1.Endoscopic ultrasound-guided drainage of postoperative pancreatic fluid collections
Shigeru NISHIYAMA ; Takeshi HISA ; Aki EGO ; Shogo SAKATA ; Yui ITO ; Akiharu KUDO ; Takahiro YAMADA ; Shozo OSERA ; Hideki FUKUSHIMA ; Shunta ISHIZAKI ; Ryoga HAMURA ; Masashi TSUNEMATSU ; Kyohei ABE ; Yoshihiro SHIRAI ; Shinji ONDA
International Journal of Gastrointestinal Intervention 2025;14(1):15-19
Background:
Endoscopic ultrasound-guided drainage (EUSD) is an effective treatment for postoperative pancreatic fluid collections (POPFCs); however, standards regarding stents used for EUSD have not been established. This study analyzed the outcomes of EUSD of POPFCs at our hospital and examined the safety and effectiveness of plastic stents/tubes.
Methods:
This retrospective, single-center study focused on EUSD of POPFCs performed at our hospital. We examined the rates of technical success, clinical success, adverse events, and recurrence.
Results:
Twenty-seven patients were included in this study. The initial drainage methods comprised one nasocystic plastic tube (NPT) and one double-pigtail plastic stent (DPS) for 19 (70.4%) patients, two DPS for four (14.8%) patients, one NPT for three (11.1%) patients, and one lumen-apposing metal stent for one (3.7%) patient. The technical success and clinical success rates were both 100%. Fourteen of the 19 patients with one NPT and one DPS improved, but five patients required additional interventions and improved with fistula site dilation. Although recurrence occurred in one patient, improvement was achieved with second EUSD. Early adverse events comprised one case of bleeding for which hemostasis was achieved by performing coil embolization. Late adverse events comprised three cases of DPS migration; however, no additional intervention was required.
Conclusion
The use of plastic tubes/stents is safe and effective for EUSD of POPFCs.
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.Endoscopic ultrasound-guided drainage of postoperative pancreatic fluid collections
Shigeru NISHIYAMA ; Takeshi HISA ; Aki EGO ; Shogo SAKATA ; Yui ITO ; Akiharu KUDO ; Takahiro YAMADA ; Shozo OSERA ; Hideki FUKUSHIMA ; Shunta ISHIZAKI ; Ryoga HAMURA ; Masashi TSUNEMATSU ; Kyohei ABE ; Yoshihiro SHIRAI ; Shinji ONDA
International Journal of Gastrointestinal Intervention 2025;14(1):15-19
Background:
Endoscopic ultrasound-guided drainage (EUSD) is an effective treatment for postoperative pancreatic fluid collections (POPFCs); however, standards regarding stents used for EUSD have not been established. This study analyzed the outcomes of EUSD of POPFCs at our hospital and examined the safety and effectiveness of plastic stents/tubes.
Methods:
This retrospective, single-center study focused on EUSD of POPFCs performed at our hospital. We examined the rates of technical success, clinical success, adverse events, and recurrence.
Results:
Twenty-seven patients were included in this study. The initial drainage methods comprised one nasocystic plastic tube (NPT) and one double-pigtail plastic stent (DPS) for 19 (70.4%) patients, two DPS for four (14.8%) patients, one NPT for three (11.1%) patients, and one lumen-apposing metal stent for one (3.7%) patient. The technical success and clinical success rates were both 100%. Fourteen of the 19 patients with one NPT and one DPS improved, but five patients required additional interventions and improved with fistula site dilation. Although recurrence occurred in one patient, improvement was achieved with second EUSD. Early adverse events comprised one case of bleeding for which hemostasis was achieved by performing coil embolization. Late adverse events comprised three cases of DPS migration; however, no additional intervention was required.
Conclusion
The use of plastic tubes/stents is safe and effective for EUSD of POPFCs.
6.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.
7.Endoscopic ultrasound-guided drainage of postoperative pancreatic fluid collections
Shigeru NISHIYAMA ; Takeshi HISA ; Aki EGO ; Shogo SAKATA ; Yui ITO ; Akiharu KUDO ; Takahiro YAMADA ; Shozo OSERA ; Hideki FUKUSHIMA ; Shunta ISHIZAKI ; Ryoga HAMURA ; Masashi TSUNEMATSU ; Kyohei ABE ; Yoshihiro SHIRAI ; Shinji ONDA
International Journal of Gastrointestinal Intervention 2025;14(1):15-19
Background:
Endoscopic ultrasound-guided drainage (EUSD) is an effective treatment for postoperative pancreatic fluid collections (POPFCs); however, standards regarding stents used for EUSD have not been established. This study analyzed the outcomes of EUSD of POPFCs at our hospital and examined the safety and effectiveness of plastic stents/tubes.
Methods:
This retrospective, single-center study focused on EUSD of POPFCs performed at our hospital. We examined the rates of technical success, clinical success, adverse events, and recurrence.
Results:
Twenty-seven patients were included in this study. The initial drainage methods comprised one nasocystic plastic tube (NPT) and one double-pigtail plastic stent (DPS) for 19 (70.4%) patients, two DPS for four (14.8%) patients, one NPT for three (11.1%) patients, and one lumen-apposing metal stent for one (3.7%) patient. The technical success and clinical success rates were both 100%. Fourteen of the 19 patients with one NPT and one DPS improved, but five patients required additional interventions and improved with fistula site dilation. Although recurrence occurred in one patient, improvement was achieved with second EUSD. Early adverse events comprised one case of bleeding for which hemostasis was achieved by performing coil embolization. Late adverse events comprised three cases of DPS migration; however, no additional intervention was required.
Conclusion
The use of plastic tubes/stents is safe and effective for EUSD of POPFCs.
8.Prognosis of biopsy-confirmed metabolic dysfunction- associated steatotic liver disease: A sub-analysis of the CLIONE study
Michihiro IWAKI ; Hideki FUJII ; Hideki HAYASHI ; Hidenori TOYODA ; Satoshi OEDA ; Hideyuki HYOGO ; Miwa KAWANAKA ; Asahiro MORISHITA ; Kensuke MUNEKAGE ; Kazuhito KAWATA ; Tsubasa TSUTSUMI ; Koji SAWADA ; Tatsuji MAESHIRO ; Hiroshi TOBITA ; Yuichi YOSHIDA ; Masafumi NAITO ; Asuka ARAKI ; Shingo ARAKAKI ; Takumi KAWAGUCHI ; Hidenao NORITAKE ; Masafumi ONO ; Tsutomu MASAKI ; Satoshi YASUDA ; Eiichi TOMITA ; Masato YONEDA ; Akihiro TOKUSHIGE ; Yoshihiro KAMADA ; Hirokazu TAKAHASHI ; Shinichiro UEDA ; Shinichi AISHIMA ; Yoshio SUMIDA ; Atsushi NAKAJIMA ; Takeshi OKANOUE ;
Clinical and Molecular Hepatology 2024;30(2):225-234
Background/Aims:
Metabolic dysfunction-associated steatotic liver disease (MASLD) was recently proposed as an alternative disease concept to nonalcoholic fatty liver disease (NAFLD). We aimed to investigate the prognosis of patients with biopsy-confirmed MASLD using data from a multicenter study.
Methods:
This was a sub-analysis of the Clinical Outcome Nonalcoholic Fatty Liver Disease (CLIONE) study that included 1,398 patients with NAFLD. Liver biopsy specimens were pathologically diagnosed and histologically scored using the NASH Clinical Research Network system, the FLIP algorithm, and the SAF score. Patients who met at least one cardiometabolic criterion were diagnosed with MASLD.
Results:
Approximately 99% of cases (n=1,381) were classified as MASLD. Patients with no cardiometabolic risk (n=17) had a significantly lower BMI than patients with MASLD (20.9 kg/m2 vs. 28.0 kg/m2, P<0.001), in addition to significantly lower levels of inflammation, ballooning, NAFLD activity score, and fibrosis stage based on liver histology. These 17 patients had a median follow-up of 5.9 years, equivalent to 115 person-years, with no deaths, liver-related events, cardiovascular events, or extrahepatic cancers. The results showed that the prognosis for pure MASLD was similar to that for the original CLIONE cohort, with 47 deaths and one patient who underwent orthotopic liver transplantation. The leading cause of death was extrahepatic cancer (n=10), while the leading causes of liver-related death were liver failure (n=9), hepatocellular carcinoma (n=8), and cholangiocarcinoma (n=4).
Conclusions
Approximately 99% of NAFLD cases were considered MASLD based on the 2023 liver disease nomenclature. The NAFLD-only group, which is not encompassed by MASLD, had a relatively mild histopathologic severity and a favorable prognosis. Consequently, the prognosis of MASLD is similar to that previously reported for NAFLD.
9.Improvements in Intractable Lumbar and LowerExtremity Symptoms after Systemic Administration of Tocilizumab, an Anti-interleukin-6 Receptor Antibody
Takeshi SAINOH ; Takeshi SAINOH ; Sumihisa ORITA ; Sumihisa ORITA ; Masayuki MIYAGI ; Masayuki MIYAGI ; Miyako SUZUKI-NARITA ; Miyako SUZUKI-NARITA ; Yoshihiro SAKUMA ; Yoshihiro SAKUMA ; Yasuhiro OIKAWA ; Yasuhiro OIKAWA ; Go KUBOTA ; Go KUBOTA ; Jun SATO ; Jun SATO ; Yasuhiro SHIGA ; Yasuhiro SHIGA ; Kazuki FUJIMOTO ; Kazuki FUJIMOTO ; Yawara EGUCHI ; Yawara EGUCHI ; Masao KODA ; Masao KODA ; Yasuchika AOKI ; Yasuchika AOKI ; Tsutomu AKAZAWA ; Tsutomu AKAZAWA ; Takeo FURUYA ; Takeo FURUYA ; Junichi NAKAMURA ; Junichi NAKAMURA ; Hiroshi TAKAHASHI ; Hiroshi TAKAHASHI ; Satoshi MAKI ; Satoshi MAKI ; Masahiro INOUE ; Masahiro INOUE ; Hideyuki KINOSHITA ; Hideyuki KINOSHITA ; Masaki NORIMOTO ; Masaki NORIMOTO ; Takashi SATO ; Takashi SATO ; Masashi SATO ; Masashi SATO ; Masahiro SUZUKI ; Masahiro SUZUKI ; Keigo ENOMOTO ; Keigo ENOMOTO ; Hiromitsu TAKAOKA ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Norichika MIZUKI ; Takashi HOZUMI ; Takashi HOZUMI ; Ryuto TSUCHIYA ; Ryuto TSUCHIYA ; Geundong KIM ; Geundong KIM ; Takuma OTAGIRI ; Takuma OTAGIRI ; Tomohito MUKAIHATA ; Tomohito MUKAIHATA ; Takahisa HISHIYA ; Takahisa HISHIYA ; Seiji OHTORI ; Seiji OHTORI ; Kazuhide INAGE ; Kazuhide INAGE
Asian Spine Journal 2022;16(1):99-106
Methods:
This prospective, single-arm study included 11 patients (eight men; mean age, 62.7 years) with ≥3-months’ chronic pain history due to lumbar disease. Subcutaneous TCZ injections were administered twice, at a 2-week interval. We evaluated low back pain, leg pain, and leg numbness using numeric rating scales and the Oswestry Disability Index (ODI; baseline and 6 months postinjection); serum IL-6 and tumor necrosis factor-α levels (baseline and 1 month postinjection); and clinical adverse events.
Results:
Intractable symptoms reduced after TCZ administration. Low back pain improved for 6 months. Improvements in leg pain and numbness peaked at 4 and 1 month, respectively. Improvements in ODI were significant at 1 month and peaked at 4 months. Serum IL-6 was increased at 1 month. IL-6 responders (i.e., patients with IL-6 increases >10 pg/mL) showed particularly significant improvements in leg pain at 2 weeks, 1 month, and 2 months compared with nonresponders. We observed no apparent adverse events.
Conclusions
Systemic TCZ administration improved symptoms effectively for 6 months, with peak improvements at 1–4 months and no adverse events. Changing serum IL-6 levels correlated with leg pain improvements; further studies are warranted to elucidate the mechanistic connections between lumbar disorders and inflammatory cytokines.
10.Effects of Co-management of the Neurosurgery Department by General Physicians
Hiroyuki YAMAMOTO ; Kentaro KAMEDA ; Mamoru KOMATSU ; Takeshi YOSHIHIRO ; Shouhei NOSHIRO ; Masafumi OHTAKI
An Official Journal of the Japan Primary Care Association 2022;45(3):74-81
Introduction: This study evaluated the effectiveness of co-management of the neurosurgery department by general physicians.Methods: A retrospective observational study was conducted in a tertiary hospital. Length of stay, in-hospital mortality, number of transfers to the intensive care unit (ICU) due to emergency medical problems, prescription sharing ratio with neurosurgeon, and impression reported by nurses were evaluated by comparing one year before and after the co-management of the neurosurgery department was initiated.Results: Length of stay (Median 14 days, 14 days), mortality rate (7.58%, 5.75%) and transfer rate for ICU (3.23%, 1.94%) were not significantly different between one year before and one year after, respectively. Subgroup analysis of patients over 70 years of age hospitalized for cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage showed that the number of patients transferred to the ICU due to medical problems associated with internal medicine significantly decreased (P = 0.04). A general physician was responsible for half of the prescriptions. The nurse's report was highly positive.Conclusion: Co-management of the neurosurgery department by general physicians did not have a significant effect on reducing length of stay or mortality rate; however, we found a decrease in the number of patients transferred to the ICU due to medical problems among elderly stroke patients.


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