TY - JOUR
T1 - Short-term outcomes of colorectal stenting using a low axial force self-expandable metal stent for malignant colorectal obstruction
T2 - A japanese multicenter prospective study
AU - Sasaki, Takashi
AU - Yoshida, Shuntaro
AU - Isayama, Hiroyuki
AU - Narita, Akiko
AU - Yamada, Tomonori
AU - Enomoto, Toshiyuki
AU - Sumida, Yorinobu
AU - Kyo, Rika
AU - Kuwai, Toshio
AU - Tomita, Masafumi
AU - Moroi, Rintaro
AU - Shimada, Mamoru
AU - Hirata, Nobuto
AU - Saida, Yoshihisa
N1 - Funding Information:
Conflicts of Interest: T.S. received personal fees from Boston Scientific Japan, Co., Ltd., Century Medical, Inc., Cook Medical Japan, Kawasumi Laboratories, Inc., and Create Medic, Co., Ltd. S.Y. received personal fees from Boston Scientific Japan, Co., Ltd., Century Medical, Inc., Cook Medical Japan, and Olympus Medical Systems Co., Ltd. H.I. received personal fees from Boston Scientific Japan, Co., Ltd., Century Medical, Inc., TAEWOONG, Co., Ltd., FUJIFILM Healthcare, Co, Ltd., JAPAN LIFELINE, Co., Ltd., ZEON MEDICAL, Inc., Create Medic, Co., Ltd., Olympus, Co., Ltd., and Olympus Medical Science Sales Co., Ltd.; received research grants from Boston Scientific Japan, Co., Ltd., Century Medical, Inc., FUJIFILM Healthcare, Co., Ltd., and ZEON MEDICAL, Inc.; and received a guidance fee of technique from Kawasumi Laboratories, Inc. T.K. received personal fees from Boston Scientific Japan, Co., Ltd., Century Medical, Inc., and Japan Lifeline, Co., Ltd. Y.S. (Yoshihisa Saida) received personal fees from Boston Scientific Japan, Co., Ltd. and Century Medical, Inc.; received grants from Boston Scientific Japan, Co., Ltd., Century Medical, Inc., Japan Lifeline, Co., Ltd., Kawasumi Laboratories, Inc., Create Medic, Co., Ltd., Zeon Medical, Co., Ltd., Olympus Medical Systems, Co., Ltd., and FUJIFILM Healthcare, Co., Ltd.; and received consulting fees from Japan Lifeline, Co., Ltd., Olympus Medical Systems, Co., Ltd., and JIMPO, Co., Ltd. The other authors declare no conflicts of interest.
Funding Information:
Funding: This study was conducted with Japan Gastroenterological Endoscopy Society funding support, the Japanese Foundation for Research and Promotion of Endoscopy Grant, and the Colonic Stent Safe Procedure Research Group membership dues.
Funding Information:
This prospective, observational, single-arm, multicenter study was conducted by the Japan Colonic Stent Safe Procedure Research Group, which received support from the Japan Gastroenterological Endoscopy Society. Before starting this prospective study, this group had developed technical guidelines for safe colonic stenting (http://colon-stent.com/, accessed on 1 August 2021) and tried to share tips with the group members for stent placement and points to avoid complications. This study was conducted at 33 institutions (8 academic centers, 25 community hospitals) of these group members. The study was approved by the institutional review board at each institution. Written informed consent to undergo the procedure and participate in this study was obtained from each patient before the procedure. This study was registered in the University Hospital Medical Information Network Clinical Trial Registry (UMIN 000011304).
Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/11/1
Y1 - 2021/11/1
N2 - (1) Background: Endoscopic colorectal stenting with high technical success and safety is essential in discussing the oncological outcomes for the management of malignant colorectal obstruction. Mechanical properties of self-expandable metal stents are usually considered to affect clinical outcomes. (2) Methods: A multicenter, prospective study was conducted in Japan. A self-expandable metal stent with low axial force was inserted endoscopically. The primary endpoint was clinical success, defined as the resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events. Short-term outcomes of 7 days were evaluated in this study. (3) Results: Two hundred and five consecutive patients were enrolled. Three patients were excluded, and the remaining 202 patients were evaluated. The technical and clinical success rates were 97.5% and 96.0%, respectively. Major stent-related adverse events included stent migration (1.0%), insufficient stent expansion (0.5%), and stent occlusion (0.5%). No colonic perforation was observed. There were two fatal cases (1%) which were not related to stent placement. (4) Conclusions: The placement of self-expandable metal stents with low axial force is safe with no perforation and showed high technical and clinical success rates in short-term outcomes for the management of malignant colorectal obstruction.
AB - (1) Background: Endoscopic colorectal stenting with high technical success and safety is essential in discussing the oncological outcomes for the management of malignant colorectal obstruction. Mechanical properties of self-expandable metal stents are usually considered to affect clinical outcomes. (2) Methods: A multicenter, prospective study was conducted in Japan. A self-expandable metal stent with low axial force was inserted endoscopically. The primary endpoint was clinical success, defined as the resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events. Short-term outcomes of 7 days were evaluated in this study. (3) Results: Two hundred and five consecutive patients were enrolled. Three patients were excluded, and the remaining 202 patients were evaluated. The technical and clinical success rates were 97.5% and 96.0%, respectively. Major stent-related adverse events included stent migration (1.0%), insufficient stent expansion (0.5%), and stent occlusion (0.5%). No colonic perforation was observed. There were two fatal cases (1%) which were not related to stent placement. (4) Conclusions: The placement of self-expandable metal stents with low axial force is safe with no perforation and showed high technical and clinical success rates in short-term outcomes for the management of malignant colorectal obstruction.
KW - Axial force
KW - Malignant colorectal obstruction
KW - Safety
KW - Self-expandable metal stent
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U2 - 10.3390/jcm10214936
DO - 10.3390/jcm10214936
M3 - Article
AN - SCOPUS:85117938504
SN - 2077-0383
VL - 10
JO - Journal of Clinical Medicine
JF - Journal of Clinical Medicine
IS - 21
M1 - 4936
ER -