1.Insufficient evaluation of S2 alar iliac screw malposition with the intraoperative inlet view: utility of the obturator inlet and iliac oblique views
Shun OKUWAKI ; Toru FUNAYAMA ; Yohei YANAGISAWA ; Takahiro SUNAMI ; Takane NAKAGAWA ; Yosuke OGATA ; Kotaro SAKASHITA ; Hisanori GAMADA ; Kousei MIURA ; Hiroshi NOGUCHI ; Hiroshi TAKAHASHI ; Masao KODA
Asian Spine Journal 2026;20(2):302-312
Methods:
We analyzed data from 101 patients who underwent spinopelvic surgery involving 202 S2AI screws. Postoperative computed tomography (CT) images were reviewed to identify screw deviations. The reconstructed fluoroscopic views from CT, including the inlet, OI, and IO views, were assessed for their effectiveness in detecting deviations. An experimental study using pelvic bone models simulated scenarios where deviations were undetectable in the inlet view but visible in the OI view.
Results:
Screw deviations were identified in 12 cases (11.9%) and 13 screws (6.4%), including six screws (3.0%) with anterior deviations and seven screws (3.5%) with posterior deviations. The accurate inlet view detected anterior deviations in three of the five cases analyzed with reconstructed images. However, two cases of anterior deviation were missed due to an insufficient inlet view caused by a 30° caudal tilting angle. In contrast, the OI view successfully identified all cases of both anterior and posterior deviations. In particular, deviations above the arcuate line of the pelvic brim were not detectable in the inlet view.
Conclusions
The inlet view alone is inadequate for detecting anterior deviations, especially those located above the arcuate line of the pelvis. The OI and IO views demonstrated greater effectiveness in identifying deviations, thereby enhancing the accuracy and safety of S2AI screw placement.
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.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.Comprehension Tests and Investigation of Graphical Symbols for Effectively Communicating Precaution Information in Package Inserts for Over-The-Counter Drugs
Anna TAKAHASHI ; Jun YAMASHITA ; Noboru NAKAMICHI ; Naoko NARAHARA ; Hirofumi INOUE ; Hiroshi TAKANE ; Tohru AOMORI ; Mayumi MOCHIZUKI
Japanese Journal of Drug Informatics 2024;26(3):136-143
Objective: Self-medication is promoted to extend healthy life expectancy. Accordingly, it is important for general consumers to properly use over-the-counter drugs. We investigated whether graphical symbols to visually aid the understanding of drug information (i.e., precautions and instructions to consult with a medical professional) provided in over-the-counter drug package inserts are easily understood in light of the International Organization for Standardization (ISO) criterion of 66% comprehension. Methods: First, two questionnaire surveys were conducted with pharmacy students to calculate their comprehension level of the illustrations. The first round was for modifying illustrations that did not meet the ISO standard, and the second round was for seeing if comprehension had improved. Then, a questionnaire survey targeting general consumers was conducted to see if these illustrations functioned as graphical symbols. Results: When the referent of “Do not take this medicine if your experience falls under the following conditions” was placed in the upper left corner of the symbol, some students answered that this meant, “If you do not take this medicine, you will be under the following conditions,” but when it was placed in the lower right corner, many students accurately understood the intended information. In the student surveys, one illustration each for “cannot be taken/under treatment/heart,” “cannot be taken/under treatment/stomach,” “cannot be taken/under treatment/liver,” and “cannot be taken/under treatment/kidney” all exceeded 66%. Since none of the illustrations exceeded the 66% comprehension in the survey of general consumers, it was found to be difficult for general consumers to understand drug information from the present illustrations. However, there were several illustrations that improved in comprehension compared to the previous study, which makes the continuation of this study significant. Conclusion: Although there were no illustrations exceeded 66% comprehension of general consumers, the study shows that continued improvement may result in establishing pictograms for general consumers.
7.Washout-parametric imaging with Sonazoid for enhanced differentiation of focal liver lesions
Tatsuya KAKEGAWA ; Katsutoshi SUGIMOTO ; Naohisa KAMIYAMA ; Hiroshi HASHIMOTO ; Hiroshi TAKAHASHI ; Takuya WADA ; Yu YOSHIMASU ; Hirohito TAKEUCHI ; Ryohei NAKAYAMA ; Kentaro SAKAMAKI ; Takao ITOI
Ultrasonography 2024;43(6):457-468
Purpose:
The study aimed to compare the diagnostic performance of washout-parametric imaging (WOPI) with that of conventional contrast-enhanced ultrasound (cCEUS) in differentiating focal liver lesions (FLLs).
Methods:
A total of 181 FLLs were imaged with contrast-enhanced ultrasound using Sonazoid, and the recordings were captured for 10 minutes in a prospective setting. WOPI was constructed from three images, depicting the arterial phase (peak enhancement), the early portal venous phase (1-minute post-injection), and the vasculo-Kupffer phase (5 or 10 minutes post-injection). The intensity variations in these images were color-coded and superimposed to produce a single image representing the washout timing across the lesions. From the 181 FLLs, 30 hepatocellular carcinomas (HCCs), 30 non-HCC malignancies, and 30 benign lesions were randomly selected for an observer study. Both techniques (cCEUS and WOPI) were evaluated by four off-site readers. They classified each lesion as benign or malignant using a continuous rating scale, with the endpoints representing "definitely benign" and "definitely malignant." The diagnostic performance of cCEUS and WOPI was compared using the area under the receiver operating characteristic curve (AUC) with the DeLong test. Interobserver agreement was assessed using the intraclass correlation coefficient (ICC).
Results:
The difference in average AUC values between WOPI and cCEUS was 0.0062 (95% confidence interval, -0.0161 to 0.0285), indicating no significant difference between techniques. The interobserver agreement was higher for WOPI (ICC, 0.77) than cCEUS (ICC, 0.67).
Conclusion
The diagnostic performance of WOPI is comparable to that of cCEUS in differentiating FLLs, with superior interobserver agreement.
8.Washout-parametric imaging with Sonazoid for enhanced differentiation of focal liver lesions
Tatsuya KAKEGAWA ; Katsutoshi SUGIMOTO ; Naohisa KAMIYAMA ; Hiroshi HASHIMOTO ; Hiroshi TAKAHASHI ; Takuya WADA ; Yu YOSHIMASU ; Hirohito TAKEUCHI ; Ryohei NAKAYAMA ; Kentaro SAKAMAKI ; Takao ITOI
Ultrasonography 2024;43(6):457-468
Purpose:
The study aimed to compare the diagnostic performance of washout-parametric imaging (WOPI) with that of conventional contrast-enhanced ultrasound (cCEUS) in differentiating focal liver lesions (FLLs).
Methods:
A total of 181 FLLs were imaged with contrast-enhanced ultrasound using Sonazoid, and the recordings were captured for 10 minutes in a prospective setting. WOPI was constructed from three images, depicting the arterial phase (peak enhancement), the early portal venous phase (1-minute post-injection), and the vasculo-Kupffer phase (5 or 10 minutes post-injection). The intensity variations in these images were color-coded and superimposed to produce a single image representing the washout timing across the lesions. From the 181 FLLs, 30 hepatocellular carcinomas (HCCs), 30 non-HCC malignancies, and 30 benign lesions were randomly selected for an observer study. Both techniques (cCEUS and WOPI) were evaluated by four off-site readers. They classified each lesion as benign or malignant using a continuous rating scale, with the endpoints representing "definitely benign" and "definitely malignant." The diagnostic performance of cCEUS and WOPI was compared using the area under the receiver operating characteristic curve (AUC) with the DeLong test. Interobserver agreement was assessed using the intraclass correlation coefficient (ICC).
Results:
The difference in average AUC values between WOPI and cCEUS was 0.0062 (95% confidence interval, -0.0161 to 0.0285), indicating no significant difference between techniques. The interobserver agreement was higher for WOPI (ICC, 0.77) than cCEUS (ICC, 0.67).
Conclusion
The diagnostic performance of WOPI is comparable to that of cCEUS in differentiating FLLs, with superior interobserver agreement.
9.Washout-parametric imaging with Sonazoid for enhanced differentiation of focal liver lesions
Tatsuya KAKEGAWA ; Katsutoshi SUGIMOTO ; Naohisa KAMIYAMA ; Hiroshi HASHIMOTO ; Hiroshi TAKAHASHI ; Takuya WADA ; Yu YOSHIMASU ; Hirohito TAKEUCHI ; Ryohei NAKAYAMA ; Kentaro SAKAMAKI ; Takao ITOI
Ultrasonography 2024;43(6):457-468
Purpose:
The study aimed to compare the diagnostic performance of washout-parametric imaging (WOPI) with that of conventional contrast-enhanced ultrasound (cCEUS) in differentiating focal liver lesions (FLLs).
Methods:
A total of 181 FLLs were imaged with contrast-enhanced ultrasound using Sonazoid, and the recordings were captured for 10 minutes in a prospective setting. WOPI was constructed from three images, depicting the arterial phase (peak enhancement), the early portal venous phase (1-minute post-injection), and the vasculo-Kupffer phase (5 or 10 minutes post-injection). The intensity variations in these images were color-coded and superimposed to produce a single image representing the washout timing across the lesions. From the 181 FLLs, 30 hepatocellular carcinomas (HCCs), 30 non-HCC malignancies, and 30 benign lesions were randomly selected for an observer study. Both techniques (cCEUS and WOPI) were evaluated by four off-site readers. They classified each lesion as benign or malignant using a continuous rating scale, with the endpoints representing "definitely benign" and "definitely malignant." The diagnostic performance of cCEUS and WOPI was compared using the area under the receiver operating characteristic curve (AUC) with the DeLong test. Interobserver agreement was assessed using the intraclass correlation coefficient (ICC).
Results:
The difference in average AUC values between WOPI and cCEUS was 0.0062 (95% confidence interval, -0.0161 to 0.0285), indicating no significant difference between techniques. The interobserver agreement was higher for WOPI (ICC, 0.77) than cCEUS (ICC, 0.67).
Conclusion
The diagnostic performance of WOPI is comparable to that of cCEUS in differentiating FLLs, with superior interobserver agreement.
10.Exploring factors affecting activities of daily living in patients with osteoporotic vertebral fractures managed conservatively: a post-hoc analysis of a prospective cohort study
Toru FUNAYAMA ; Masaki TATSUMURA ; Kengo FUJII ; Yosuke SHIBAO ; Shun OKUWAKI ; Kotaro SAKASHITA ; Takahiro SUNAMI ; Kento INOMATA ; Hisanori GAMADA ; Kousei MIURA ; Hiroshi NOGUCHI ; Hiroshi TAKAHASHI ; Masao KODA ; Masashi YAMAZAKI
Asian Spine Journal 2024;18(4):570-578
Methods:
A total of 224 consecutive patients with OVFs aged ≥65 years who received treatment within 2 weeks after the occurrence of injury were enrolled. The patients were followed up for 6 months thereafter. The criteria for evaluating the degree of independence were applied to evaluate ADLs. Multivariable analysis with a logistic regression model was performed to evaluate the risk factors for ADL decline.
Results:
In total, 49/224 patients (21.9%) showed a decline in ADLs. Of these, 23/116 patients (19.8%) in the rest group and 26/108 patients (24.1%) in the no-rest group experienced a decline in ADLs. In the logistic regression analyses, a diffuse low signal on T2- weighted magnetic resonance imaging (MRI) (odds ratio, 5.78; 95% confidence interval, 2.09–16.0; p=0.0007) and vertebral instability (odds ratio, 3.89; 95% confidence interval, 1.32–11.4; p=0.0135) were identified as independent factors in the rest and no-rest groups, respectively.
Conclusions
In patients with acute OVFs, a diffuse low signal on T2-weighted MRI and severe vertebral instability were independently associated with ADL decline in patients treated with and without initial bed rest, respectively.


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