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 method for determining dose distribution on panoramic reconstruction computed tomography images from radiotherapy computed tomography
Hiroyuki OKAMOTO ; Madoka SAKURAMACHI ; Wakako YATSUOKA ; Takao UENO ; Kouji KATSURA ; Naoya MURAKAMI ; Satoshi NAKAMURA ; Kotaro IIJIMA ; Takahito CHIBA ; Hiroki NAKAYAMA ; Yasunori SHUTO ; Yuki TAKANO ; Yuta KOBAYASHI ; Hironori KISHIDA ; Yuka URAGO ; Masato NISHITANI ; Shuka NISHINA ; Koushin ARAI ; Hiroshi IGAKI
Imaging Science in Dentistry 2024;54(2):129-137
Purpose:
Patients with head and neck cancer (HNC) who undergo dental procedures during radiotherapy (RT) face an increased risk of developing osteoradionecrosis (ORN). Accordingly, new tools must be developed to extract critical information regarding the dose delivered to the teeth and mandible. This article proposes a novel approach for visualizing 3-dimensional planned dose distributions on panoramic reconstruction computed tomography (pCT) images.
Materials and Methods:
Four patients with HNC who underwent volumetric modulated arc therapy were included. One patient experienced ORN and required the extraction of teeth after RT. In the study approach, the dental arch curve (DAC) was defined using an open-source platform. Subsequently, pCT images and dose distributions were generated based on the new coordinate system. All teeth and mandibles were delineated on both the original CT and pCT images. To evaluate the consistency of dose metrics, the Mann-Whitney U test and Student t-test were employed.
Results:
A total of 61 teeth and 4 mandibles were evaluated. The correlation coefficient between the 2 methods was 0.999, and no statistically significant difference was observed (P>0.05). This method facilitated a straightforward and intuitive understanding of the delivered dose. In 1 patient, ORN corresponded to the region of the root and the gum receiving a high dosage (approximately 70 Gy).
Conclusion
The proposed method particularly benefits dentists involved in the management of patients with HNC. It enables the visualization of a 3-dimensional dose distribution in the teeth and mandible on pCT, enhancing the understanding of the dose delivered during RT.
5.Selective Inhibition of β-Catenin/Co-Activator Cyclic AMP Response Element-Binding Protein-Dependent Signaling Prevents the Emergence of Hapten-Induced Atopic Dermatitis-Like Dermatitis
Haruna MATSUDA-HIROSE ; Tomoko YAMATE ; Mizuki GOTO ; Akira KATOH ; Hiroyuki KOUJI ; Yuya YAMAMOTO ; Takashi SAKAI ; Naoto UEMURA ; Takashi KOBAYASHI ; Yutaka HATANO
Annals of Dermatology 2019;31(6):631-639
BACKGROUND: The canonical Wnt/β-catenin signaling pathway is a fundamental regulatory system involved in various biological events. ICG-001 selectively blocks the interaction of β-catenin with its transcriptional co-activator cyclic AMP response element-binding protein (CBP). Recent studies have provided convincing evidence of the inhibitory effects of ICG-001 on Wnt-driven disease models, such as organ fibrosis, cancer, acute lymphoblastic leukemia, and asthma. However, the effects of ICG-001 in atopic dermatitis (AD) have not been investigated. OBJECTIVE: To investigate whether β-catenin/CBP-dependent signaling was contributed in the pathogenesis of AD and ICG-001 could be a therapeutic agent for AD. METHODS: We examined the effects of ICG-001 in an AD-like murine model generated by repeated topical application of the hapten, oxazolone (Ox). ICG-001 or vehicle alone was injected intraperitoneally every day during the development of AD-like dermatitis arising from once-daily Ox treatment. RESULTS: Ox-induced AD-like dermatitis characterized by increases in transepidermal water loss, epidermal thickness, dermal thickness accompanied by increased myofibroblast and mast cell counts, and serum levels of thymic stromal lymphopoietin and thymus and activation-regulated chemokine, and decreases in stratum corneum hydration, were virtually normalized by the treatment with ICG-001. Elevated serum levels of periostin tended to be downregulated, without statistical significance. CONCLUSION: These results suggest that β-catenin/CBP-dependent signaling might be involved in the pathogenesis of AD and could be a therapeutic target.
Animals
;
Asthma
;
Chemokine CCL17
;
Cyclic AMP Response Element-Binding Protein
;
Cyclic AMP
;
Dermatitis
;
Dermatitis, Atopic
;
Fibrosis
;
Mast Cells
;
Mice
;
Myofibroblasts
;
Oxazolone
;
Precursor Cell Lymphoblastic Leukemia-Lymphoma
;
Water
6.Is repeated high-dose medroxyprogesterone acetate (MPA) therapy permissible for patients with early stage endometrial cancer or atypical endometrial hyperplasia who desire preserving fertility?.
Wataru YAMAGAMI ; Nobuyuki SUSUMU ; Takeshi MAKABE ; Kensuke SAKAI ; Hiroyuki NOMURA ; Fumio KATAOKA ; Akira HIRASAWA ; Kouji BANNO ; Daisuke AOKI
Journal of Gynecologic Oncology 2018;29(2):e21-
OBJECTIVE: Reports on the repeated administration of medroxyprogesterone acetate (MPA) for intrauterine recurrence after fertility-preserving therapy for atypical endometrial hyperplasia (AEH) and early grade 1 endometrioid carcinoma (G1) are lacking. We aimed to clarify the outcomes of repeated MPA therapy in cases of intrauterine recurrence after fertility-preserving therapy with MPA against AEH/early G1. METHODS: Patients with AEH or stage IA well-differentiated endometrioid carcinoma without myometrial invasion who underwent first-line MPA therapy for primary lesions or intrauterine recurrence were divided into initial treatment and repeated treatment groups (162 and 82 patients, respectively). Oral MPA administration (400−600 mg/day) was continued until pathological tumor disappearance. Data regarding clinicopathological factors, adverse events, and outcomes following the initial and repeated hormonal treatments were extracted from medical records and analyzed. RESULTS: Complete response rates in the initial and repeated treatment groups were 98.5% and 96.4%, respectively, among patients with AEH, and were 90.7% and 98.1%, respectively, among patients with G1. In the initial treatment group, 5-year recurrence-free survival (RFS) rates were 53.7% and 33.2% among patients with AEH and G1, respectively. In the repeated treatment group, RFS rates were 14.0% and 11.2% among patients with AEH and G1, respectively. Among patients with AEH, the pregnancy rate tended to be lower in the repeated treatment group than in the initial treatment group (11.1% vs. 29.2%; p=0.107), while no significant group difference was observed among patients with G1 (20.8% vs. 22.7%). CONCLUSION: Repeated treatment is sufficiently effective for intrauterine recurrence after hormonal therapy for AEH/early G1.
Carcinoma, Endometrioid
;
Endometrial Hyperplasia*
;
Endometrial Neoplasms*
;
Female
;
Fertility Preservation
;
Fertility*
;
Hormone Replacement Therapy
;
Humans
;
Medical Records
;
Medroxyprogesterone Acetate*
;
Medroxyprogesterone*
;
Pregnancy Rate
;
Recurrence
7.A Case of Aortic Subannular Left Ventricular Aneurysm with Bicuspid Aortic Valve Stenosis
Takahiro Shigaki ; Tohru Takaseya ; Satoshi Kikusaki ; Takahiro Syojima ; Kumiko Wada ; Kouji Akasu ; Kouichi Arinaga ; Hiroyuki Tanaka
Japanese Journal of Cardiovascular Surgery 2016;45(4):187-191
A 69-year-old woman was given a diagnosis of moderate aortic stenosis (AS) associated with congenital bicuspid valve in 2011. In 2014, surgery was indicated because of progression of AS and dilatation of the sinus of Valsalva and ascending aorta. Preoperative contrast-enhanced CT and echocardiography showed the saccular space (2×2 cm) located at the left ventricular outflow tract just below the aortic annulus. At surgery, the saccular aneurysm was located just below the aortic annulus of the noncoronary cusp. We resected the aneurysm and closed the orifice with interrupted sutures from the inside of the LV and the outside. Aortic subannular left ventricular aneurysm is a very rare malformation with only 25 reported cases and its natural course is largely unknown. Rupture of aneurysms, infection, thrombus formation, arrhythmia, and heart failure etc. has been reported as complications. We reported a case of aortic subannular left ventricular aneurysm with bicuspid aortic valve stenosis with a literature review.
8.A Case of Aortic Valve Papillary Fibroelastoma with Atrial Septal Defect
Hideaki Kanda ; Yosuke Hisashi ; Hiroyuki Yamamoto ; Kouji Tao ; Yoshiya Shigehisa ; Hirokazu Kawazu ; Bunsei Yamamoto ; Yutaka Imoto
Japanese Journal of Cardiovascular Surgery 2013;42(2):148-150
A 68-year-old woman with a diagnosis of atrial septal defect (ASD) presented with dyspnea. Chest radiography demonstrated cardiomegaly and infiltration in both lungs, suggestive of cardiac decompensation due to ASD. Detailed evaluation with transthoracic echocardiography revealed a mobile tumor on the aortic valve. Intraoperatively, tumors were identified on all aortic cusps. Preservation of the aortic valve was difficult. We therefore performed aortic valve replacement and patch closure of the ASD. The existing literature suggests that mobile papillary fibroelastoma should be excised irrespective of size, to prevent the risk of embolism. Excision of the tumor alone is usually sufficient. However, the present case showed clustered tumors on the aortic valve, so preservation of the cusps could not be achieved in this case.
9.Comparison of Early and Midterm Result of Endovascular Aneurysm Repair and Open Repair in the Treatment of Abdominal Aortic Aneurysms
Yoshifumi Iguro ; Hiroyuki Yamamoto ; Kenichi Arata ; Akira Kobayashi ; Masahiro Ueno ; Kouji Tao ; Syouichi Suehiro ; Ryuzo Sakata
Japanese Journal of Cardiovascular Surgery 2005;34(6):395-400
To evaluate a comparison for endovascular repair (EVAR) versus open repair (OR) for the treatment of abdominal aortic aneurysm (AAA). Data of all patients with infrarenal AAA treated electively, both with OR (107 cases) and EVAR (24 cases), at our institute between January 1999 and March 2004 were retrospectively reviewed. No difference was found between the 2 groups for sex, age, and AAA size. Cases of chronic obstructive pulmonary disease (20.8% vs 6.5%, p<0.04) and frequencies of laparotomy (25% vs 2.8%, p<0.001) were significantly more in the EVAR group than the OR group. In the initial results, deployment of the stent grafts was successful in all cases and complete thrombosis of the aneurysm was achieved in 21 cases (87.5%). One graft occlusion and a wound infection occurred in the EVAR group. OR was successfully performed in all cases. These were 6 cases of paralytic ileus, 1 of re-operation for hemorrhage, 1 of respiratory failure, and 1 of ischemic colitis in the OR group. One hospital death occurred in each group. Mean blood transfusion (0ml vs 238±345ml) and operation time (131±53min vs 250±76min) were significantly less in the EVAR group than the OR group. In the long term results, the cumulative survival rate was 88.0±6.5% at 1 and 2 years, 80.6±9.2% at 3 years in the EVAR group; 99.0±0.9% at 1 year, 94.1±2.6% at 2 years, 87.7±3.9% at 3 years in the OR group, with no difference between the 2 groups regarding survival rate. Four new endoleak and 3 graft infections were encountered in the EVAR group. Freedom from stent graft-related complications was 81.3±8.5% at 1 year, 61.4±11.9% at 2 years, 47.8±12.6% at 3 years in the EVAR group, but 100% at 1, 2 and 3 years in the OR group. Freedom from procedure-related complications in the EVAR group was significantly lower than that in OR group. In the long term results, EVAR was associated with more procedure-related complications. This finding may justify reappraisal of currently accepted EVAR for AAA management strategies.
10.Blood Conservation in Open-Heart Surgery. Avoiding Predonated Autologous Blood.
Hiroshi Osawa ; Kouji Tsuchiya ; Hiroyuki Saito ; Hiroshi Furukawa ; Youhei Kabuto ; Yoshinao Iida
Japanese Journal of Cardiovascular Surgery 2000;29(2):63-67
Background: Operative blood loss during open-heart surgery has been decreasing recently. We have stopped predonated autologous blood transfusions to reduce hospital stay and cost. Material and methods: In 70 consecutive elective open-heart cases, we used intraoperative hemodilutional autologous transfusions and intraoperative autotransfusions to avoid homologous blood transfusion. Predonated autologous blood transfusion was not used. All patients received an infusion of high-dose tranexamic acid prior to and after cardiopulmonary bypass (CPB). Results: Homologous blood transfusion was not required in 77.1% of patients who underwent open-heart surgery. When further classified, 84.5% of patients who underwent primary open-heart surgery, 41.7% of patients who underwent a reoperation, and 33.3% of patients who were preoperatively anemic did not require homologous blood transfusion. In patients who undergo reoperation and who are preoperatively anemic, the rate of homologous blood transfusion is high. Therefore, during the reoperation, intraoperative autologous blood transfusion should be used before starting CPB, and iron should be given to anemic patients prior to reoperation. Conclusion: Our strategy of blood conservation consists of intraoperative hemodilutional autologous transfusion, intraoperative autotransfusion, infusion of high-dose tranexamic acid prior to and after CPB and, avoiding predonated autologous blood transfusion. Based on our experience, predonated autologous blood transfusion is usually unnecessary for cases who undergo surgery for the first time and are not anemic. Predonated autologous blood transfusion should be reserved only for high risk patients with anemia and reoperation cases. For further blood conservation, we need to study the safety limits of non-transfusion in open-heart surgery.


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