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.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
5.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.