TY - JOUR
T1 - Comparison of hemostatic ability between spray coagulation and forced coagulation modes in endoscopic submucosal dissection in patients with early gastric neoplasms
T2 - a study protocol for multicenter randomized controlled trial (Spray-G trial)
AU - Maehara, Kosuke
AU - Esaki, Mitsuru
AU - Sumida, Yorinobu
AU - Yamaguchi, Daisuke
AU - Nishioka, Kei
AU - Homma, Hitoshi
AU - Inada, Taisuke
AU - Shiotsuki, Kazuo
AU - Fukuda, Shin Ichiro
AU - Akiho, Hirotada
AU - Nomura, Tadahiro
AU - Mizuta, Yumi
AU - Ishida, Satoshi
AU - Fujimoto, Shun
AU - Kimura, Shunichiro
AU - Tanaka, Yuichiro
AU - Hata, Kaori
AU - Shiga, Noriko
AU - Iwasa, Tsutomu
AU - Kimura, Yusuke
AU - Nakamura, Norimoto
AU - Suzuki, Yusuke
AU - Minoda, Yosuke
AU - Hata, Yoshitaka
AU - Ogino, Haruei
AU - Tagawa, Koshiro
AU - Ihara, Eikichi
AU - Ogawa, Yoshihiro
N1 - Publisher Copyright:
© 2024, The Author(s).
PY - 2024/12
Y1 - 2024/12
N2 - Background: Endoscopic submucosal dissection (ESD) is the standard treatment for early gastric neoplasms (EGN). Controlling intraoperative bleeding is crucial for ensuring safe and reliable procedures. ESD using the spray coagulation mode (SCM-ESD) has been developed to control bleeding more effectively than ESD using the conventional forced coagulation mode (FCM-ESD). This study aims to compare the hemostatic efficacies of SCM-ESD and FCM-ESD. Methods: This multicenter, prospective, parallel, randomized, open-label superiority trial will be conducted in five Japanese institutions. Patients with a preoperative diagnosis of intramucosal EGC will be randomized to undergo either SCM-ESD or FCM-ESD. The primary outcome measure is the completion of ESD with an electrosurgical knife alone, without the use of hemostatic forceps. Secondary outcomes include the number and duration of hemostasis using hemostatic forceps, procedure time, curability, and safety. A total of 130 patients will be enrolled in this study. Discussion: This trial will provide evidence on the hemostatic efficacy of SCM-ESD compared with FCM-ESD in patients with intramucosal EGN, potentially improving the safety and reliability of ESD procedures. Trial registration: The trial has been registered at the University Hospital Medical Information Network Clinical Trials Registration (UMIN-CTR) as UMIN000040518. The reception number is R000054009.
AB - Background: Endoscopic submucosal dissection (ESD) is the standard treatment for early gastric neoplasms (EGN). Controlling intraoperative bleeding is crucial for ensuring safe and reliable procedures. ESD using the spray coagulation mode (SCM-ESD) has been developed to control bleeding more effectively than ESD using the conventional forced coagulation mode (FCM-ESD). This study aims to compare the hemostatic efficacies of SCM-ESD and FCM-ESD. Methods: This multicenter, prospective, parallel, randomized, open-label superiority trial will be conducted in five Japanese institutions. Patients with a preoperative diagnosis of intramucosal EGC will be randomized to undergo either SCM-ESD or FCM-ESD. The primary outcome measure is the completion of ESD with an electrosurgical knife alone, without the use of hemostatic forceps. Secondary outcomes include the number and duration of hemostasis using hemostatic forceps, procedure time, curability, and safety. A total of 130 patients will be enrolled in this study. Discussion: This trial will provide evidence on the hemostatic efficacy of SCM-ESD compared with FCM-ESD in patients with intramucosal EGN, potentially improving the safety and reliability of ESD procedures. Trial registration: The trial has been registered at the University Hospital Medical Information Network Clinical Trials Registration (UMIN-CTR) as UMIN000040518. The reception number is R000054009.
KW - Endoscopic submucosal dissection
KW - Gastric neoplasms
KW - Hemostasis
KW - Spray coagulation mode
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UR - http://www.scopus.com/inward/citedby.url?scp=85182491478&partnerID=8YFLogxK
U2 - 10.1186/s13063-023-07852-6
DO - 10.1186/s13063-023-07852-6
M3 - Article
C2 - 38225659
AN - SCOPUS:85182491478
SN - 1745-6215
VL - 25
JO - Trials
JF - Trials
IS - 1
M1 - 53
ER -