Background/Aims: Pathological evaluation is crucial for diagnosing biliary lesions and determining appropriate treatment strategies. However, tissue sampling via the transpapillary route can be difficult. In this study, we aimed to assess the efficacy and safety of a novel tapered-tip sheath system for tissue sampling from biliary strictures. Methods: This single-center, randomized, parallel-group clinical trial included patients aged 20 to 85 years admitted to Kyoto University Hospital for biliary strictures. The patients were randomly assigned (1:1) to a new or conventional method group. The primary outcome was technical success of biopsy at the target bile duct using the assigned method, as determined in accordance with the intention-to-treat principle. Adverse events were assessed in all eligible patients. Results: Fifty-six patients were assessed for eligibility between September 2020 and March 2023; 50 patients were enrolled. The patients were randomly divided into the new (n=25) method group and the conventional (n=25) method group. Technical success was achieved in 96.0% (24/25) and 48.0% (12/25) of patients in the new and conventional method groups, respectively (risk ratio, 2.00; 95% confidence interval [CI], 1.32 to 3.03; risk difference, 48.0%; 95% CI, 27.0% to 69.0%; p<0.001). Adverse events occurred in 4.0% (1/25) and 36.0% (9/25) of patients in the new and conventional method groups, respectively (risk ratio, 0.11; 95% CI, 0.02 to 0.81; risk difference, –32.0%; 95% CI, –52.3% to –11.7%; p=0.005). Conclusions The novel tapered-tip sheath system is a promising option for precisely and safely delivering biopsy forceps to target sites, thereby facilitating the diagnosis of biliary strictures.

Background: Calf muscle circumference is a potential alternative for measuring skeletal muscle mass. However, the association between calf muscle circumference and sarcopenia and the reliability of sarcopenia diagnosis based on calf muscle circumference have not been well reported. In this study, we aimed to determine the usefulness of calf muscle circumference measurement in the diagnosis of sarcopenia. Methods: A cross-sectional study was conducted using data collected from 63 older adults (40 male and 23 female; mean age, 79.7±6.5 years) using day-care rehabilitation. Sarcopenia was defined according to the guidelines of the 2019 Asian Working Group for Sarcopenia (AWGS 2019). The association between sarcopenia and calf muscle circumference was determined using multiple regression analysis, and the reliability of sarcopenia diagnosis based on calf muscle circumference was determined using the kappa coefficient. Results: Overall, 36.5% (30.4% female and 40.0% male) of the participants had sarcopenia. Calf muscle circumference was independently associated with sarcopenia. The best cutoff points for calf muscle circumference to identify older adults at risk of low skeletal muscle mass were 28.7 cm and 31.1 cm for female and male participants, respectively. Furthermore, the kappa coefficient between sarcopenia diagnosed using calf muscle circumference and that diagnosed using the AWGS 2019 criteria was 0.80. Conclusions Calf muscle circumference is independently and significantly associated with sarcopenia in older adults requiring long-term care. Calf muscle circumference is a surrogate for skeletal muscle mass and thus may be used to diagnose sarcopenia.

Objective: To implement early rehabilitation interventions by physical therapists is recommended. However, the effectiveness of early rehabilitation for severe coronavirus disease 2019 (COVID-19) patients in the prevention of post-intensive care syndrome (PICS) is unclear. We analyzed a multicenter prospective observational study (Post-Intensive Care outcomeS in patients with COronaVIrus Disease 2019) to examine the association between early rehabilitation interventions and PICS physical impairment. Methods: An analysis was performed on COVID-19 patients who were admitted to intensive care units (ICUs) between March 2020 and March 2021, and required mechanical ventilation. The primary outcome was the incidence of PICS physical impairment (Barthel Index≤90) after one year. Multivariate logistic regression analysis was used to estimate the association between early rehabilitation interventions and PICS physical impairment by adjusting ICU mobility scale (IMS) during seven-day following ICU admission, and clinically relevant risk factors. Results: The analysis included 259 patients, 54 of whom developed PICS physical impairment one year later. In 81 patients, physical therapists intervened within seven days of ICU admission. There was no significant difference in mean IMS by day seven of admission between the early and non-early rehabilitation patients (0.70 and 0.61, respectively). Multivariate logistic regression analysis showed that early rehabilitation interventions were significantly associated with a low incidence of PICS physical impairment (odds ratio, 0.294; 95% confidence interval, 0.123–0.706; p=0.006). Conclusion Early rehabilitation interventions by physical therapists were an independent factor associated with the decreased development of PICS physical impairment at one year, even though early rehabilitation had no significant effect on IMS.

BACKGROUND: Motion sickness is a common transportation issue worldwide. Vestibular dysfunction has been reported to be a key etiology of motion sickness. However, there are limited technologies for alleviating motion sickness. METHODS: The most appropriate frequency (Hz) and level (dBZ) of pure tone for modulation of vestibular function were determined by an ex vivo study using murine utricle explants. The preventive effects of the selected pure tone on motion sickness were then confirmed by using a beam balance test in mice. The alleviating effects of pure tone on motion sickness induced by a swing, driving simulator or real car were objectively assessed by using posturography and electrocardiography (ECG) and were subjectively assessed by using the Motion Sickness Assessment Questionnaire (MSAQ) in humans. RESULTS: The effect of short-term (≤5 min) exposure to a pure tone of 80-85 dBZ (= 60.9-65.9 dBA) at 100 Hz on motion sickness was investigated in mice and humans. A mouse study showed a long-lasting (≥120 min) alleviative effect on shaking-mediated exacerbated beam test scores by 5-min exposure to a pure tone of 85 dBZ at 100 Hz, which was ex vivo determined as a sound activating vestibular function, before shaking. Human studies further showed that 1-min exposure to a pure tone of 80-85 dBZ (= 60.9-65.9 dBA) at 100 Hz before shaking improved the increased envelope areas in posturography caused by the shakings of a swing, a driving simulator and a vehicle. Driving simulator-mediated activation of sympathetic nerves assessed by the heart rate variable (HRV) and vehicle-mediated increased scores of the MSAQ were improved by pure tone exposure before the shaking. CONCLUSION: Since the exacerbated results of posturography and HRV reflect shaking-mediated imbalance and autonomic dysfunction, respectively, the results suggest that the imbalance and autonomic dysregulation in motion sickness could be improved by just 1-min exposure to a pure tone with daily exposable sound pressure levels. TRIAL REGISTRATION Registration number: UMIN000022413 (2016/05/23-2023/04/19) and UMIN000053735 (2024/02/29-present).
Motion Sickness/therapy* ; Animals ; Mice ; Humans ; Male ; Adult ; Female ; Sound ; Middle Aged ; Young Adult ; Mice, Inbred C57BL

BACKGROUND: Long screen time hours may be associated with behavioral problems in children. To better understand the relationship between children's behavioral problems and screen time, it the associated risk factors must be subdivided based on the purpose underlying screen use. This study examined the relationship between screen time based on intended usage and behavioral problems in Japan. METHODS: This study included 3,332 children aged between 7-17 years from the Hokkaido Study on Environment and Children's Health. From October 2020 to October 2021, the children and their parents answered questionnaires on the children's screen use duration (never used, <30 min, ≥30 min & <1 hour, ≥1 h & <2 h, ≥2 h) based on seven intended usage categories: watching television/video, video gaming, reading books/comics, sending/receiving e-mail/messages, browsing/posting on social networking services, studying for classes/homework, drawing/editing pictures/photos/videos, along with the Strengths and Difficulties Questionnaire (SDQ). Logistic regression was used to analyze the association between screen time, purpose of children's screen use, and behavioral problems across the 13 SDQ total scores. RESULTS: The mean ± standard deviation age of the participants was 12.4 ± 2.4-years-old, 487 (14.6%) children were determined to have behavioral problems, and the duration of screen time increased with their age. The children's primary purposes for screen use were watching television/video, video gaming, sending/receiving e-mail/messages, and browsing/posting on social networking services. Children who reported playing video games for ≥2 hours on weekdays had higher odds of problematic total difficulties scores than never user (Odds Ratio: 2.10, 95% confidence interval: 1.45-3.06). CONCLUSION Long video gaming screen time is associated with behavioral issues, hyperactivity/inattention, and prosocial behaviors in children. Conversely, watching television and videos for 30 min-1 h per day, using e-mail or messaging, and using social networking services were significantly association with reduced odds ratio for peer relationship problems as compared to children who never engaged in these activities. Longitudinal follow-up is needed to further examine screen time and problem behaviors.
Humans ; Screen Time ; Child ; Japan/epidemiology* ; Male ; Female ; Adolescent ; Problem Behavior/psychology* ; Surveys and Questionnaires ; Child Behavior ; Television/statistics & numerical data* ; Video Games/statistics & numerical data*

BACKGROUND: An increased prevalence of cleft lip and/or palate (CL/P), a major congenital anomaly, has been observed in the offspring of women with elevated body mass index (BMI) before pregnancy. Likewise, gestational comorbidities, such as hypertension and diabetes mellitus, also increase the risk of CL/P; however, the risk linked to the coexistence of these conditions in women with higher BMI on birth prevalence of CL/P remains unclear. This study focused on the combined effects of a high BMI before pregnancy and gestational comorbidities on the birth prevalence of CL/P. METHODS: Among 98,373 live births from the Japan Environment and Children's Study (JECS), a nationwide birth cohort, 255 mothers of infants with CL/P (74, 112, and 69 infants born with cleft lip, cleft lip and palate, and isolated cleft palate, respectively) were included in the analyses. The association of CL/P birth prevalence with pre-pregnancy BMI and gestational comorbidities (hypertension and diabetes) was examined using multivariate logistic regression analyses after multiple imputations, with adjustments for several maternal (age at delivery, smoking habits, and alcohol intake) and child-related (sex and prevalence of other congenital diseases) variables, obtained through medical record transcriptions and self-reports on JECS transcription forms. RESULTS: Higher prevalence rates of overweight, gestational hypertension, and gestational diabetes mellitus were found in mothers of infants with CL/P (16.1%, 6.3%, and 4.7%, respectively) than in the control group (10.4%, 3.1%, and 3.1%, respectively). The odds ratio [95% confidence interval] for childbirth with CL/P was increased in mothers with high BMI before pregnancy (1.58 [1.11-2.24]). Furthermore, gestational hypertension and diabetes coexisting with high BMI additionally increased the odds ratios for childbirth with CL/P (2.91 [1.28-6.61] and 2.12 [0.87-5.19], respectively). CONCLUSION High maternal BMI, particularly when accompanied by gestational hypertension, was significantly associated with an increased prevalence of childbirth with CL/P.
Humans ; Female ; Cleft Lip/etiology* ; Cleft Palate/etiology* ; Pregnancy ; Japan/epidemiology* ; Prevalence ; Body Mass Index ; Adult ; Male ; Infant, Newborn ; Comorbidity ; Diabetes, Gestational/epidemiology* ; Risk Factors ; Young Adult ; Birth Cohort

Approximately 60% of pancreatic cancers occur in the pancreatic head and may present as obstructive jaundice due to bile duct invasion. Obstructive jaundice often leads to poor general conditions and acute cholangitis, interfering with surgery and chemotherapy and requiring biliary drainage. The first choice of treatment for biliary drainage is the endoscopic transpapillary approach. In unresectable tumors, self-expandable metal stents (SEMSs) are most commonly used and are classified into uncovered and covered SEMSs. Recently, antireflux metal stents and large- or small-diameter SEMSs have become commercially available, and their usefulness has been reported. Plastic stents are infrequently used in patients with resectable biliary obstruction; however, owing to the recent trend in preoperative chemotherapy, SEMSs are frequently used because of the long time to recurrent biliary obstruction. Endoscopic ultrasound-guided biliary drainage (EUS-BD) is often performed in patients who are not eligible for the transpapillary approach, and favorable outcomes have been reported. Different EUS-BD techniques and specialized stents have been developed and can be safely used in high-volume centers. The indications for EUS-BD are expected to further expand in the future.

Background/Aims: Pathological evaluation is crucial for diagnosing biliary lesions and determining appropriate treatment strategies. However, tissue sampling via the transpapillary route can be difficult. In this study, we aimed to assess the efficacy and safety of a novel tapered-tip sheath system for tissue sampling from biliary strictures. Methods: This single-center, randomized, parallel-group clinical trial included patients aged 20 to 85 years admitted to Kyoto University Hospital for biliary strictures. The patients were randomly assigned (1:1) to a new or conventional method group. The primary outcome was technical success of biopsy at the target bile duct using the assigned method, as determined in accordance with the intention-to-treat principle. Adverse events were assessed in all eligible patients. Results: Fifty-six patients were assessed for eligibility between September 2020 and March 2023; 50 patients were enrolled. The patients were randomly divided into the new (n=25) method group and the conventional (n=25) method group. Technical success was achieved in 96.0% (24/25) and 48.0% (12/25) of patients in the new and conventional method groups, respectively (risk ratio, 2.00; 95% confidence interval [CI], 1.32 to 3.03; risk difference, 48.0%; 95% CI, 27.0% to 69.0%; p<0.001). Adverse events occurred in 4.0% (1/25) and 36.0% (9/25) of patients in the new and conventional method groups, respectively (risk ratio, 0.11; 95% CI, 0.02 to 0.81; risk difference, –32.0%; 95% CI, –52.3% to –11.7%; p=0.005). Conclusions The novel tapered-tip sheath system is a promising option for precisely and safely delivering biopsy forceps to target sites, thereby facilitating the diagnosis of biliary strictures.