70), p=0.021)] were independent predictors of SCD. The HCM Risk-Kids model should not be used for patients with RASopathy-associated HCM but NSVT and unexplained syncope appear to be predictors of SCD in this population. Larger multicentre collaborative studies are required to further investigate predictors of SCD in this group of patients.

Abstract 14744: Driving Distance to a Primary Cardiac Center is Associated With Mortality in Patients With Tetralogy of Fallot Undergoing Neonatal Interventions

Introduction: Advances in tetralogy of Fallot care have improved survival, however, associations of sociodemographic disparities and mortality are less well described, particularly among patients with symptomatic tetralogy of Fallot (sTOF) requiring neonatal intervention. Our multicenter Congenital Cardiac Research Collaborative (CCRC) study investigated sociodemographic factors associated with mortality in sTOF patients. Hypothesis: Sociodemographic factors related to a lower socioeconomic status are associated with increased mortality in patients with sTOF. Methods: Retrospective cohort study of neonates with sTOF receiving surgical or catheter-based palliation or primary repair at &lt;30 days old from 1/2005 - 11/2017 at one of nine U.S. centers in the CCRC. Primary outcome variable was mortality at last follow up. Primary predictor variable was childhood opportunity index (COI), a national composite score based on 29 neighborhood-level indicators of poor vs excellent health. Secondary predictor variables included distance to primary cardiac center, race/ethnicity, and maternal insurance type. Sociodemographic factors were evaluated using multivariable Cox proportional hazard models, adjusting for center and patient anatomic and genetic characteristics resulting in hazard ratios (HR) with 95% CI. Results: There were 417 neonates with sTOF, with an overall follow-up mortality of 10% at median follow-up of 4.8 years (25th - 75th %ile: 2.1 - 8.2). Most patients were male (53%), non-Hispanic White (52%), prenatally diagnosed (58%), and had public insurance (54%). On adjusted multivariable analysis, infants &gt;100 miles from a primary heart center had a 3x higher hazard of mortality (HR 2.94; 95% CI, 1.13-7.61; p=0.026) compared to those living &lt;50 miles from a heart center. All other sociodemographic factors (COI, race/ethnicity, and insurance type) were not significantly associated with mortality on multivariable analysis. Conclusions: Proximity to a specialized pediatric cardiac center remains a significant determinant of survival in neonates with sTOF, emphasizing the importance of access to cardiac care. Sociodemographic impact on patient morbidity and lifelong mortality in TOF requires further investigation.

EUS-guided versus percutaneous liver abscess drainage: A multicenter collaborative study

ABSTRACT Background and Objectives Management of hepatic abscesses has traditionally been performed by image-guided percutaneous techniques. More recently, EUS drainage has been shown to be efficacious and safe. The aim of this study is to compare EUS-guided versus percutaneous catheter drainage (PCD) of hepatic abscesses. Methods Patients who underwent EUS-guided drainage or PCD of hepatic abscesses from January 2018 through November 2021 from 4 international academic centers were included in a dedicated registry. Demographics, clinical data preprocedure and postprocedure, abscess characteristics, procedural data, adverse events, and postprocedure care were collected. Results Seventy-four patients were included (mean age, 63.9 years; 45% male): EUS-guided (n = 30), PCD (n = 44). Preprocedure Charlson Comorbidity Index scores were 4.3 for the EUS group and 4.3 for the PCD group. The median abscess size was 8.45 × 6 cm (length × width) in the EUS group versus 7.3 × 5.5 cm in the PCD group. All of the abscesses in the EUS group were left-sided, whereas the PCD group contained both left- and right-sided abscesses (29 and 15, respectively). Technical success was 100% in both groups. Ten-millimeter-diameter stents were used in most cases in the EUS group, and 10F catheters were used in the PCD group. The duration to resolution of symptoms from the initial procedure was 10.9 days less in the EUS group compared with the PCD group (P &lt; 0.00001). Hospital length of stay was shorter in the EUS group by 5.2 days (P = 0.000126). The EUS group had significantly fewer number of repeat sessions: mean of 2 versus 7.7 (P &lt; 0.00001) and trended toward fewer number of procedure-related readmissions: 10% versus 34%. The PCD group had a significantly higher number of adverse events (n = 27 [61%]) when compared with the EUS group (n = 5 [17%]; P = 0.0001). Conclusions EUS-guided drainage is an efficacious and safe intervention for the management of hepatic abscesses. EUS-guided drainage allows for quicker resolution of symptoms, shorter length of hospital stay, fewer adverse events, and fewer procedural sessions needed when compared with the PCD technique. However, EUS-guided drainage may not be feasible in right-sided lesions.

Lymphoma in Patients with Inflammatory Bowel Disease: A Multicentre Collaborative Study Between GETAID and LYSA.

Inflammatory bowel disease [IBD] is associated with an increased risk of developing lymphoma. Although recent data have clarified the epidemiology of lymphoma in IBD patients, the clinical and pathological characteristics of lymphoma in IBD remain poorly known. Patients with IBD and lymphoma were retrospectively identified in the framework of a national collaborative study including the Groupe d'Étude Thérapeutique des Affections Inflammatoires du Tube Digestif [GETAID] and the Lymphoma Study Association [LYSA]. We characterized clinical and prognostic features for the three most frequent lymphoma subtypes occurring in IBD. We performed a multicentre case-control study. Controls [lymphoma de novo] were matched [5:1] to cases on gender, age at diagnosis, lymphoma subtype, year of diagnosis, and IPI/FLIPI indexes. Overall survival and progression-free survival were compared between cases and controls. In total, 133 IBD patients with lymphoma were included [males = 62.4%, median age at lymphoma diagnosis = 49 years in males; 42 years in females]. Most had Crohn's disease [73.7%] and were exposed to thiopurines [59.4%]. The most frequent lymphoma subtypes were diffuse large B cell lymphoma [DLBCL, 45.1%], Hodgkin lymphoma [HL, 18.8%], and follicular lymphoma [FL, 10.5%]. When matched with 365 controls, prognosis was improved in IBD patients with DLBCL compared to controls [p = 0.0064, hazard ratio = 0.36] or similar [HL and FL]. Lymphomas occurring in IBD patients do not seem to have a worse outcome than in patients without IBD. Due to the rarity of this situation, such patients should be managed in expert centres.

Sudden cardiac death in childhood RASopathy-associated hypertrophic cardiomyopathy: Validation of the HCM risk-kids model and predictors of events

BackgroundRASopathies account for nearly 20% of cases of childhood hypertrophic cardiomyopathy (HCM). Sudden cardiac death (SCD) occurs in patients with RASopathy-associated HCM, but the risk factors for SCD have not been systematically evaluated. AimTo validate the HCM Risk-Kids SCD risk prediction model in children with RASopathy-associated HCM and investigate potential specific SCD predictors in this population. MethodsValidation of HCM Risk-Kids was performed in a retrospective cohort of 169 patients with a RASopathy-associated HCM from 15 international paediatric cardiology centres. Multiple imputation by chained equations was used for missing values related to the HCM Risk-Kids parameters. ResultsEleven patients (6.5%) experienced a SCD or equivalent event at a median age of 12.5 months (IQR 7.7–28.64). The calculated SCD/equivalent event incidence was 0.78 (95% CI 0.43–1.41) per 100 patient years. Six patients (54.54%) with an event were in the low-risk category according to the HCM Risk-Kids model. Harrell's C index was 0.60, with a sensitivity of 9.09%, specificity of 63.92%, positive predictive value of 1.72%, and negative predictive value of 91%; with a poor distinction between the different risk groups. Unexplained syncope (HR 42.17, 95% CI 10.49–169.56, p < 0.001) and non-sustained ventricular tachycardia (HR 5.48, 95% CI 1.58–19.03, p < 0.007) were predictors of SCD on univariate analysis. ConclusionUnexplained syncope and the presence of NSVT emerge as predictors for SCD in children with RASopathy-associated HCM. The HCM Risk-Kids model may not be appropriate to use in this population, but larger multicentre collaborative studies are required to investigate this further.

Characteristics and risk factors of UCS fracture subtypes in periprosthetic fractures around the hip.

Periprosthetic fractures (PPFs) following hip arthroplasty are complex injuries. This study evaluates patient demographic characteristics, management, outcomes, and risk factors associated with PPF subtypes over a decade. Using a multicentre collaborative study design, independent of registry data, we identified adults from 29 centres with PPFs around the hip between January 2010 and December 2019. Radiographs were assessed for the Unified Classification System (UCS) grade. Patient and injury characteristics, management, and outcomes were compared between UCS grades. A multinomial logistic regression was performed to estimate relative risk ratios (RRR) of variables on UCS grade. A total of 1,104 patients were included. The majority were female (57.9%; n = 639), ethnically white (88.5%; n = 977), used mobility aids (67%; n = 743), and had a median age of 82 years (interquartile range (IQR) 74 to 87). A total of 77 (7%) had pain prior to the PPF. The most common UCS grade was B2 (33%; n = 368). UCS type D fractures had the longest length of stay (median 19 days (IQR 11 to 26)), highest readmission to hospital (21%; n = 9), and highest rate of discharge to step-down care (52%; n = 23). Multinomial regression suggests that uncemented femoral stems are associated with a reduced risk of UCS C (RRR 0.36 (95% confidence interval (CI) 0.2 to 0.7); p = 0.002) and increased risk of UCS A (RRR 3.3 (95% CI 1.9 to 5.7); p < 0.001), compared to UCS B fracture. The most common PPF type in elderly frail patients is UCS B2. Uncemented stems have a lower risk of UCS C fractures compared to cemented stems. A national PPF database is needed to further identify correlation between implants and fracture subtypes.

Trans-pacific multicenter collaborative study of minimally invasive proximal versus total gastrectomy for proximal gastric and gastroesophageal junction cancers

BackgroundThe current standard operation for proximal gastric and gastroesophageal junction (P/GEJ) cancers with limited esophageal extension is total gastrectomy (TG). TG is associated with impaired appetite and weight loss due to the loss of gastric functions such as production of ghrelin and with anemia due to intrinsic factor loss and vitamin B12 malabsorption. Theoretically, proximal gastrectomy (PG) can mitigate these problems by preserving gastric function. However, PG with direct esophagogastric reconstruction is associated with severe postoperative reflux, delayed gastric emptying, and poor quality of life (QoL). Minimally invasive PG (MIPG) with antireflux techniques has been increasingly performed by experts but is technically demanding owing to its complexity. Moreover, the actual advantages of MIPG over minimally invasive TG (MITG) with regards to postoperative QoL are unknown. Our overall objective of this study is to determine the short-term QoL benefits of MIPG. Our central hypotheses are that MIPG is safe and that patients have improved appetite after MIPG with effective antireflux techniques, which leads to an overall QoL improvement when compared with MITG.MethodsEnrollment of a total of 60 patients in this prospective survey-collection study is expected. Procedures (MITG versus MIPG, antireflux techniques for MIPG [double-tract reconstruction versus the double-flap technique]) will be chosen based on surgeon and/or patient preference. Randomization is not considered feasible because patients often have strong preferences regarding MITG and MIPG. The primary outcome is appetite level (reported on a 0-10 scale) at 3 months after surgery. With an expected 30 patients per cohort (MITG versus MIPG), this study will have 80% power to detect a one-point difference in appetite level. Patient-reported outcomes will be longitudinally collected (including questions about appetite and reflux), and specific QoL items, body weight, body mass index and ghrelin, albumin, and hemoglobin levels will be compared.DiscussionSurgeons from the US, Japan, and South Korea formed this collaboration with the agreement that the surgical approach to P/GEJ cancers is an internationally important but controversial topic that requires immediate action. At the completion of the proposed research, our expected outcome is the establishment of the benefit and safety of MIPG.Trial registrationThis trial was registered with Clinical Trials Reporting Program Registration under the registration number NCI-2022–00267 on January 11, 2022, as well as with ClinicalTrials.gov under the registration number NCT05205343 on January 11, 2022.