1.Prevention of symptomatic pulmonary embolism for gynecologic malignancies with preoperative asymptomatic venous thromboembolism: GOTIC-VTE trial
Yoshifumi TAKAHASHI ; Hiroyuki FUJIWARA ; Kouji YAMAMOTO ; Masashi TAKANO ; Morikazu MIYAMOTO ; Kosei HASEGAWA ; Maiko MIWA ; Toyomi SATOH ; Hiroya ITAGAKI ; Takashi HIRAKAWA ; Mayuyo MORI-UCHINO ; Tomonori NAGAI ; Yoshinobu HAMADA ; Soichi YAMASHITA ; Hiroko YANO ; Tomoyasu KATO ; Keiichi FUJIWARA ; Mitsuaki SUZUKI ; On behalf of the GOTIC-VTE Trial Investigators
Journal of Gynecologic Oncology 2024;35(4):e37-
Objective:
In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression.
Methods:
Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events.
Results:
Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase).
Conclusion
The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124
2.Prevention of symptomatic pulmonary embolism for gynecologic malignancies with preoperative asymptomatic venous thromboembolism: GOTIC-VTE trial
Yoshifumi TAKAHASHI ; Hiroyuki FUJIWARA ; Kouji YAMAMOTO ; Masashi TAKANO ; Morikazu MIYAMOTO ; Kosei HASEGAWA ; Maiko MIWA ; Toyomi SATOH ; Hiroya ITAGAKI ; Takashi HIRAKAWA ; Mayuyo MORI-UCHINO ; Tomonori NAGAI ; Yoshinobu HAMADA ; Soichi YAMASHITA ; Hiroko YANO ; Tomoyasu KATO ; Keiichi FUJIWARA ; Mitsuaki SUZUKI ; On behalf of the GOTIC-VTE Trial Investigators
Journal of Gynecologic Oncology 2024;35(4):e37-
Objective:
In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression.
Methods:
Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events.
Results:
Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase).
Conclusion
The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124
3.Prevention of symptomatic pulmonary embolism for gynecologic malignancies with preoperative asymptomatic venous thromboembolism: GOTIC-VTE trial
Yoshifumi TAKAHASHI ; Hiroyuki FUJIWARA ; Kouji YAMAMOTO ; Masashi TAKANO ; Morikazu MIYAMOTO ; Kosei HASEGAWA ; Maiko MIWA ; Toyomi SATOH ; Hiroya ITAGAKI ; Takashi HIRAKAWA ; Mayuyo MORI-UCHINO ; Tomonori NAGAI ; Yoshinobu HAMADA ; Soichi YAMASHITA ; Hiroko YANO ; Tomoyasu KATO ; Keiichi FUJIWARA ; Mitsuaki SUZUKI ; On behalf of the GOTIC-VTE Trial Investigators
Journal of Gynecologic Oncology 2024;35(4):e37-
Objective:
In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression.
Methods:
Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events.
Results:
Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase).
Conclusion
The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124
4.Mucosal and Submucosal Thickening of Esophageal Wall Is a Promising Factor in the Development of Symptoms in Eosinophilic Esophagitis
Yugo SUZUKI ; Yorinari OCHIAI ; Atsuko HOSOI ; Takayuki OKAMURA ; Junnosuke HAYASAKA ; Yutaka MITSUNAGA ; Masami TANAKA ; Hiroyuki ODAGIRI ; Kosuke NOMURA ; Satoshi YAMASHITA ; Akira MATSUI ; Daisuke KIKUCHI ; Kenichi OHASHI ; Shu HOTEYA
Gut and Liver 2024;18(1):50-59
Background/Aims:
Asymptomatic esophageal eosinophilia (aEE) is considered to be a potential precursor of eosinophilic esophagitis (EoE). However, there are few clinical parameters that can be used to evaluate the disease. Therefore, we aimed to clarify the factors involved in the symptoms of EoE by examining the clinicopathological differences between aEE and EoE.
Methods:
We reviewed 41 patients with esophageal eosinophilia who underwent endoscopic ultrasonography and high-resolution manometry. They were divided into the aEE group (n=16) and the EoE group (n=25) using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease score. The patients’ clinicopathological findings were collected and examined.
Results:
The median Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease score was 3.0 in the aEE group and 10.0 in the EoE group. There was no significant difference in patient characteristics, endoscopic findings and pathological findings. The cutoff value for wall thickening was 3.13 mm for the total esophageal wall thickness and 2.30 mm for the thickness from the surface to the muscular layer (total esophageal wall thickness: 84.0% sensitivity, 75.0% specificity; thickness from the surface to the muscular layer: 84.0% sensitivity, 68.7% specificity).The high-resolution manometry study was abnormal in seven patients (43.8%) in the aEE group and in 12 (48.0%) in the EoE group. The contractile front velocity was slower in the EoE group (p=0.026).
Conclusions
The esophageal wall thickening in the lower portion of the esophagus is an important clinical factors related to the symptoms in patients with EoE.
5.Magnetic Resonance Spectroscopic Analysis of Multifidus Muscle Lipid Contents and Association with Nociceptive Pain in Chronic Low Back Pain
Izaya OGON ; Kouske IBA ; Hiroyuki TAKASHIMA ; Mitsunori YOSHIMOTO ; Tomonori MORITA ; Tsutomu OSHIGIRI ; Yoshinori TERASHIMA ; Makoto EMORI ; Atsushi TERAMOTO ; Tsuneo TAKEBAYASHI ; Toshihiko YAMASHITA
Asian Spine Journal 2021;15(4):441-446
Methods:
The participants were 50 patients with CLBP (23 men and 27 women; mean age, 63.1±17.8 years; range, 41–79 years). We compared the Visual Analog Scale (VAS) scores, intramyocellular lipids (IMCLs) and extramyocellular lipids (EMCLs) of the Mm in NocP and NeP groups, as evaluated with the Japanese NeP screening questionnaire.
Results:
The patients were categorized into the NocP (n=32) and NeP (n=18) groups. The mean VAS score of the NocP group was 59.3±3.1 mm and that of the NeP group was 73.6±4.6 mm. The mean VAS score was significantly higher in the NeP group as compared to that in the NocP group (p<0.01). As per the analysis of covariance for the VAS score, the mean IMCL levels of the Mm in the NocP and NeP groups were 722.3 mmol/L (95% confidence interval [CI], 611.4–833.1) and 484.8 mmol/L (95% CI, 381.1–588.5), respectively. The mean IMCL level was significantly higher in the NocP group than in the NeP group (p<0.05). The mean EMCL levels of the Mm for the NocP and NeP groups were 6,022.9 mmol/L (95% CI, 4,510.6–7,535.2) and 5,558.1 mmol/L (95% CI, 4,298.3–6,817.9), respectively; however, the difference was not significant (p=0.72).
Conclusions
The results indicated an association between the IMCL level of the Mm and NocP. Our results suggest that MRS of the Mm might be beneficial for the assessment of CLBP as well as appropriate targeted analgesic therapies.
6.Virtual Monochromatic Image Quality from Dual-Layer Dual-Energy Computed Tomography for Detecting Brain Tumors
Shota TANOUE ; Takeshi NAKAURA ; Yasunori NAGAYAMA ; Hiroyuki UETANI ; Osamu IKEDA ; Yasuyuki YAMASHITA
Korean Journal of Radiology 2021;22(6):951-958
Objective:
To evaluate the usefulness of virtual monochromatic images (VMIs) obtained using dual-layer dual-energy CT (DL-DECT) for evaluating brain tumors.
Materials and Methods:
This retrospective study included 32 patients with brain tumors who had undergone non-contrast head CT using DL-DECT. Among them, 15 had glioblastoma (GBM), 7 had malignant lymphoma, 5 had high-grade glioma other than GBM, 3 had low-grade glioma, and 2 had metastatic tumors. Conventional polychromatic images and VMIs (40–200 keV at 10 keV intervals) were generated. We compared CT attenuation, image noise, contrast, and contrast-to-noise ratio (CNR) between tumor and white matter (WM) or grey matter (GM) between VMIs showing the highest CNR (optimized VMI) and conventional CT images using the paired t test. Two radiologists subjectively assessed the contrast, margin, noise, artifact, and diagnostic confidence of optimized VMIs and conventional images on a 4-point scale.
Results:
The image noise of VMIs at all energy levels tested was significantly lower than that of conventional CT images (p < 0.05). The 40-keV VMIs yielded the best CNR. Furthermore, both contrast and CNR between the tumor and WM were significantly higher in the 40 keV images than in the conventional CT images (p < 0.001); however, the contrast and CNR between tumor and GM were not significantly different (p = 0.47 and p = 0.31, respectively). The subjective scores assigned to contrast, margin, and diagnostic confidence were significantly higher for 40 keV images than for conventional CT images (p < 0.01).
Conclusion
In head CT for patients with brain tumors, compared with conventional CT images, 40 keV VMIs from DL-DECT yielded superior tumor contrast and diagnostic confidence, especially for brain tumors located in the WM.
7.Virtual Monochromatic Image Quality from Dual-Layer Dual-Energy Computed Tomography for Detecting Brain Tumors
Shota TANOUE ; Takeshi NAKAURA ; Yasunori NAGAYAMA ; Hiroyuki UETANI ; Osamu IKEDA ; Yasuyuki YAMASHITA
Korean Journal of Radiology 2021;22(6):951-958
Objective:
To evaluate the usefulness of virtual monochromatic images (VMIs) obtained using dual-layer dual-energy CT (DL-DECT) for evaluating brain tumors.
Materials and Methods:
This retrospective study included 32 patients with brain tumors who had undergone non-contrast head CT using DL-DECT. Among them, 15 had glioblastoma (GBM), 7 had malignant lymphoma, 5 had high-grade glioma other than GBM, 3 had low-grade glioma, and 2 had metastatic tumors. Conventional polychromatic images and VMIs (40–200 keV at 10 keV intervals) were generated. We compared CT attenuation, image noise, contrast, and contrast-to-noise ratio (CNR) between tumor and white matter (WM) or grey matter (GM) between VMIs showing the highest CNR (optimized VMI) and conventional CT images using the paired t test. Two radiologists subjectively assessed the contrast, margin, noise, artifact, and diagnostic confidence of optimized VMIs and conventional images on a 4-point scale.
Results:
The image noise of VMIs at all energy levels tested was significantly lower than that of conventional CT images (p < 0.05). The 40-keV VMIs yielded the best CNR. Furthermore, both contrast and CNR between the tumor and WM were significantly higher in the 40 keV images than in the conventional CT images (p < 0.001); however, the contrast and CNR between tumor and GM were not significantly different (p = 0.47 and p = 0.31, respectively). The subjective scores assigned to contrast, margin, and diagnostic confidence were significantly higher for 40 keV images than for conventional CT images (p < 0.01).
Conclusion
In head CT for patients with brain tumors, compared with conventional CT images, 40 keV VMIs from DL-DECT yielded superior tumor contrast and diagnostic confidence, especially for brain tumors located in the WM.
8.Magnetic Resonance Spectroscopic Analysis of Multifidus Muscle Lipid Contents and Association with Nociceptive Pain in Chronic Low Back Pain
Izaya OGON ; Kouske IBA ; Hiroyuki TAKASHIMA ; Mitsunori YOSHIMOTO ; Tomonori MORITA ; Tsutomu OSHIGIRI ; Yoshinori TERASHIMA ; Makoto EMORI ; Atsushi TERAMOTO ; Tsuneo TAKEBAYASHI ; Toshihiko YAMASHITA
Asian Spine Journal 2021;15(4):441-446
Methods:
The participants were 50 patients with CLBP (23 men and 27 women; mean age, 63.1±17.8 years; range, 41–79 years). We compared the Visual Analog Scale (VAS) scores, intramyocellular lipids (IMCLs) and extramyocellular lipids (EMCLs) of the Mm in NocP and NeP groups, as evaluated with the Japanese NeP screening questionnaire.
Results:
The patients were categorized into the NocP (n=32) and NeP (n=18) groups. The mean VAS score of the NocP group was 59.3±3.1 mm and that of the NeP group was 73.6±4.6 mm. The mean VAS score was significantly higher in the NeP group as compared to that in the NocP group (p<0.01). As per the analysis of covariance for the VAS score, the mean IMCL levels of the Mm in the NocP and NeP groups were 722.3 mmol/L (95% confidence interval [CI], 611.4–833.1) and 484.8 mmol/L (95% CI, 381.1–588.5), respectively. The mean IMCL level was significantly higher in the NocP group than in the NeP group (p<0.05). The mean EMCL levels of the Mm for the NocP and NeP groups were 6,022.9 mmol/L (95% CI, 4,510.6–7,535.2) and 5,558.1 mmol/L (95% CI, 4,298.3–6,817.9), respectively; however, the difference was not significant (p=0.72).
Conclusions
The results indicated an association between the IMCL level of the Mm and NocP. Our results suggest that MRS of the Mm might be beneficial for the assessment of CLBP as well as appropriate targeted analgesic therapies.
9.Satisfaction Survey on Antipsychotic Formulations by Schizophrenia Patients in Japan
Masakazu HATANO ; Ippei TAKEUCHI ; Kanade YAMASHITA ; Aoi MORITA ; Kaori TOZAWA ; Takashi SAKAKIBARA ; Genta HAJITSU ; Manako HANYA ; Shigeki YAMADA ; Nakao IWATA ; Hiroyuki KAMEI
Clinical Psychopharmacology and Neuroscience 2021;19(4):610-617
Objective:
To identify factors affecting adherence to medication, a subjective questionnaire survey was administered to schizophrenia patients regarding the prescribed antipsychotic formulations.
Methods:
We evaluated the patients’ satisfaction and dissatisfaction with prescribed antipsychotic formulations, and patients answered the Drug Attitude Inventory-10 Questionnaire (DAI-10). Inclusion criteria for patients are as follows:age between 20 and 75 years and taking antipsychotic agents containing the same ingredients and formulations, for at least 1 month.
Results:
In total, 301 patients answered the questionnaire survey. Tablets were found to be the most commonly used antipsychotic formulations among schizophrenia patients (n = 174, 57.8%), followed by long-acting injections (LAIs, n = 93, 30.9%). No significant differences in the formulation satisfaction level and DAI-10 scores were observed between all formulations. Formulations, except for LAI, were selected by physicians in more than half of the patients.Patients who answered “Decided by consultation with physicians” had significantly higher satisfaction levels and DAI-10 scores compared to those who answered “Decided by physicians” (4.11 ± 0.77 vs. 3.80 ± 1.00, p = 0.0073 and 6.20 ± 3.51 vs. 4.39 ± 4.56, p < 0.001, respectively). Satisfaction levels moderately correlated with DAI-10 scores (r = 0.48, p < 0.001).
Conclusion
No formulation had a high satisfaction level in all patients, and it is important to be reflect the patients’ individual preferences in pharmacotherapy. Shared decision-making in the selection of the formulations is seen to be useful for improving medication adherence.
10.Is the Lipid Content of the Psoas Major Correlated with Chronic Low Back Pain and Spinopelvic Alignment? A Magnetic Resonance Spectroscopic Study
Izaya OGON ; Hiroyuki TAKASHIMA ; Tomonori MORITA ; Tsutomu OSHIGIRI ; Yoshinori TERASHIMA ; Mitsunori YOSHIMOTO ; Makoto EMORI ; Atsushi TERAMOTO ; Tsuneo TAKEBAYASHI ; Toshihiko YAMASHITA
Asian Spine Journal 2020;14(4):430-437
Methods:
The study population comprised 40 patients (19 males, 21 females; mean age, 61.7±2.4 years). Possible correlations of LBP Visual Analog Scale (VAS) scores, age, CSA, FI, and spinopelvic parameters with EMCL and IMCL contents of the psoas major were assessed.
Results:
No association was identified between the EMCL and IMCL contents and LBP VAS scores (r=0.05, p=0.79 and r=0.06, p=0.75, respectively). The EMCL content correlated with age (r=0.47, p<0.01), body mass index (BMI) (r=0.44, p<0.01), CSA (r=−0.59, p< 0.01), and FI (r=0.49, p<0.01). EMCL content showed a significant negative correlation with sacral slope (SS) (r=−0.43, p<0.05) and positive correlation with pelvic tilt (PT) (r=0.56, p<0.01).
Conclusions
EMCL content correlated with age, BMI, CSA, and FI of the psoas major, while IMCL content had no correlation. This study found correlations between SS and PT and EMCL content of the psoas major, but no correlations were found between spinopelvic parameters and IMCL content of the psoas major.

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