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.Impact of Japan’s Revised Infectious Disease Control Law on Older Adults’ Social Life during the COVID-19 Pandemic
Kohji IWAI ; Yuta KUBO ; Takeshi YAMAZAKI ; Takahiro HAYASHI
Annals of Geriatric Medicine and Research 2025;29(1):53-57
Background:
In May 2023, Japan reclassified coronavirus disease 2019 (COVID-19) under the Infectious Disease Control Law. However, there have been insufficient examinations on how the change in classification has impacted citizens’ lives. This study examined the impact of revisions to the Infectious Disease Control Law in Japan on the social frailty and social life of older adults in the community.
Methods:
From mid-March to mid-April 2023, a self-administered survey targeting community-dwelling older adults aged 65 years and over was conducted by mail, before the revision of the Infectious Disease Control Law. From mid-February to mid-March 2024, after the revision of the law, a second survey was conducted among those who had responded to the first one. Ultimately, data from 240 cases were collected. The survey included social information such as mask-wearing when going out, status of long-term care insurance, presence of polypharmacy, sleep status, long outings, presence of COVID-19 infection, presence of post-COVID-19 syndrome (if infected), social frailty, and the Kihon Checklist, alongside basic demographic information.
Results:
After the revision of the Infectious Disease Control Law, there was an increase in the number of individuals receiving benefits from long-term care insurance and those identified as socially frail. However, no significant differences were observed in the other surveyed items.
Conclusion
The increase in socially frail individuals and those with long-term care insurance suggests that, despite the revision of the Infectious Disease Control Law, the connections within the local community that had once weakened due to the COVID-19 pandemic have not been fully restored.
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.Impact of Japan’s Revised Infectious Disease Control Law on Older Adults’ Social Life during the COVID-19 Pandemic
Kohji IWAI ; Yuta KUBO ; Takeshi YAMAZAKI ; Takahiro HAYASHI
Annals of Geriatric Medicine and Research 2025;29(1):53-57
Background:
In May 2023, Japan reclassified coronavirus disease 2019 (COVID-19) under the Infectious Disease Control Law. However, there have been insufficient examinations on how the change in classification has impacted citizens’ lives. This study examined the impact of revisions to the Infectious Disease Control Law in Japan on the social frailty and social life of older adults in the community.
Methods:
From mid-March to mid-April 2023, a self-administered survey targeting community-dwelling older adults aged 65 years and over was conducted by mail, before the revision of the Infectious Disease Control Law. From mid-February to mid-March 2024, after the revision of the law, a second survey was conducted among those who had responded to the first one. Ultimately, data from 240 cases were collected. The survey included social information such as mask-wearing when going out, status of long-term care insurance, presence of polypharmacy, sleep status, long outings, presence of COVID-19 infection, presence of post-COVID-19 syndrome (if infected), social frailty, and the Kihon Checklist, alongside basic demographic information.
Results:
After the revision of the Infectious Disease Control Law, there was an increase in the number of individuals receiving benefits from long-term care insurance and those identified as socially frail. However, no significant differences were observed in the other surveyed items.
Conclusion
The increase in socially frail individuals and those with long-term care insurance suggests that, despite the revision of the Infectious Disease Control Law, the connections within the local community that had once weakened due to the COVID-19 pandemic have not been fully restored.
6.Impact of Japan’s Revised Infectious Disease Control Law on Older Adults’ Social Life during the COVID-19 Pandemic
Kohji IWAI ; Yuta KUBO ; Takeshi YAMAZAKI ; Takahiro HAYASHI
Annals of Geriatric Medicine and Research 2025;29(1):53-57
Background:
In May 2023, Japan reclassified coronavirus disease 2019 (COVID-19) under the Infectious Disease Control Law. However, there have been insufficient examinations on how the change in classification has impacted citizens’ lives. This study examined the impact of revisions to the Infectious Disease Control Law in Japan on the social frailty and social life of older adults in the community.
Methods:
From mid-March to mid-April 2023, a self-administered survey targeting community-dwelling older adults aged 65 years and over was conducted by mail, before the revision of the Infectious Disease Control Law. From mid-February to mid-March 2024, after the revision of the law, a second survey was conducted among those who had responded to the first one. Ultimately, data from 240 cases were collected. The survey included social information such as mask-wearing when going out, status of long-term care insurance, presence of polypharmacy, sleep status, long outings, presence of COVID-19 infection, presence of post-COVID-19 syndrome (if infected), social frailty, and the Kihon Checklist, alongside basic demographic information.
Results:
After the revision of the Infectious Disease Control Law, there was an increase in the number of individuals receiving benefits from long-term care insurance and those identified as socially frail. However, no significant differences were observed in the other surveyed items.
Conclusion
The increase in socially frail individuals and those with long-term care insurance suggests that, despite the revision of the Infectious Disease Control Law, the connections within the local community that had once weakened due to the COVID-19 pandemic have not been fully restored.
7.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.
8.Translocation of the Isolated Left Vertebral Artery during Thoracic Endovascular Stent-Graft Repair
Takeshi ARAI ; Daichi TAKAGI ; Takuya WADA ; Itaru IGARASHI ; Yuya YAMAZAKI ; Wataru IGARASHI ; Takayuki KADOHAMA ; Hiroshi YAMAMOTO
Japanese Journal of Cardiovascular Surgery 2022;51(4):240-244
Spinal cord injury (SCI) is a main concern in patients who undergo thoracic endovascular therapy (TEVAR), because the blood flow of the vertebro-basilar artery may be reduced due to the left subclavian artery (LSA) occlusion. If the left vertebral artery originates directly from the aorta, which is called the isolated left vertebral artery (ILVA), a technical consideration for strategies regarding blood perfusion of the ILVA during TEVARs is required. We hereby aim to report three patients (No.1, No.2, and No.3) who underwent an ILVA translocation and TEVAR with Zone 2 landing for aortic dissection. The diameter of the ILVA was 4.2, 2.3, and 2.2 mm, respectively, and the right vertebral artery (RVA) was dominant in all cases. In Patient No.1 and No.2 (ILVA diameter: 4.2 and 2.3 mm, respectively), the ILVA was anastomosed directly to the left common carotid artery. In Patient No.2, the translocated ILVA was occluded resulting in SCI, but the SCI improved when blood pressure was augmented. In Patient No.3 (ILVA diameter: 2.2 mm), the saphenous vein graft was interposed between the ILVA and the bypass artery because the ILVA diameter was small, but postoperatively, the ILVA remained patent, and no paraplegia was observed. The occlusion of ILVA could cause SCI, even if the RVA is larger than the LVA. Reconstruction of the ILVA is a critical procedure to prevent postoperative SCIs in patients undergoing TEVARs.
9.Bispectral index-guided propofol sedation during endoscopic ultrasonography
Ayana OKAMOTO ; Ken KAMATA ; Takeshi MIYATA ; Tomoe YOSHIKAWA ; Rei ISHIKAWA ; Tomohiro YAMAZAKI ; Atsushi NAKAI ; Shunsuke OMOTO ; Kosuke MINAGA ; Kentaro YAMAO ; Mamoru TAKENAKA ; Yasutaka CHIBA ; Toshiharu SAKURAI ; Naoshi NISHIDA ; Masayuki KITANO ; Masatoshi KUDO
Clinical Endoscopy 2022;55(4):558-563
Background/Aims:
Bispectral index (BIS) monitors process and display electroencephalographic data are used to assess the depth of anesthesia. This study retrospectively evaluated the usefulness of BIS monitoring during endoscopic ultrasonography (EUS).
Methods:
This study included 725 consecutive patients who underwent EUS under sedation with propofol. BIS monitoring was used in 364 patients and was not used in 361. The following parameters were evaluated: (1) median dose of propofol; (2) respiratory and circulatory depression; (3) occurrence of body movements; (4) awakening score >8 at the time; and (5) awakening score 2 hours after leaving the endoscopy room.
Results:
The BIS group received a significantly lower median dose of propofol than the non-BIS group (159.2 mg vs. 167.5 mg; p=0.015) in all age groups. For patients aged ≥75 years, the reduction in heart rate was significantly lower in the BIS group than in the non-BIS group (1.2% vs. 9.1%; p=0.023). Moreover, the occurrence of body movements was markedly lower in the BIS group than in the non-BIS group (8.5% vs. 39.4%; p<0.001).
Conclusions
During EUS examination, BIS monitoring is useful for maintaining a constant depth of anesthesia, especially in patients 75 years of age or older.
10.Direct reduction and repair of spondylolysis with grade 1 slip using the smiley face rod: a case report
Shun OKUWAKI ; Masaki TATSUMURA ; Hisanori GAMADA ; Takeshi OGAWA ; Takeo MAMMOTO ; Atsushi HIRANO ; Masashi YAMAZAKI
Journal of Rural Medicine 2021;16(1):56-61
Objective: Lumbar spondylolysis, caused by stress fracture of the pars interarticularis may lead to a bony defect or spondylolisthesis. In adolescents, its surgical treatment employs the smiley face rod method for direct reduction of pseudoarthrotic spondylolysis and spondylolisthesis. Clinical outcomes of this treatment have been occasionally described; however, implant removal has not been discussed previously. We present a patient with lumbar spondylolysis with grade 1 slip at the 5th lumbar vertebra (L5) per the Meyerding classification.Patient: A 14-year-old boy presented with chronic severe lower back pain. Since conservative therapy did not resolve pain or enable resuming sports activities, the smiley face rod repair was performed 7 months after the initial treatment.Result: Anterior slippage of the L5 was surgically reduced. The patient wore a brace for 3 months postoperatively, and partial bone fusion was noted 6 months postoperatively. He resumed his sports activity 8 months postoperatively, and absolute bone fusion was confirmed 18 months postoperatively. Implant removal was performed 3 years postoperatively. Grade 1 slip was corrected with absolute bone fusion, and long-term follow-up revealed good results in terms of healing and rehabilitation.Conclusion: Smiley face rod method that allows for implant removal after bone fusion is suitable for adolescents.


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