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.A Novel Mismatched PCR-Restriction Fragment Length Polymorphism Assay for Rapid Detection of gyrA and parC Mutations Associated With Fluoroquinolone Resistance in Acinetobacter baumannii
Naoki KAKUTA ; Ryuichi NAKANO ; Akiyo NAKANO ; Yuki SUZUKI ; Ayako TANOUCHI ; Takashi MASUI ; Saori HORIUCHI ; Shiro ENDO ; Risako KAKUTA ; Yasuo ONO ; Hisakazu YANO
Annals of Laboratory Medicine 2020;40(1):27-32
BACKGROUND:
Mutations in the quinolone resistance-determining regions (QRDRs) of Acinetobacter baumannii DNA gyrase (gyrA) and topoisomerase IV (parC) are linked to fluoroquinolone (FQ) resistance. We developed a mismatched PCR-restriction fragment length polymorphism (RFLP) assay to detect mutations in the gyrA and parC QRDRs associated with FQ resistance in A. baumannii.
METHODS:
Based on the conserved sequences of A. baumannii gyrA and parC, two primer sets were designed for mismatched PCR-RFLP to detect mutations in gyrA (codons 83 and 87) and parC (codons 80 and 84) by introducing an artificial restriction enzyme cleavage site into the PCR products. This assay was evaluated using 58 A. baumannii strains and 37 other Acinetobacter strains that have been identified by RNA polymerase β-subunit gene sequence analysis.
RESULTS:
PCR amplification of gyrA and parC was successful for all A. baumannii strains. In 11 FQ -susceptible strains, the gyrA and parC PCR products were digested by the selected restriction enzymes at the site containing gyrA (codons 83 and 87) and parC (codons 80 and 84). PCR products from 47 FQ-resistant strains containing mutations in gyrA and parC were not digested by the restriction enzymes at the site containing the mutation. As for the non-baumannii Acinetobacter strains, although amplification products for gyrA were obtained for 28 strains, no parC amplification product was obtained for any strain.
CONCLUSIONS
This assay specifically amplified gyrA and parC from A. baumannii and detected A. baumannii gyrA and parC mutations with FQ resistance.
5.Clinicopathologic features, treatment, prognosis and prognostic factors of neuroendocrine carcinoma of the endometrium: a retrospective analysis of 42 cases from the Kansai Clinical Oncology Group/Intergroup study in Japan
Harunobu MATSUMOTO ; Mototsugu SHIMOKAWA ; Kaei NASU ; Ayumi SHIKAMA ; Takaya SHIOZAKI ; Masayuki FUTAGAMI ; Kentaro KAI ; Hiroaki NAGANO ; Taisuke MORI ; Mitsutake YANO ; Norihiro SUGINO ; Etsuko FUJIMOTO ; Norihito YOSHIOKA ; Satoshi NAKAGAWA ; Muneaki SHIMADA ; Hideki TOKUNAGA ; Yuki YAMADA ; Tomohiko TSURUTA ; Kazuto TASAKI ; Ryutaro NISHIKAWA ; Shiho KUJI ; Takashi MOTOHASHI ; Kimihiko ITO ; Takashi YAMADA ; Norihiro TERAMOTO
Journal of Gynecologic Oncology 2019;30(6):e103-
OBJECTIVE: We conducted a retrospective, multi-institutional, collaborative study to accumulate cases of neuroendocrine carcinoma of the endometrium, to clarify its clinicopathologic features, treatment, prognosis and prognostic factors to collate findings to establish future individualized treatment regimens. To our knowledge, this is the largest case study and the first study to statistically analyze the prognosis of this disease. METHODS: At medical institutions participating in the Kansai Clinical Oncology Group/Intergroup, cases diagnosed at a central pathologic review as neuroendocrine carcinoma of the endometrium between 1995 and 2014 were enrolled. We retrospectively analyzed the clinicopathologic features, treatment, prognosis and prognostic factors of this disease. RESULTS: A total of 65 cases were registered from 18 medical institutions in Japan. Of these, 42 (64.6%) cases were diagnosed as neuroendocrine carcinoma of the endometrium based on the central pathological review and thus included in the study. Advanced International Federation of Gynecology and Obstetrics stages (stage III and IV) and pure type small cell neuroendocrine carcinoma cases had a significantly worse prognosis. Upon multivariate analysis, only histologic subtypes and surgery were significant prognostic factors. Pure type cases had a significantly worse prognosis compared to mixed type cases and complete surgery cases had a significantly better prognosis compared to cases with no or incomplete surgery. CONCLUSION: Our findings suggest that complete surgery improves the prognosis of neuroendocrine carcinoma of the endometrium. Even among cases with advanced disease stages, if complete surgery is expected to be achieved, clinicians should consider curative surgery to improve the prognosis of neuroendocrine carcinoma of the endometrium.
Carcinoma, Large Cell
;
Carcinoma, Neuroendocrine
;
Carcinoma, Small Cell
;
Endometrial Neoplasms
;
Endometrium
;
Female
;
Gynecology
;
Japan
;
Medical Oncology
;
Multivariate Analysis
;
Obstetrics
;
Prognosis
;
Retrospective Studies
6.Trough level of infliximab is useful for assessing mucosal healing in Crohn's disease: a prospective cohort study.
Akihiro KOGA ; Toshiyuki MATSUI ; Noritaka TAKATSU ; Yasumichi TAKADA ; Masahiro KISHI ; Yutaka YANO ; Takahiro BEPPU ; Yoichiro ONO ; Kazeo NINOMIYA ; Fumihito HIRAI ; Takashi NAGAHAMA ; Takashi HISABE ; Yasuhiro TAKAKI ; Kenshi YAO ; Hirotsugu IMAEDA ; Akira ANDOH
Intestinal Research 2018;16(2):223-232
BACKGROUND/AIMS: Decreased trough levels of infliximab (TLI) and antibodies to infliximab (ATI) are associated with loss of response (LOR) in Crohn's disease. Two prospective studies were conducted to determine whether TLI or ATI better correlates with LOR (Study 1), and whether TLI could become a predictor of mucosal healing (MH) (Study 2). METHODS: Study 1 was conducted in 108 patients, including those with LOR and remission to compare ATI and TLI in discriminating the 2 conditions based on receiver operating characteristic (ROC) curve analyses. Study 2 involved 35 patients who were evaluated endoscopically. RESULTS: In Study 1, there were no differences between the 2 assays in ROC curve analyses; the TLI cutoff value for LOR was 2.6 µg/mL (sensitivity, 70.9%; specificity, 79.2%), and the ATI cutoff value was 4.9 µg/mL (sensitivity, 65.5%; specificity, 67.9%). The AUROC (area under the ROC curve) of TLI was greater than that of ATI. AUROC was useful for discriminating between the 2 conditions. In Study 2, the TLI was significantly higher in the colonic MH group than in the non-MH group (2.7 µg/mL vs. 0.5 µg/mL, P=0.032). CONCLUSIONS: TLI is better than ATI for clinically diagnosing LOR, and a correlation was observed between TLI and colonic MH.
Antibodies
;
Cohort Studies*
;
Colon
;
Crohn Disease*
;
Humans
;
Infliximab*
;
Prospective Studies*
;
ROC Curve
;
Sensitivity and Specificity
7.Epidemiological Study of Erythromycin-Resistant Streptococcus pyogenes From Korea and Japan by emm Genotyping and Multilocus Sequence Typing.
Takashi TAKAHASHI ; Kazuaki ARAI ; Dong Hyun LEE ; Eun Ha KOH ; Haruno YOSHIDA ; Hisakazu YANO ; Mitsuo KAKU ; Sunjoo KIM
Annals of Laboratory Medicine 2016;36(1):9-14
BACKGROUND: We determined the epidemiological characteristics of erythromycin (EM)-resistant Streptococcus pyogenes (group A streptococci, GAS) strains isolated from Korea and Japan, using emm genotyping and multilocus sequence typing (MLST). METHODS: Clinical isolates of GAS had been collected from 1992 to 2012 in Korea and from 2004 to 2009 in Japan. EM resistance was determined by the microdilution method, and resistance genotypes were assessed by PCR. The emm genotyping and MLST were performed by DNA sequencing. RESULTS: The emm genotypes and sequence types (STs) were concordant in 143 (85.1%) of 168 EM-resistant GAS strains from Korea. ST36/emm12 (35.1%), ST52/emm28 (22.6%), and ST49/emm75 (16.1%) were the most common types. Most of the ST36 (93.9%) and ST52 (95.8%) strains harbored erm(B), whereas strains ST49, ST42, and ST15 contained mef(A). The concordance between emm genotypes and STs was 41 (93.2%) among 44 EM-resistant GAS strains from Japan. ST36/emm12 (34.1%), ST49/emm75 (18.2%), and ST28/emm1 (15.9%) were the major types. ST36 isolates harbored either erm(B) (56.3%) or mef(A) (37.5%), whereas isolates ST28, ST49, and ST38 carried only mef(A). The proportion of erm(B) and mef(A) was 66.1% and 33.3% in Korea and 22.7% and 68.2% in Japan, respectively. CONCLUSIONS: The common STs in Korea and Japan were ST36 and ST49, whereas ST52 was present only in Korea and ST28 only in Japan. Genotype erm(B) was predominant in Korea, whereas mef(A) was frequent in Japan. There were differences between Korea and Japan regarding the frequencies of emm genotypes, STs, and EM resistance genes among the EM-resistant GAS.
Anti-Bacterial Agents/*pharmacology/therapeutic use
;
Bacterial Proteins/*genetics
;
Bacterial Typing Techniques
;
*Drug Resistance, Bacterial
;
Epidemiologic Studies
;
Erythromycin/*pharmacology/therapeutic use
;
Genotype
;
Humans
;
Japan/epidemiology
;
Microbial Sensitivity Tests
;
Multilocus Sequence Typing
;
Republic of Korea/epidemiology
;
Streptococcal Infections/drug therapy/*microbiology
;
Streptococcus pyogenes/drug effects/*genetics/isolation & purification
8.Clinical analysis of influenza A (H1N1) pdm09
Keiko Yano ; Mizuho Nagao ; Ryoji Ichimi ; Toshiaki Ihara ; Takashi Nakano
An Official Journal of the Japan Primary Care Association 2013;36(3):160-165
Introduction : To clarify clinical features of influenza A (H1N1) pdm09, we analyzed patients admitted during the early stage of the pandemic.
Methods : Analysis covered pediatric patients hospitalized with this virus during the first 3 months of the pandemic.
Results : The patients (average age, 7.7 years) were older than those in previous analyses and were divided by the reason for admission. The group with respiratory complaints (39 patients) accounted for 40%, in contrast to 10% observed previously, and had a significantly high prevalence of bronchial asthma history (21 patients). Nine patients with dyspnea symptoms preceding fever experienced a shorter period (1.6 days) from onset to admission. These patients had elevated WBC counts (13644/µL) and longer hospitalization (6.0 days). Twenty-nine patients had false negative results in the initial rapid influenza diagnostic tests (RIDTs). Many of them belonged to the respiratory complaints group (20 patients) and developed pneumonia (15 patients). These patients required treatment other than that with anti-viral agents, e.g., oxygen therapy (18 patients), leading to longer hospitalization (4.5 days).
Conclusion : During the first 3 months of the pandemic, many patients were admitted with respiratory complaints. They had a high prevalence of bronchial asthma history. Patients with dyspnea symptoms preceding fever and those who were initially RIDT-negative required advanced treatments, resulting in longer hospitalization.
9.Reduction of the incidence of development of venous thromboembolism by ultrasound-guided femoral nerve block in total knee arthroplasty.
Yusuke ASAKURA ; Hiroki TSUCHIYA ; Hisatake MORI ; Takashi YANO ; Yasuhide KANAYAMA ; Hideki TAKAGI
Korean Journal of Anesthesiology 2011;61(5):382-387
BACKGROUND: Venous thromboembolism (VTE) and the subsequent development of pulmonary embolism (PE) is a major cause of post-operative mortality in total knee arthroplasty (TKA). We evaluated whether the addition of an ultrasound-guided femoral nerve block with general anesthesia affected the incidence in the development of VTE following TKA. METHODS: This was a retrospective non-randomized comparative study with patients assigned to groups based on the surgery date (pre-femoral nerve block versus post-femoral nerve block periods). All anesthesia and medical records of the patients who had undergone computer-navigated TKA in our facility between January 2009 and March 2010 were retrospectively reviewed. RESULTS: Forty patients were identified; 15 patients underwent computer-navigated TKA under general anesthesia alone (Group G) and 25 patients underwent surgery under general anesthesia combined with ultrasound-guided femoral nerve block (Group F). The incidence of development of VTE post-operatively was significantly lower in Group F (P = 0.037). Logistic regression analysis identified the use of a femoral nerve block as the most significant variable correlating with the incidence of post-operative development of VTE, and the odds ratio for VTE development in Group G was 3.12 (95% CI, 0.57-20.56). CONCLUSIONS: We suggest the possibility that the addition of a femoral nerve block on general anesthesia may reduce the incidence of the development of VTE following TKA.
Anesthesia
;
Anesthesia, General
;
Arthroplasty
;
Femoral Nerve
;
Humans
;
Incidence
;
Knee
;
Logistic Models
;
Medical Records
;
Nerve Block
;
Odds Ratio
;
Pulmonary Embolism
;
Retrospective Studies
;
Venous Thromboembolism


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