1.Predictive Factors for Increased Bone Density Following Romosozumab Administration Based on Pre-Administration Blood Test Results
Akira KUWABARA ; Kazuhide INAGE ; Masaomi YAMASHITA ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masahiro INOUE ; Miyako SUZUKI-NARITA ; Takahisa HISHIYA ; Takahito ARAI ; Noriyasu TOSHI ; Kohei OKUYAMA ; Soichiro TOKESHI ; Susumu TASHIRO ; Shuhei OHYAMA ; Noritaka SUZUKI ; Seiji OHTORI
Yonsei Medical Journal 2025;66(4):226-232
Purpose:
Romosozumab reportedly increases bone density in patients with severe osteoporosis; however, data on its clinical effects are limited. We conducted a multicenter retrospective survey to study the bone density-increasing effects of romosozumab and blood test-based predictive factors in patients with severe osteoporosis, examining its effects in clinical practice.
Materials and Methods:
This was a multicenter retrospective observational study. The subjects were patients with severe osteoporosis who were treated with romosozumab at the participating facilities. The increase in bone density was assessed by comparing bone density changes (as a percentage) in the lumbar spine, femoral neck, and total femur before and 12 months after administration using dual-energy X-ray absorptiometry. The association between changes in bone density at each site and pre-treatment bone metabolism markers (Tracp 5b, P1NP), serum calcium levels, nutritional status [Conut score: albumin, total cholesterol (TCho), and total lymphocyte count], and kidney function (eGFR) was assessed.
Results:
In both naïve patients and those switching from bone resorption inhibitors, the bone density increased significantly. In naïve patients, eGFR were positively associated with bone density in the total femur. In cases of switching from bone resorption inhibitors, correlations were found between Tracp 5b and lumbar spine bone mineral density (BMD), as well as between Tracp 5b, Alb, T-Cho, and eGFR in the total femur BMD.
Conclusion
Romosozumab administration significantly increases bone density in osteoporosis, and assessing key predictive factors is necessary to ensure clinical effectiveness.
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.Emergent treatment using balloon-assisted ERCP versus EUS-guided drainage for acute cholangitis in patients with surgically altered anatomy
Takahiro SHISHIMOTO ; Masahiro ITONAGA ; Reiko ASHIDA ; Yasunobu YAMASHITA ; Yuki KAWAJI ; Takashi TAMURA ; Hiromu MORISHITA ; Akiya NAKAHATA ; Yuto SUGIHARA ; Tomokazu ISHIHARA ; Masayuki KITANO
International Journal of Gastrointestinal Intervention 2025;14(1):2-8
Background:
No studies have compared balloon-assisted endoscope-guided endoscopic retrograde cholangiopancreatography (BAE-ERCP) and endoscopic ultrasonography-guided biliary drainage (EUS-BD) for emergent treatment of acute cholangitis (AC) in patients with upper gastrointestinal surgically altered anatomy (SAA).
Methods:
This study retrospectively evaluated consecutive patients who underwent emergent BAE-ERCP or EUS-BD for AC with SAA between January 2020 and March 2024. Technical success, clinical success, procedure time, and adverse events (AEs) were compared between the two groups.
Results:
This study included 23 patients in the BAE-ERCP group and 14 patients in the EUS-BD group. Technical success and clinical success rates did not significantly differ between the two groups (88% vs. 100%, P = 0.51 and 95% vs. 93%, P = 0.66). Similarly, the rate of AEs was comparable between the two groups (4% vs. 14%, P = 0.54). The median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [interquartile range; IQR, 28.8–52.5] minutes vs. 70.0 [IQR, 60.0–90.0] minutes, P < 0.01). In cases with grade 2 or 3 cholangitis, the rates of technical success, clinical success, and AEs did not significantly differ between the two groups. However, the median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [IQR, 28.8–52.5] minutes vs. 70 [IQR, 56.3–90.0] minutes, P < 0.01).
Conclusion
While both BAE-ERCP and EUS-BD can be performed safely and effectively in patients with AC and SAA, the procedure time is significantly shorter with EUS-BD than with BAE-ERCP.
4.Novel technique for endoscopic ultrasound-guided gallbladder drainage to skip the needle tract dilation step: Efficacy of a 6-mm antimigration metal stent with a thin, tapered delivery catheter
Keiichi HATAMARU ; Masayuki KITANO ; Masahiro ITONAGA ; Yasunobu YAMASHITA ; Takashi TAMURA ; Yuki KAWAJI ; Junya NUTA
International Journal of Gastrointestinal Intervention 2025;14(1):9-14
Background:
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has been recognized as an effective treatment for patients at high risk for surgery. An antimigration metal stent with tapered thin delivery system has recently been developed. The aims of this study were to evaluate the feasibility, safety, and longterm outcomes of EUS-GBD using the new metal stent.
Methods:
Between April 2017 and March 2020, 21 patients with acute cholecystitis unsuitable for cholecystectomy underwent EUS-GBD using the metal stent. The stent was 6 mm in diameter and 6 cm in length, with a large flare at both ends for antimigration, and mounted in a 7.5 Fr delivery catheter, which requires no dilation devices. We retrospectively evaluated clinical and technical success, adverse events, and stent patency.
Results:
The technical and clinical success rates of EUS-GBD using the metal stent were 95.2% and 100%, respectively. For 75% of the patients, metal stents could be placed without dilatation of the needle tract. These patients had significantly shorter procedure time (23.6 ± 9.8 min) than patients requiring needle tract dilatation (38.4 ± 17.1 min; P = 0.036). The median follow-up periods were 336 days (interquartile range [IQR] 152–919 days) and 1,135 days (IQR 1,009–1,675 days) for all and alive patients, respectively. No adverse events or recurrence of cholecystitis due to stent occlusion that occurred in any patient at follow-up was observed.
Conclusion
In conclusion, EUS-GBD using the newly designed metal stent showed excellent safety and longterm outcomes, and may be suitable as an alternative treatment in patients who are unsuitable for cholecystectomy.
5.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.
6.Emergent treatment using balloon-assisted ERCP versus EUS-guided drainage for acute cholangitis in patients with surgically altered anatomy
Takahiro SHISHIMOTO ; Masahiro ITONAGA ; Reiko ASHIDA ; Yasunobu YAMASHITA ; Yuki KAWAJI ; Takashi TAMURA ; Hiromu MORISHITA ; Akiya NAKAHATA ; Yuto SUGIHARA ; Tomokazu ISHIHARA ; Masayuki KITANO
International Journal of Gastrointestinal Intervention 2025;14(1):2-8
Background:
No studies have compared balloon-assisted endoscope-guided endoscopic retrograde cholangiopancreatography (BAE-ERCP) and endoscopic ultrasonography-guided biliary drainage (EUS-BD) for emergent treatment of acute cholangitis (AC) in patients with upper gastrointestinal surgically altered anatomy (SAA).
Methods:
This study retrospectively evaluated consecutive patients who underwent emergent BAE-ERCP or EUS-BD for AC with SAA between January 2020 and March 2024. Technical success, clinical success, procedure time, and adverse events (AEs) were compared between the two groups.
Results:
This study included 23 patients in the BAE-ERCP group and 14 patients in the EUS-BD group. Technical success and clinical success rates did not significantly differ between the two groups (88% vs. 100%, P = 0.51 and 95% vs. 93%, P = 0.66). Similarly, the rate of AEs was comparable between the two groups (4% vs. 14%, P = 0.54). The median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [interquartile range; IQR, 28.8–52.5] minutes vs. 70.0 [IQR, 60.0–90.0] minutes, P < 0.01). In cases with grade 2 or 3 cholangitis, the rates of technical success, clinical success, and AEs did not significantly differ between the two groups. However, the median procedure time was significantly shorter in the EUS-BD group than in the BAE-ERCP group (32.5 [IQR, 28.8–52.5] minutes vs. 70 [IQR, 56.3–90.0] minutes, P < 0.01).
Conclusion
While both BAE-ERCP and EUS-BD can be performed safely and effectively in patients with AC and SAA, the procedure time is significantly shorter with EUS-BD than with BAE-ERCP.
7.Novel technique for endoscopic ultrasound-guided gallbladder drainage to skip the needle tract dilation step: Efficacy of a 6-mm antimigration metal stent with a thin, tapered delivery catheter
Keiichi HATAMARU ; Masayuki KITANO ; Masahiro ITONAGA ; Yasunobu YAMASHITA ; Takashi TAMURA ; Yuki KAWAJI ; Junya NUTA
International Journal of Gastrointestinal Intervention 2025;14(1):9-14
Background:
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has been recognized as an effective treatment for patients at high risk for surgery. An antimigration metal stent with tapered thin delivery system has recently been developed. The aims of this study were to evaluate the feasibility, safety, and longterm outcomes of EUS-GBD using the new metal stent.
Methods:
Between April 2017 and March 2020, 21 patients with acute cholecystitis unsuitable for cholecystectomy underwent EUS-GBD using the metal stent. The stent was 6 mm in diameter and 6 cm in length, with a large flare at both ends for antimigration, and mounted in a 7.5 Fr delivery catheter, which requires no dilation devices. We retrospectively evaluated clinical and technical success, adverse events, and stent patency.
Results:
The technical and clinical success rates of EUS-GBD using the metal stent were 95.2% and 100%, respectively. For 75% of the patients, metal stents could be placed without dilatation of the needle tract. These patients had significantly shorter procedure time (23.6 ± 9.8 min) than patients requiring needle tract dilatation (38.4 ± 17.1 min; P = 0.036). The median follow-up periods were 336 days (interquartile range [IQR] 152–919 days) and 1,135 days (IQR 1,009–1,675 days) for all and alive patients, respectively. No adverse events or recurrence of cholecystitis due to stent occlusion that occurred in any patient at follow-up was observed.
Conclusion
In conclusion, EUS-GBD using the newly designed metal stent showed excellent safety and longterm outcomes, and may be suitable as an alternative treatment in patients who are unsuitable for cholecystectomy.
8.Predictive Factors for Increased Bone Density Following Romosozumab Administration Based on Pre-Administration Blood Test Results
Akira KUWABARA ; Kazuhide INAGE ; Masaomi YAMASHITA ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masahiro INOUE ; Miyako SUZUKI-NARITA ; Takahisa HISHIYA ; Takahito ARAI ; Noriyasu TOSHI ; Kohei OKUYAMA ; Soichiro TOKESHI ; Susumu TASHIRO ; Shuhei OHYAMA ; Noritaka SUZUKI ; Seiji OHTORI
Yonsei Medical Journal 2025;66(4):226-232
Purpose:
Romosozumab reportedly increases bone density in patients with severe osteoporosis; however, data on its clinical effects are limited. We conducted a multicenter retrospective survey to study the bone density-increasing effects of romosozumab and blood test-based predictive factors in patients with severe osteoporosis, examining its effects in clinical practice.
Materials and Methods:
This was a multicenter retrospective observational study. The subjects were patients with severe osteoporosis who were treated with romosozumab at the participating facilities. The increase in bone density was assessed by comparing bone density changes (as a percentage) in the lumbar spine, femoral neck, and total femur before and 12 months after administration using dual-energy X-ray absorptiometry. The association between changes in bone density at each site and pre-treatment bone metabolism markers (Tracp 5b, P1NP), serum calcium levels, nutritional status [Conut score: albumin, total cholesterol (TCho), and total lymphocyte count], and kidney function (eGFR) was assessed.
Results:
In both naïve patients and those switching from bone resorption inhibitors, the bone density increased significantly. In naïve patients, eGFR were positively associated with bone density in the total femur. In cases of switching from bone resorption inhibitors, correlations were found between Tracp 5b and lumbar spine bone mineral density (BMD), as well as between Tracp 5b, Alb, T-Cho, and eGFR in the total femur BMD.
Conclusion
Romosozumab administration significantly increases bone density in osteoporosis, and assessing key predictive factors is necessary to ensure clinical effectiveness.
9.Bone marrow donors: experience among adolescents and young adults
Kotomi SATO ; Masahiro HARAGUCHI
Journal of Rural Medicine 2025;20(4):302-310
Objective: Recent treatment advancements have improved the survival rates of patients with hematological malignancies, making hematopoietic stem cell transplantation (HSCT) a key curative option. However, despite ongoing awareness efforts, the number of bone marrow donor registrations has not significantly increased over time, possibly because of the impact of recent infectious disease outbreaks. This may affect patients requiring allogeneic HSCT. This study explored the experiences of adolescent and young adult (AYA) bone marrow donors.Patient and Methods: Using a qualitative descriptive research design, we conducted semi-structured interviews with six AYA individuals who had experience as bone marrow donors. The study was approved by the institutional ethics committee (022-03), and no conflicts of interest were disclosed.Results: Seven categories and 23 subcategories were identified in this analysis. Participants reported a strong sense of duty as donors, but faced challenges such as family opposition, lack of understanding from employers, and concerns about the impact on work and family life. Despite these difficulties, donors often experienced personal growth and fulfillment through donation.Conclusion: Nurses should recognize AYA bone marrow donors as a population that requires support, and consider strategies to increase the understanding and registration among this crucial demographic group.
10.Impact of Autopsy Imaging (Ai) on Bereaved Families of Patients with Terminal Cancer
Masahiro KAWAHIRA ; Emika KUROKI ; Mayumi NOZAKI ; Jurio SHIMADA ; Satoshi MIYAKE
Palliative Care Research 2025;20(4):203-208
This study investigated the psychological impact of autopsy imaging (Ai) on bereaved families of patients with terminal cancer. These patients, one with pancreatic cancer of the body and tail and the other with intrahepatic cholangiocarcinoma, underwent Ai, and a mixed-methods survey was conducted with 7 bereaved family members using a self-administered questionnaire. Although the awareness of Ai was low (14.3%), all participants reported that Ai helped them understand the cause of death. Moreover, 71.4% felt that Ai was necessary. Qualitative analysis of free-text responses suggested that Ai contributed to a clearer understanding and acceptance of the cause of death and provided psychological reassurance. On the other hand, it became evident that the implementation of Ai could evoke emotional conflict and complex feelings in bereaved families. Therefore, confirming the patient’s wishes and providing psychological support to both the patient and their family are essential when conducting Ai. In the future, it will be essential for medical professionals to carefully explain the purpose and significance of Ai during advance care planning discussions, and to consider its implementation while respecting the wishes of both the patient and their family.


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