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.Effective Multidisciplinary Collaboration Involving Rehabilitation Treatment, Nutrition, and Medication Management for Patients with Parkinson Disease with Fatigue and Dysautonomia:A Case Report
Keisuke YASUDA ; Syuuichirou SUZUKI ; Keigo OKUYAMA ; Youko HATANAKA ; Yuri KASHIWAGI ; Masahiro AOKI
The Japanese Journal of Rehabilitation Medicine 2024;():23053-
Introduction:Here we report the case of a patient with Parkinson disease (PD) who showed improved physical function and non-motor symptoms, including fatigue and dysautonomia, through a multidisciplinary collaboration involving rehabilitation treatment, nutrition, and medication management.Case:A 77-year-old woman with PD was hospitalized for condition assessment and environmental adjustments and complained of fatigue and dizziness. She presented with decreased physical function, sarcopenia, orthostatic hypotension, and an impaired circulatory response during exercise. A multidisciplinary conference was conducted to address these issues, and we decided to implement rehabilitation treatment, nutrition, and medication management.The rehabilitation program consisted of 1 h/day physiotherapy sessions involving stretching exercises, muscle-strengthening exercises, and walking training. Because she often made medication administration errors, a nurse managed them on her behalf. Nutrition management was established to ensure sufficient energy for her total energy expenditure.At discharge, a notable improvement was recorded in Part 1 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale, and the patient's complaints of fatigue and dizziness had subsided. Additionally, physical function measures such as skeletal muscle mass, comfortable walking speed over a 10-m distance, 6-min walking distance, and Berg Balance Scale score improved. To optimize the patient's home environment, home nursing, home-visit rehabilitation, and meal delivery services were introduced to manage her medication and nutritional needs.Discussion:In addition to rehabilitation treatment, the reconsideration of a patient's daily living activities, such as taking medications and meals, is important for improving their physical function and non-motor symptoms including fatigue and dysautonomia.
6.Effective Multidisciplinary Collaboration Involving Rehabilitation Treatment, Nutrition, and Medication Management for Patients with Parkinson Disease with Fatigue and Dysautonomia:A Case Report
Keisuke YASUDA ; Syuuichirou SUZUKI ; Keigo OKUYAMA ; Youko HATANAKA ; Yuri KASHIWAGI ; Masahiro AOKI
The Japanese Journal of Rehabilitation Medicine 2024;61(6):548-554
Introduction:Here we report the case of a patient with Parkinson disease (PD) who showed improved physical function and non-motor symptoms, including fatigue and dysautonomia, through a multidisciplinary collaboration involving rehabilitation treatment, nutrition, and medication management.Case:A 77-year-old woman with PD was hospitalized for condition assessment and environmental adjustments and complained of fatigue and dizziness. She presented with decreased physical function, sarcopenia, orthostatic hypotension, and an impaired circulatory response during exercise. A multidisciplinary conference was conducted to address these issues, and we decided to implement rehabilitation treatment, nutrition, and medication management.The rehabilitation program consisted of 1 h/day physiotherapy sessions involving stretching exercises, muscle-strengthening exercises, and walking training. Because she often made medication administration errors, a nurse managed them on her behalf. Nutrition management was established to ensure sufficient energy for her total energy expenditure.At discharge, a notable improvement was recorded in Part 1 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale, and the patient's complaints of fatigue and dizziness had subsided. Additionally, physical function measures such as skeletal muscle mass, comfortable walking speed over a 10-m distance, 6-min walking distance, and Berg Balance Scale score improved. To optimize the patient's home environment, home nursing, home-visit rehabilitation, and meal delivery services were introduced to manage her medication and nutritional needs.Discussion:In addition to rehabilitation treatment, the reconsideration of a patient's daily living activities, such as taking medications and meals, is important for improving their physical function and non-motor symptoms including fatigue and dysautonomia.
7.Evaluation of Pharmaceutical Characteristics and Carer Usability of Antiglaucoma Ophthalmic Solutions
Rika TANAKA ; Masahiro MURAKAMI ; Megumi YASUDA ; Manabu AMANO
Japanese Journal of Drug Informatics 2020;22(3):147-152
Objective: Glaucoma is the most frequent cause of blindness in Japan and is primarily treated using IOP-lowering ophthalmic solutions. Although the patients themselves frequently instill ophthalmic solutions, instillation by caregivers may be necessary for various reasons. Therefore, we evaluated pharmaceutical characteristics of antiglaucoma ophthalmic solutions and their usability from the caregivers' viewpoint.Methods: Five dorzolamide hydrochloride-timolol maleate ophthalmic solutions and 2 travoprost-timolol maleate ophthalmic solutions were evaluated concerning the pharmaceutical characteristics and subjective squeezability rated by adults aged 20 years or above.Results: Among the dorzolamide hydrochloride-timolol maleate compounding ophthalmic solutions, the squeeze force was the lowest in COSOPT® ophthalmic solution (11.8 N), and DORMOLOL® combination ophthalmic solution NITTEN was rated highest, with 68.2% of the subjects placing it within the top 3 levels of a 7-level scale. Of the travoprost-timolol maleate ophthalmic solutions, the squeeze force was 9.8 N, lower than the pioneer drug, in TraTimo® combination ophthalmic solution NITTO, which was also rated in the top 3 levels by 90.3% of the subjects. A strong negative correlation was observed between the squeeze force and squeezability.Conclusion: In instillation by caregivers, the squeeze force was shown to be correlated with subjective squeezability as in instillation by patients themselves. This study provided information concerning the usability of ophthalmic solutions from the caregivers' viewpoint. For the future, it is necessary to select ophthalmic solutions from the caregivers' as well as the patients' viewpoints by utilizing information obtained in this study.
8.Comparative Evaluation of the Pharmaceutical Properties of Original and Generic Betamethasone Ophthalmic Solution
Masahiro MURAKAMI ; Chihiro OHTA ; Megumi YASUDA ; Manabu AMANO
Japanese Journal of Drug Informatics 2019;20(4):227-231
Objective: In this study, pharmaceutical properties were compared between the original and generic ophthalmic solutions containing betamethasone.Methods: The squeeze force, drop weight, surface tension, pH, kinematic viscosity, and total number of drops were measured. The drop volume was calculated from the drop weight and specific gravity. Information on preservatives contained in each product was collected from package inserts.Results: There was a significant difference in the squeeze force between the original and generic drugs. The pH and kinematic viscosity did not differ between the drugs. The drop volume was in the range of 30.3 to 47.2 μL, and the surface tension ranged between 33.7 and 65.2 mN/N. The total number of drops was approximately 100 in the original drug, being the lowest.Conclusion: The results of this study showed that the squeeze forces of all generic products but RINBETA PF, which was contained in a specific container, were smaller than that of the original product. The drop volumes of 2 generic products were ≥ 15-μL smaller than that of the original product, but they were within the permissible range. The maximum difference in the surface tension was approximately 33 mN/N, suggesting that drug solution relatively frequently overflows from the eyes. The total number of drops for all generic products was greater than that for the original product, suggesting that the former can be used at a higher frequency. Based on these results, pharmacists must select products in accordance with individual patients.
9.Infectious peritonitis after endoscopic ultrasound-guided biliary drainage in a patient with ascites
Nozomi OKUNO ; Kazuo HARA ; Nobumasa MIZUNO ; Takamichi KUWAHARA ; Hiromichi IWAYA ; Masahiro TAJIKA ; Tsutomu TANAKA ; Makoto ISHIHARA ; Yutaka HIRAYAMA ; Sachiyo ONISHI ; Kazuhiro TORIYAMA ; Ayako ITO ; Naosuke KURAOKA ; Shimpei MATSUMOTO ; Masahiro OBATA ; Muneji YASUDA ; Yusuke KURITA ; Hiroki TANAKA ; Yasumasa NIWA
Gastrointestinal Intervention 2018;7(1):40-43
SUMMARY OF EVENT: Bacterial, mycotic peritonitis and Candida fungemia developed in a patient with moderate ascites who had undergone endoscopic ultrasound-guided biliary drainage (EUS-BD). Antibiotics and antifungal agent were administered and ascites drainage was performed. Although the infection improved, the patient's general condition gradually deteriorated due to aggravation of the primary cancer and he died. TEACHING POINT: This is the first report to describe infectious peritonitis after EUS-BD. Ascites carries the potential risk of severe complications. As such, in patients with ascites, endoscopic retrograde cholangiopancreatography (ERCP) is typically preferred over EUS-BD or percutaneous drainage to prevent bile leakage. However, ERCP may not be possible in some patients with tumor invasion of the duodenum or with surgically altered anatomy. Thus, in patients with ascites who require EUS-BD, we recommend inserting the drainage tube percutaneously and draining the ascites before and after the intervention in order to prevent severe infection.
Anti-Bacterial Agents
;
Ascites
;
Bile
;
Candida
;
Cholangiopancreatography, Endoscopic Retrograde
;
Drainage
;
Duodenum
;
Endosonography
;
Fungemia
;
Humans
;
Peritonitis
10.Guanylyl cyclase C and guanylin reduce fat droplet accumulation in cattle mesenteric adipose tissue.
Masahiro YASUDA ; Jyunya KAWABATA ; Sayaka AKIEDA-ASAI ; Tetsuo NASU ; Yukari DATE
Journal of Veterinary Science 2017;18(3):341-348
Guanylyl cyclase C (GC-C) is a member of a family of enzymes that metabolize GTP to cGMP and was first identified as a receptor for heat-stable enterotoxin. Guanylin (GNY) has since been identified as an endogenous ligand for GC-C in the intestine of several mammalian species. The GNY/GC-C system regulates ion transportation and pH in the mucosa. Recently, it was reported that GC-C and GNY are involved in lipid metabolism in rat mesenteric adipose tissue macrophages. To examine the role of GC-C and GNY in lipid metabolism in cattle, we used a bovine mesenteric adipocyte primary culture system and a coculture system for bovine adipocytes and GNY-/GC-C-expressing macrophages. Fat droplets were observed to accumulate in bovine mesenteric adipocytes cultured alone, whereas few fat droplets accumulated in adipocytes indirectly cocultured with macrophages. We also observed that GC-C was present in bovine mesenteric adipose tissue, and that fat droplet accumulation decreased after in vitro GNY administration. Expressions of mRNAs encoding lipogenic factors decreased significantly in adipocytes after either coculture or GNY administration. These results suggest that the GNY/GC-C system is part of the control system for lipid accumulation in bovine mesenteric adipose tissue.
Adipocytes
;
Adipose Tissue*
;
Animals
;
Cattle*
;
Coculture Techniques
;
Enterotoxins
;
Guanosine Triphosphate
;
Guanylate Cyclase*
;
Humans
;
Hydrogen-Ion Concentration
;
In Vitro Techniques
;
Intestines
;
Ion Transport
;
Lipid Metabolism
;
Macrophages
;
Mucous Membrane
;
Rats
;
RNA, Messenger


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