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.Hokkaido birth cohort study on environment and children's health: cohort profile 2021.
Reiko KISHI ; Atsuko IKEDA-ARAKI ; Chihiro MIYASHITA ; Sachiko ITOH ; Sumitaka KOBAYASHI ; Yu AIT BAMAI ; Keiko YAMAZAKI ; Naomi TAMURA ; Machiko MINATOYA ; Rahel Mesfin KETEMA ; Kritika POUDEL ; Ryu MIURA ; Hideyuki MASUDA ; Mariko ITOH ; Takeshi YAMAGUCHI ; Hisanori FUKUNAGA ; Kumiko ITO ; Houman GOUDARZI
Environmental Health and Preventive Medicine 2021;26(1):59-59
BACKGROUND:
The Hokkaido Study on Environment and Children's Health is an ongoing study consisting of two birth cohorts of different population sizes: the Sapporo cohort and the Hokkaido cohort. Our primary objectives are to (1) examine the effects that low-level environmental chemical exposures have on birth outcomes, including birth defects and growth retardation; (2) follow the development of allergies, infectious diseases, and neurobehavioral developmental disorders, as well as perform a longitudinal observation of child development; (3) identify high-risk groups based on genetic susceptibility to environmental chemicals; and (4) identify the additive effects of various chemicals, including tobacco.
METHODS:
The purpose of this report is to provide an update on the progress of the Hokkaido Study, summarize recent results, and suggest future directions. In particular, this report provides the latest details from questionnaire surveys, face-to-face examinations, and a collection of biological specimens from children and measurements of their chemical exposures.
RESULTS:
The latest findings indicate different risk factors of parental characteristics on birth outcomes and the mediating effect between socioeconomic status and children that are small for the gestational age. Maternal serum folate was not associated with birth defects. Prenatal chemical exposure and smoking were associated with birth size and growth, as well as cord blood biomarkers, such as adiponectin, leptin, thyroid, and reproductive hormones. We also found significant associations between the chemical levels and neuro development, asthma, and allergies.
CONCLUSIONS
Chemical exposure to children can occur both before and after birth. Longer follow-up for children is crucial in birth cohort studies to reinforce the Developmental Origins of Health and Disease hypothesis. In contrast, considering shifts in the exposure levels due to regulation is also essential, which may also change the association to health outcomes. This study found that individual susceptibility to adverse health effects depends on the genotype. Epigenome modification of DNA methylation was also discovered, indicating the necessity of examining molecular biology perspectives. International collaborations can add a new dimension to the current knowledge and provide novel discoveries in the future.
Biomarkers/blood*
;
Child
;
Child Health
;
Child, Preschool
;
Cohort Studies
;
Environmental Exposure/adverse effects*
;
Environmental Health
;
Environmental Pollutants/adverse effects*
;
Female
;
Fetal Blood/chemistry*
;
Follow-Up Studies
;
Growth/drug effects*
;
Humans
;
Hypersensitivity/etiology*
;
Infant
;
Japan/epidemiology*
;
Male
;
Neurodevelopmental Disorders/etiology*
;
Pregnancy
;
Prenatal Exposure Delayed Effects/etiology*
;
Prevalence
;
Smoking/adverse effects*
6.Prenatal tobacco exposure and ADHD symptoms at pre-school age: the Hokkaido Study on Environment and Children's Health.
Machiko MINATOYA ; Atsuko ARAKI ; Sachiko ITOH ; Keiko YAMAZAKI ; Sumitaka KOBAYASHI ; Chihiro MIYASHITA ; Seiko SASAKI ; Reiko KISHI
Environmental Health and Preventive Medicine 2019;24(1):74-74
BACKGROUND:
There have been inconsistent findings reported on maternal passive smoking during pregnancy and child risk of ADHD. In this study, ADHD symptoms at pre-school age children in association with prenatal passive and active tobacco smoke exposure determined by maternal plasma cotinine levels in the third trimester were investigated.
METHODS:
This was a follow-up study of the birth cohort: the Hokkaido Study on Environment and Children's Health. Children whose parents answered Strengths and Difficulties Questionnaire (SDQ) to identify child ADHD symptoms (hyperactivity/inattention and conduct problems) and total difficulties at age 5 years with available maternal plasma cotinine level at the third trimester were included (n = 3216). Cotinine levels were categorized into 4 groups; ≦ 0.21 ng/ml (non-smoker), 0.22-0.51 ng/ml (low-passive smoker), 0.52-11.48 ng/ml (high-passive smoker), and ≧ 11.49 ng/ml (active smoker).
RESULTS:
Maternal cotinine levels of active smokers were significantly associated with an increased risk of total difficulties (OR = 1.67) and maternal low- and high-passive smoking also increased the risk (OR = 1.11, 1.25, respectively) without statistical significance. Similarly, maternal cotinine levels of active smokers were associated with an increased risk of hyperactivity/inattention (OR = 1.49). Maternal low- and high-passive smoking and active smoking increased the risk of hyperactivity/inattention (OR = 1.45, 1.43, and OR = 1.59, respectively) only in boys.
CONCLUSION
Our findings suggested that maternal active smoking during pregnancy may contribute to the increased risk of child total difficulties and hyperactivity/inattention at pre-school age. Pregnant women should be encouraged to quit smoking and avoid exposure to tobacco smoke.
Adult
;
Attention Deficit Disorder with Hyperactivity
;
epidemiology
;
etiology
;
physiopathology
;
psychology
;
Child, Preschool
;
Cotinine
;
blood
;
Female
;
Follow-Up Studies
;
Humans
;
Japan
;
epidemiology
;
Male
;
Maternal Exposure
;
adverse effects
;
Mothers
;
Pregnancy
;
Pregnancy Trimester, Third
;
Prenatal Exposure Delayed Effects
;
epidemiology
;
etiology
;
Risk
;
Sex Factors
;
Tobacco Smoking
;
adverse effects
;
epidemiology
7.Prenatal exposure to bisphenol A and phthalates and behavioral problems in children at preschool age: the Hokkaido Study on Environment and Children's Health.
Machiko MINATOYA ; Sachiko ITOH ; Keiko YAMAZAKI ; Atsuko ARAKI ; Chihiro MIYASHITA ; Naomi TAMURA ; Jun YAMAMOTO ; Yu ONODA ; Kazuki OGASAWARA ; Toru MATSUMURA ; Reiko KISHI
Environmental Health and Preventive Medicine 2018;23(1):43-43
BACKGROUND:
Studies reported adverse behavioral development including internalizing and externalizing problems in association with prenatal exposure to bisphenol A (BPA) and phthalates; however, findings were not sufficient due to using different assessment tools and child ages among studies. This study aimed to examine associations between maternal serum levels of BPA and phthalate metabolites and behavioral problems at preschool age.
METHODS:
The Strengths and Difficulties Questionnaire (SDQ) was used to assess behavioral problems at 5 years of age. BPA and phthalate metabolite levels in the first trimester maternal serum was determined by LC-MS/MS for 458 children. Variables used for adjustment were parental ages, maternal cotinine levels, family income during pregnancy, child sex, birth order, and age at SDQ completed.
RESULTS:
The median concentrations of BPA, MnBP, MiBP, MEHP, and MECPP, primary and secondary metabolites of phthalates, were 0.062, 26.0, 7.0, 1.40, and 0.20 ng/ml, respectively. MECPP level was associated with increase conduct problem risk (OR = 2.78, 95% CI 1.36-5.68) overall and the association remained after child sex stratification, and odds ratios were increased with wider confidence interval (OR = 2.85, 95% CI 1.07-7.57 for boys, OR = 4.04, 95% CI 1.31-12.5 for girls, respectively). BPA, ∑DBP (MnBP + MiBP), and ∑DEHP (MEHP+MECPP) levels were not associated with any of the child behavioral problems.
CONCLUSIONS
Our analyses found no significant association between BPA or summation of phthalate metabolite levels and any of the behavioral problems at 5 years of age but suggested possible association between MECPP levels and increased risk of conduct problems.
Adult
;
Age Factors
;
Benzhydryl Compounds
;
blood
;
Child, Preschool
;
Environmental Exposure
;
analysis
;
Female
;
Humans
;
Male
;
Phenols
;
blood
;
Phthalic Acids
;
blood
;
Pregnancy
;
Prenatal Exposure Delayed Effects
;
epidemiology
;
Problem Behavior
;
Smoking
;
epidemiology
;
Socioeconomic Factors
8.Acute Heart Failure due to Noncoronary Sinus of Valsalva Aneurysm with Rupture into the Right Atrium
Takaaki Samura ; Yasushi Tsutsumi ; Osamu Monta ; Satoshi Numata ; Sachiko Yamazaki ; Hisazumi Uenaka ; Takashi Shirakawa ; Syusaku Maeda ; Hirokazu Ohashi
Japanese Journal of Cardiovascular Surgery 2015;44(3):144-147
A 65-year-old woman was referred for progressive dyspnea and leg edema. Physical examination revealed a continuous murmur along the right sternal border. Enhanced computed tomography showed an aneurysm that extended to the right atrium. Aortic angiography confirmed the rupture of the valsalva aneurysm into the right atrium. The patient underwent emergency surgery to close the aneurysm ostium and suture closure of the right atrial fistula. The patient's postoperative course was uneventful.
9.A Case of Early Limb Stenosis after Endovascular Abdominal Aneurysm Repair with the Endurant Stent Graft System
Tsunehisa Yamamoto ; Katsuhiko Oka ; Osamu Sakai ; Hidetake Kawajiri ; Sachiko Yamazaki ; Taiji Watanabe ; Keiichi Kanda ; Hitoshi Yaku
Japanese Journal of Cardiovascular Surgery 2015;44(5):283-287
An 81-year-old man who had a saccular abdominal aortic aneurysm (AAA) with a narrow terminal aorta underwent endovascular aortic aneurysm repair (EVAR) with the Medtronic Endurant® stent graft system. After 4 days, computed tomography (CT) showed stenosis of the stent graft left limb, which was pressed flat against the right limb at the narrow terminal aorta. We performed re-intervention to dilate the narrow terminal aorta and bilateral limbs with kissing stenting using Express Vascular LD® (Boston Scientific). After operation his ankle brachial pressure index rose from 0.88 to 0.99 and there was no evidence of stenotic limbs at CT image. We need to be careful about the stenotic limb after EVAR with Medtronic Endurant stentgraft system for AAA with a narrow terminal aorta.
10.Early Results of Endoscopic Saphenous Vein Harvesting in Coronary Artery Bypass Grafting
Hiroyuki Seo ; Yasushi Tsutsumi ; Osamu Monta ; Satoshi Numata ; Sachiko Yamazaki ; Shohei Yoshida ; Hirokazu Ohashi
Japanese Journal of Cardiovascular Surgery 2013;42(5):364-368
Recently, with the advent of medical devices and minimally invasive operations, endoscopic saphenous vein harvesting (EVH) in coronary artery bypass grafting has been widely accepted. Although EVH has short-term advantages of less wound morbidity and better cosmetic results compared with open vein harvesting (OVH), several studies have demonstrated that the mid- and long-term patency rate of EVH veins is significantly lower than that of OVH veins, therefore the role of EVH is currently controversial. The purpose of this study was to investigate the early results of EVH compared with the OVH group. Between April 2011 and December 2012, 115 consecutive patients underwent coronary artery bypass grafting (CABG) in our institution. Of these, EVH was performed in 62 patients and OVH in 53. In EVH groups, all 50 patients were men, and mean age was 71.3±7.8 years. A total of 211 coronary anastomoses, 109 SVGs anastomoses were assessed for patency postoperatively by angiography or enhanced computed tomography before discharge. The mean vein harvesting time was 26.0±8.1 min, and the mean number of ostial branch tear was 0.34±0.59. The overall SVG patency rates at discharge were 95.4% in EVH and 92% in OVH, respectively (p=0.24). There was a significant reduction in the incidence of leg wound complications in the EVH group (EVH : 1.6% ; OVH : 13.2% ; p=0.038). In conclusion, the short-term result of EVH was satisfactory. EVH reduces leg wound complications compared with OVH.


Result Analysis
Print
Save
E-mail