1.Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial
Hirokazu OKADA ; Norimitsu UZA ; Tomoaki MATSUMORI ; Hajime YAMAZAKI ; Muneji YASUDA ; Takeshi KUWADA ; Yoshihiro NISHIKAWA ; Takahisa MARUNO ; Masahiro SHIOKAWA ; Atsushi TAKAI ; Ken TAKAHASHI ; Akihisa FUKUDA ; Etsuro HATANO ; Sachiko MINAMIGUCHI ; Hiroshi SENO
Gut and Liver 2025;19(1):136-144
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.
2.Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial
Hirokazu OKADA ; Norimitsu UZA ; Tomoaki MATSUMORI ; Hajime YAMAZAKI ; Muneji YASUDA ; Takeshi KUWADA ; Yoshihiro NISHIKAWA ; Takahisa MARUNO ; Masahiro SHIOKAWA ; Atsushi TAKAI ; Ken TAKAHASHI ; Akihisa FUKUDA ; Etsuro HATANO ; Sachiko MINAMIGUCHI ; Hiroshi SENO
Gut and Liver 2025;19(1):136-144
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.
3.Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial
Hirokazu OKADA ; Norimitsu UZA ; Tomoaki MATSUMORI ; Hajime YAMAZAKI ; Muneji YASUDA ; Takeshi KUWADA ; Yoshihiro NISHIKAWA ; Takahisa MARUNO ; Masahiro SHIOKAWA ; Atsushi TAKAI ; Ken TAKAHASHI ; Akihisa FUKUDA ; Etsuro HATANO ; Sachiko MINAMIGUCHI ; Hiroshi SENO
Gut and Liver 2025;19(1):136-144
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.
4.Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial
Hirokazu OKADA ; Norimitsu UZA ; Tomoaki MATSUMORI ; Hajime YAMAZAKI ; Muneji YASUDA ; Takeshi KUWADA ; Yoshihiro NISHIKAWA ; Takahisa MARUNO ; Masahiro SHIOKAWA ; Atsushi TAKAI ; Ken TAKAHASHI ; Akihisa FUKUDA ; Etsuro HATANO ; Sachiko MINAMIGUCHI ; Hiroshi SENO
Gut and Liver 2025;19(1):136-144
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.
5.The association between employee lifestyles and the rates of mental health-related absenteeism and turnover in Japanese companies
Atsuya FUJIMOTO ; Hiroshi KANEGAE ; Kaori KITAOKA ; Mizuki OHASHI ; Kunio OKADA ; Koichi NODE ; Kenkichi TAKASE ; Hiroshi FUKUDA ; Tomoyuki MIYAZAKI ; Yuichiro YANO
Epidemiology and Health 2024;46(1):e2024068-
We assessed the association of employee lifestyles (e.g., smoking, exercise, drinking, and sleep habits) with mental health-related absenteeism and turnover rates utilizing data from the annual Health and Productivity Management survey by Japan’s Ministry of Economy, Trade and Industry. This analysis included data from 1,748 companies, encompassing 4,199,021 employees. The average proportions of mental health-related absenteeism and employee turnover rates were 1.1±1.0% and 5.0±5.0%, respectively. In multivariable regression models that incorporated all lifestyle factors and confounders, a 1 percentage point increase in the proportion of employees who slept well was associated with reductions in their turnover rate (mean, -0.020%; 95% confidence interval [CI], -0.038 to -0.002) and in mental health-related absenteeism (mean, -0.005%; 95% CI, -0.009 to 0.001). A similar increase in the proportion of employees engaging in regular physical activity corresponded with a 0.005% decrease in the prevalence of mental health-related absenteeism (95% CI, -0.010 to -0.001). A 1 percentage point increase in the proportion of employees who smoked was associated with a 0.013% reduction in mental health-related absenteeism (95% CI, -0.017 to -0.008). Nonetheless, the current study’s observational and cross-sectional design restricted the ability to establish causality between employee lifestyle factors and mental health issues.
6.The association between employee lifestyles and the rates of mental health-related absenteeism and turnover in Japanese companies
Atsuya FUJIMOTO ; Hiroshi KANEGAE ; Kaori KITAOKA ; Mizuki OHASHI ; Kunio OKADA ; Koichi NODE ; Kenkichi TAKASE ; Hiroshi FUKUDA ; Tomoyuki MIYAZAKI ; Yuichiro YANO
Epidemiology and Health 2024;46(1):e2024068-
We assessed the association of employee lifestyles (e.g., smoking, exercise, drinking, and sleep habits) with mental health-related absenteeism and turnover rates utilizing data from the annual Health and Productivity Management survey by Japan’s Ministry of Economy, Trade and Industry. This analysis included data from 1,748 companies, encompassing 4,199,021 employees. The average proportions of mental health-related absenteeism and employee turnover rates were 1.1±1.0% and 5.0±5.0%, respectively. In multivariable regression models that incorporated all lifestyle factors and confounders, a 1 percentage point increase in the proportion of employees who slept well was associated with reductions in their turnover rate (mean, -0.020%; 95% confidence interval [CI], -0.038 to -0.002) and in mental health-related absenteeism (mean, -0.005%; 95% CI, -0.009 to 0.001). A similar increase in the proportion of employees engaging in regular physical activity corresponded with a 0.005% decrease in the prevalence of mental health-related absenteeism (95% CI, -0.010 to -0.001). A 1 percentage point increase in the proportion of employees who smoked was associated with a 0.013% reduction in mental health-related absenteeism (95% CI, -0.017 to -0.008). Nonetheless, the current study’s observational and cross-sectional design restricted the ability to establish causality between employee lifestyle factors and mental health issues.
7.The association between employee lifestyles and the rates of mental health-related absenteeism and turnover in Japanese companies
Atsuya FUJIMOTO ; Hiroshi KANEGAE ; Kaori KITAOKA ; Mizuki OHASHI ; Kunio OKADA ; Koichi NODE ; Kenkichi TAKASE ; Hiroshi FUKUDA ; Tomoyuki MIYAZAKI ; Yuichiro YANO
Epidemiology and Health 2024;46(1):e2024068-
We assessed the association of employee lifestyles (e.g., smoking, exercise, drinking, and sleep habits) with mental health-related absenteeism and turnover rates utilizing data from the annual Health and Productivity Management survey by Japan’s Ministry of Economy, Trade and Industry. This analysis included data from 1,748 companies, encompassing 4,199,021 employees. The average proportions of mental health-related absenteeism and employee turnover rates were 1.1±1.0% and 5.0±5.0%, respectively. In multivariable regression models that incorporated all lifestyle factors and confounders, a 1 percentage point increase in the proportion of employees who slept well was associated with reductions in their turnover rate (mean, -0.020%; 95% confidence interval [CI], -0.038 to -0.002) and in mental health-related absenteeism (mean, -0.005%; 95% CI, -0.009 to 0.001). A similar increase in the proportion of employees engaging in regular physical activity corresponded with a 0.005% decrease in the prevalence of mental health-related absenteeism (95% CI, -0.010 to -0.001). A 1 percentage point increase in the proportion of employees who smoked was associated with a 0.013% reduction in mental health-related absenteeism (95% CI, -0.017 to -0.008). Nonetheless, the current study’s observational and cross-sectional design restricted the ability to establish causality between employee lifestyle factors and mental health issues.
8.The association between employee lifestyles and the rates of mental health-related absenteeism and turnover in Japanese companies
Atsuya FUJIMOTO ; Hiroshi KANEGAE ; Kaori KITAOKA ; Mizuki OHASHI ; Kunio OKADA ; Koichi NODE ; Kenkichi TAKASE ; Hiroshi FUKUDA ; Tomoyuki MIYAZAKI ; Yuichiro YANO
Epidemiology and Health 2024;46(1):e2024068-
We assessed the association of employee lifestyles (e.g., smoking, exercise, drinking, and sleep habits) with mental health-related absenteeism and turnover rates utilizing data from the annual Health and Productivity Management survey by Japan’s Ministry of Economy, Trade and Industry. This analysis included data from 1,748 companies, encompassing 4,199,021 employees. The average proportions of mental health-related absenteeism and employee turnover rates were 1.1±1.0% and 5.0±5.0%, respectively. In multivariable regression models that incorporated all lifestyle factors and confounders, a 1 percentage point increase in the proportion of employees who slept well was associated with reductions in their turnover rate (mean, -0.020%; 95% confidence interval [CI], -0.038 to -0.002) and in mental health-related absenteeism (mean, -0.005%; 95% CI, -0.009 to 0.001). A similar increase in the proportion of employees engaging in regular physical activity corresponded with a 0.005% decrease in the prevalence of mental health-related absenteeism (95% CI, -0.010 to -0.001). A 1 percentage point increase in the proportion of employees who smoked was associated with a 0.013% reduction in mental health-related absenteeism (95% CI, -0.017 to -0.008). Nonetheless, the current study’s observational and cross-sectional design restricted the ability to establish causality between employee lifestyle factors and mental health issues.
9.Development of Dilated Esophagus, Sigmoid Esophagus, and Esophageal Diverticulum in Patients With Achalasia: Japan Achalasia Multicenter Study
Hiroki SATO ; Yusuke FUJIYOSHI ; Hirofumi ABE ; Hironari SHIWAKU ; Junya SHIOTA ; Chiaki SATO ; Hiroyuki SAKAE ; Masaki OMINAMI ; Yoshitaka HATA ; Hisashi FUKUDA ; Ryo OGAWA ; Jun NAKAMURA ; Tetsuya TATSUTA ; Yuichiro IKEBUCHI ; Hiroshi YOKOMICHI ; Shuji TERAI ; Haruhiro INOUE
Journal of Neurogastroenterology and Motility 2022;28(2):222-230
Background/Aims:
Patients with achalasia-related esophageal motility disorders (AEMDs) frequently present with dilated and sigmoid esophagus, anddevelop esophageal diverticulum (ED), although the prevalence and patients characteristics require further elucidation.
Methods:
We conducted a multicenter cohort study of 3707 patients with AEMDs from 14 facilities in Japan. Esophagography on 3682 patients were analyzed.
Results:
Straight (n = 2798), sigmoid (n = 684), and advanced sigmoid esophagus (n = 200) were diagnosed. Multivariate analysis revealed that long disease duration, advanced age, obesity, and type I achalasia correlate positively, whereas severe symptoms and integrated relaxation pressure correlate negatively with development of sigmoid esophagus. In contrast, Grade II dilation (3.5-6.0 cm) was the most common (52.9%), while grade III dilation (≥ 6 cm) was rare (5.0%). We found early onset, male, obesity, and type I achalasia correlated positively, while advanced age correlated negatively with esophageal dilation. Dilated and sigmoid esophagus were found mostly in types I and II achalasia, but typically not found in spastic disorders. The prevalence of ED was low (n = 63, 1.7%), and non-dilated esophagus and advanced age correlated with ED development. Patients with right-sided ED (n = 35) had a long disease duration (P = 0.005) with low integrated relaxation pressure values (P = 0.008) compared with patients with left-sided ED (n = 22). Patients with multiple EDs (n = 6) had lower symptom severity than patients with a single ED (P = 0.022).
Conclusions
The etiologies of dilated esophagus, sigmoid esophagus, and ED are considered multifactorial and different. Early diagnosis and optimal treatment of AEMDs are necessary to prevent these conditions.
10.Subtype of Achalasia and Integrated Relaxation Pressure Measured Using the Starlet High-resolution Manometry System: A Multicenter Study in Japan
Tetsuya TATSUTA ; Hiroki SATO ; Yusuke FUJIYOSHI ; Hirofumi ABE ; Akio SHIWAKU ; Junya SHIOTA ; Chiaki SATO ; Masaki OMINAMI ; Yoshitaka HATA ; Hisashi FUKUDA ; Ryo OGAWA ; Jun NAKAMURA ; Yuichiro IKEBUCHI ; Hiroshi YOKOMICHI ; Shinsaku FUKUDA ; Haruhiro INOUE
Journal of Neurogastroenterology and Motility 2022;28(4):562-571
Background/Aims:
ManoScan and Sandhill high-resolution manometry (HRM) systems are used worldwide; however, the diagnosis of achalasia on the Starlet HRM system is not fully characterized. Furthermore, the impact of calcium channel blockers and nitrites in treating achalasia has not been investigated using HRM. Management of recurrent cases is a priority issue, although few studies have examined patient characteristics.
Methods:
We conducted a multicenter, large-scale database analysis. First, the diagnosis of treatment-naive achalasia in each HRM system was investigated. Next, patient characteristics were compared between type I-III achalasia, and the impact of patient characteristics, including calcium channel blocker and nitrite use for integrated relaxation pressure (IRP) values, were analyzed. Finally, patient characteristics with recurrent achalasia were elucidated.
Results:
The frequency of type I achalasia with Starlet was significantly higher than that with ManoScan and Sandhill HRM systems. In achalasia, multivariate analysis identified male sex, advanced age, long disease duration, obesity, type I achalasia, and sigmoid type as risk factors related to normal IRP values (< 26 mmHg). Calcium channel blockers and nitrites use had no significant impact on the IRP values, although achalasia symptoms were indicated to be alleviated. In recurrent cases, the IRP value was significantly lower, and advanced age, long disease duration, and sigmoid type were more common than in treatment-naive patients.
Conclusions
We should cautiously interpret the type of achalasia and IRP values in the Starlet HRM system. Symptoms of recurrent cases are related to disease progression rather than IRP values, which should be considered in decision making.

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