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Background and Aims The application of underwater EMR (UEMR) for nonpolypoid superficial nonampullary duodenal epithelial tumors (SNADETs) has not been comprehensively assessed. Therefore, the current study aimed to validate the efficacy of UEMR versus conventional EMR and cap-assisted EMR (EMRC) for SNADETs measuring ≤20 mm. Methods We retrospectively analyzed patients with sporadic nonpolypoid SNADETs measuring ≤20 mm undergoing EMR, EMRC, or UEMR at Chiba University Hospital between May 2004 and October 2020 (EMR, 21 patients and 23 SNADETs; UEMR, 60 patients and 61 SNADETs; EMRC, 45 patients and 48 SNADETs). A weighted logistic regression analysis was performed to analyze outcomes. Univariate and multivariate logistic regression models were used to identify the predictors of RX/1 and piecemeal resection. The recurrence rate of lesions observed ≥12 months after resection was assessed. Results Both UEMR and EMRC had a significantly higher R0 resection rate than EMR. UEMR had significantly lower multiple resection and postbleeding rates than EMR. Only 1 patient (2.1%) who underwent EMRC experienced intraoperative and postoperative perforation. EMR was involved in RX/1 and piecemeal resection. The recurrence rates of EMR, UEMR, and EMRC were 4.3%, 2.0%, and 6.3%, respectively. Conclusions UEMR had significantly higher R0 resection and lower postbleeding rates than EMR. Moreover, it was safer than EMRC and was associated with a lower incidence of recurrences. The significant results of the retrospective analysis suggest a randomized controlled study with adequate numbers needs to be conducted to confirm the superior efficacy of UEMR before it is recommended for primary treatment option for SNADETs measuring ≤20 mm.

Objective To investigate changes in weight following the initiation of antiretroviral therapy in treatment-naive Asian people living with human immunodeficiency virus (PLWH). Methods This retrospective observational study evaluated adult treatment-naive Asian PLWH who started antiretroviral therapy based on an integrase strand transfer inhibitor, a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor at the AIDS Clinical Centre, Tokyo between January 2005 and February 2019. Patients were followed-up until October 2019. Multi-variate linear mixed-effects models were used to generate marginal predictions of weight over time. Predicted weight was reported at 3-month intervals until censoring or for 5 years after treatment initiation. Results Five years after treatment initiation, average weight gain in PLWH who started on dolutegravir-, darunavir- and elvitegravir-based treatment was 5.3 kg, 4.1 kg and 4.6 kg, respectively, while those who started on raltegravir-, lopinavir- and atazanavir-based treatment gained an average of 1.9 kg, 2.1 kg and 2.3 kg, respectively. Average weight gain in PLWH who started treatment with the backbone drugs, tenofovir alafenamide, abacavir and tenofovir disproxil fumarateb was 4.1 kg, 3.0 kg and 3.0 kg, respectively, and those treated with dolutegravir plus tenofovir alafenamide/emtricitabine gained an average of 6.7 kg. Conclusions Antiretroviral-therapy-associated weight gain continued to increase for 5 years following treatment initiation. A combination of dolutegravir and tenofovir alafenamide/emtricitabine was associated with the greatest weight gain.

Background In double-bundle anterior cruciate ligament reconstruction (ACLR), fixed-loop and adjustable-loop cortical suspensory devices are commonly used to fix the soft graft on the femoral side. However, few studies have compared in vivo elongation of the two devices. The purpose of this study was to determine whether EndoButton CL (EB) and TightRope RT (TR), the suspensory fixation devices used in ACLR, maintained their length in vivo from the time of surgery through the postoperative period in a randomized controlled trial. Methods This study prospectively incorporated 30 patients undergoing initial ACLR at a single center. Participants were divided into two groups using a stratified randomization method with age and sex as assignment adjustment factors. EB or TR was used for fixation of the soft graft on the femoral side. The primary endpoint was to compare the elongation distance of the suspensory device. MRIs were taken within seven days after ACLR and 3,6,12 months postoperatively and measured by a radiologist in a blinded fashion. Secondary endpoints included the side-to-side difference in anterior translation, one leg hop test (HOP index), Lachman test, lateral pivot shift test, and Lysholm score one year postoperatively. Results Twenty-eight patients (EB, n = 13; TR, n = 15) were followed for one year. There was no significant difference between EB and TR groups in elongation from the immediate postoperative period to 3, 6, 12 months after surgery. However, the non-inferiority of TR to EB (non-inferiority margin: 1.5 mm) was not proved by the difference in measured elongation between the two groups (TR – EB, lower 95% CI. AM: 1.80 mm; PL: 1.86 mm) at 6 months. There was no significant difference in anterior translation, HOP index, Lachman test, lateral pivot shift test, or Lysholm score. Conclusion EB and TR had similar graft retaining ability in vivo for 12 months, but the non-inferiority of TR against EB was not verified statistically.

Purpose Increased use of deep convolutional neural networks (DCNNs) in medical imaging diagnosis requires determinate evaluation of diagnostic performance. We performed the fundamental investigation of diagnostic performance of DCNNs using the detection task of brain metastasis. Methods We retrospectively investigated AlexNet and GoogLeNet using 3117 positive and 37961 negative MRI images with and without metastasis regarding (1) diagnostic biases, (2) the optimal K number of K-fold cross validations (K-CVs), (3) the optimal positive versus negative image ratio, (4) the accuracy improvement curves, (5) the accuracy range prediction by the bootstrap method, and (6) metastatic lesion detection by regions with CNNs (R-CNNs). Results Respectively, AlexNet and GoogLeNet had (1) 50 ± 4.6% and 50 ± 4.9% of the maximal mean ± 95% confidence intervals (95% CIs) measured with equal-sized negative versus negative image datasets and positive versus positive image datasets, (2) no less than 10 and 4 of K number in K-CVs fell within the respective maximum biases of 4.6% or 4.9%, (3) 74% of the highest accuracy with equal positive versus negative image ratio dataset and 91% of that with four times of negative-to-positive image ratio dataset, (4) the accuracy improvement curves increasing from 69% to 74% and 73% to 88% as positive versus negative pairs of the training images increased from 500 to 2495, (5) at least nine and six out of 10-CV result sets essential to predict the accuracy ranges by the bootstrap method, and (6) 50% and 45% of metastatic lesion detection accuracies by R-CNNs. Conclusions Our research presented methodological fundamentals to evaluate diagnostic features in the visual recognition of DCNNs. Our series will help to conduct the accuracy investigation of computer diagnosis in medical imaging.

Background Rocuronium consumption with or without intraoperative objective neuromuscular monitoring in clinical settings of unrestricted use of sugammadex and neuromuscular monitoring has not been reported earlier. The study aimed to investigate the association between the use of intraoperative objective neuromuscular monitoring and rocuronium consumption in patients undergoing laparoscopic abdominal surgery. Methods Data were collected by reviewing electronic medical records of patients who received laparoscopic abdominal surgery under general anesthesia with rocuronium and reversal with sugammadex at a university teaching hospital between May 2017 and April 2018. A multivariate linear regression model was developed to compare the amount of rocuronium consumption (mg) per weight (kg) per hour (mg/kg/h) between the group in which intraoperative objective neuromuscular monitoring was used (NMM+ group) and the group in which intraoperative neuromuscular monitoring was not used (NMM− group). Additionally, we performed an interaction test. Results A total of 429 patients were evaluated, with 371 patients (86%) included in the NMM+ group and 58 patients (14%) in the NMM− group. Log-transformed rocuronium consumption between the NMM+ group and NMM− group was not significantly different (back-transformed β coefficients [95% CI]: 1.080 [0.951-1.226]; P = 0.23). Male sex and body mass index (BMI) were independent factors associated with 15% (0.853 [0.788-0.924]; P < 0.001) and 3% (for every 1 kg/m2 increase in BMI) (0.971 [0.963-0.979]; P < 0.001) decrease in intraoperative rocuronium consumption, respectively. A significant interaction was detected only between the use of neuromuscular monitoring and age ≥65 years (β: 0.803 [0.662-0.974]; P = 0.026). Conclusions Although the use of intraoperative objective neuromuscular monitoring was not an individual factor influencing intraoperative rocuronium consumption, this retrospective study demonstrated that the use of intraoperative neuromuscular monitoring reduced rocuronium consumption for approximately 20% of elderly patients (age ≥65 years) undergoing laparoscopic abdominal surgery.

Supplemental Digital Content is available in the text, This study aimed to identify prognostic factors for severe sepsis-related in-hospital mortality using the structural equation model (SEM) analysis with statistical causality. Sepsis data from the Focused Outcomes Research in Emergency Care in Acute Respiratory Distress Syndrome, Sepsis, and Trauma study (FORECAST), a multicenter cohort study, was used. Forty seven observed variables from the database were used to construct 4 latent variables. SEM analysis was performed on these latent variables to analyze the statistical causality among these data. This study evaluated whether the variables had an effect on in-hospital mortality. Overall, 1148 patients were enrolled. The SEM analysis showed that the 72-hour physical condition was the strongest latent variable affecting mortality, followed by physical condition before treatment. Furthermore, the 72-hour physical condition and the physical condition before treatment strongly influenced the Sequential Organ Failure Assessment (SOFA) score with path coefficients of 0.954 and 0.845, respectively. The SOFA score was the strongest variable that affected mortality after the onset of severe sepsis. The score remains the most robust prognostic factor and can facilitate appropriate policy development on care.

Objectives To determine the mortality and causes of death in people living with HIV (PLHIV) in Japan. Design A prospective cohort study at AIDS Clinical Center, Tokyo, which treats approximately 10% of PLHIV in care in Japan. Methods Either PLHIV who visited our center for the first time between January 2005 and December 2014 or PLHIV who started their regular visit before January 2005 and visited us between January and March 2005 were included and followed by the end of 2016. Causes of death were defined according to the CoDe protocol. Results Two thousand, seven hundred and ninety-seven PLHIV were analysed with total of 18 858 person-years of follow-up, which constitutes 14% of the estimated number of PLHIV in care in Japan. One hundred and sixty-five (5.9%) PLHIV died with all-cause mortality rate of 8.75 per 1000 person-years. All-cause mortality rate for PLHIV in care in Japan was estimated to be 8.75 per 1000 person-years (95% CI 5.53-12.0). Among causes of death, AIDS-defining illnesses accounted for 39% and malignancy contributed to 47%. Standardized mortality ratio (SMR) for all-cause mortality, malignancy-related mortality, and suicide were 5.96 (95% CI 5.05-6.87), 7.76 (95% CI 6.02-9.51), and 3.24 (95% CI 1.54-4.94), respectively. Even among the patients who were diagnosed early or without history of AIDS, SMR was four times higher than the general population. Conclusion Mortality of PLHIV, even among those with early diagnosis, is substantially higher than that of the general population in Japan, highlighting the importance of further efforts towards prevention, early diagnosis and prompt treatment initiation.

Importance The current standard induction therapy for antineutrophil cytoplasm antibody (ANCA)-associated vasculitis is the combination of high-dose glucocorticoids and cyclophosphamide or rituximab. Although these regimens have high remission rates, they are associated with considerable adverse events presumably due to high-dose glucocorticoids. Objective To compare efficacy and adverse events between a reduced-dose glucocorticoid plus rituximab regimen and the standard high-dose glucocorticoid plus rituximab regimen in remission induction of ANCA-associated vasculitis. Design, setting, and participants This was a phase 4, multicenter, open-label, randomized, noninferiority trial. A total of 140 patients with newly diagnosed ANCA-associated vasculitis without severe glomerulonephritis or alveolar hemorrhage were enrolled between November 2014 and June 2019 at 21 hospitals in Japan. Follow-up ended in December 2019. Interventions Patients were randomized to receive reduced-dose prednisolone (0.5 mg/kg/d) plus rituximab (375 mg/m2/wk, 4 doses) (n = 70) or high-dose prednisolone (1 mg/kg/d) plus rituximab (n = 70). Main outcomes and measures The primary end point was the remission rate at 6 months, and the prespecified noninferiority margin was -20 percentage points. There were 8 secondary efficacy outcomes and 6 secondary safety outcomes, including serious adverse events and infections. Results Among 140 patients who were randomized (median age, 73 years; 81 women [57.8%]), 134 (95.7%) completed the trial. At 6 months, 49 of 69 patients (71.0%) in the reduced-dose group and 45 of 65 patients (69.2%) in the high-dose group achieved remission with the protocolized treatments. The treatment difference of 1.8 percentage points (1-sided 97.5% CI, -13.7 to ∞) between the groups met the noninferiority criterion (P = .003 for noninferiority). Twenty-one serious adverse events occurred in 13 patients in the reduced-dose group (18.8%), while 41 occurred in 24 patients in the high-dose group (36.9%) (difference, -18.1% [95% CI, -33.0% to -3.2%]; P = .02). Seven serious infections occurred in 5 patients in the reduced-dose group (7.2%), while 20 occurred in 13 patients in the high-dose group (20.0%) (difference, -12.8% [95% CI, -24.2% to -1.3%]; P = .04). Conclusions and relevance Among patients with newly diagnosed ANCA-associated vasculitis without severe glomerulonephritis or alveolar hemorrhage, a reduced-dose glucocorticoid plus rituximab regimen was noninferior to a high-dose glucocorticoid plus rituximab regimen with regard to induction of disease remission at 6 months. Trial registration ClinicalTrials.gov Identifier: NCT02198248.

The extent and duration of long-term recovery of CD4 count, CD4 percentage (CD4%), and CD4/CD8 ratio after initiation of combination antiretroviral therapy (cART) in patients with a suppressed viral load (VL) are largely unknown.Patients infected with human immunodeficiency virus type 1 who started cART between January 2004 and January 2012 and showed persistent viral suppression (VL,200 copies/mL) for ≥4 years were followed up at the AIDS Clinical Center in Tokyo. Change point analysis was used to determine the time point when CD4 count recovery shows a plateau, and a linear mixed model was applied to estimate the CD4 count at this change point.Data were analyzed from 752 patients (93% male; median age, 38 years; median baseline CD4 cell count, 172/µL [interquartile range CD4%, 13.8%]; CD4/CD8 ratio, 0.23). The median follow-up period was 81.2 months, and 91 patients (12.1%) were followed up for10 years. Change point analysis showed that CD4 count, CD4%, and CD4/CD8 ratio continued to increase until 78.6, 62.2, and 64.3 months, respectively, with adjusted means of 590/µL (95% confidence interval, 29.5%, and 0.89, respectively, at the change point. Although CD4 counts ≥500/μL were achieved in 73.8% of the study patients, they were not achieved in 48.2% of those with a baseline CD4 count100/μL. Neither the CD4% nor the CD4/CD8 ratio were normalized in a majority of patients.The results showed lack of normalization of CD4 count, CD4%, and CD4/CD8 ratio to the levels seen in healthy individuals even after long-term successful cART in patients with a suppressed VL.

Background Although CD4 count is an important marker for prognosis of patients infected with HIV-1, how long and how much CD4 count will increase after initiation of cART are still unknown. Hence, the aim of this study is, using change point analysis, to examine the long-term CD4 count restoration among well-controlled HIV-1 patients. Methods In this single-center cohort study at AIDS Clinical Center, Tokyo, we examined HIV-1 infected patients who initiated cART between January 2004 and January 2012 and achieved HIV viral load of 200 copies/mL, discontinuation of cART for >30 days, lost to follow-up for >1 year, initiating chemotherapy for malignancy, or death), or at end of the observation period (September 30, 2015). Change point analysis was performed to determine the time point where the restoration of CD4 count becomes plateau. Results Of 752 patients, 708 (94.2%) were male and 89.9% was MSM. The median age was 39.3 years [IQR, 32–45] and the median baseline CD4 count and %CD4 were 172 cells/mm3 [IQR, 61–254], and 13.8% [IQR, 7.7–18.5], respectively. The median follow-up period was 87.0 months [IQR, 65.2–109.2] and 134 were followed over ten years. With change point analysis, both longitudinal increase of CD4 count and %CD4 increased linearly until 78.6 and 62.2 months, respectively. Stratified by baseline CD4 count (350 cells/mm3), CD4 count increased linearly until 76.2, 62.4, and 58.6 months, respectively. Moreover, the percentage of patient who achieved 500 cells/mm3 during study period was 63.5%, 87.2%, and 92.0%, respectively. Conclusion With change point analysis, restoration of CD4 count and %CD4 continued increasing linearly until 6.5 and 5 years of cART, respectively. Patients with lower baseline CD4 count showed longer CD4 count recovery than those with higher baseline CD4; however, their CD4 count did not recover as high as those with higher baseline CD4 count. Disclosures All authors: No reported disclosures.