Minoda Yosuke, Ogino Haruei, Sumida Yorinobu, Osoegawa Takashi, Itaba Soichi, Hashimoto Norikazu, Esaki Mitsuru, Kitagawa Yusuke, Yodoe Kentaro, Iboshi Yoichiro, Matsuguchi Takahiro, Tadokoro Mei, Chaen Tomohito, Kubo Hiroaki, Kubokawa Masaru, Harada Naohiko, Nishizima Kenichi, Fujii Hiroyuki, Hata Yoshitaka, Tanaka Yoshimasa, Ihara Eikichi, Ogawa Yoshihiro
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Gastroenterology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Therap Adv Gastroenterol. 2022 Jan 13;15:17562848211065331. doi: 10.1177/17562848211065331. eCollection 2022.
The colonic self-expandable metallic stent (C-SEMS) with a 9-French (Fr) delivery system allows for a small-caliber endoscope (SCE) to be used to treat malignant colonic obstruction. Despite the lack of evidence, the SCE has become popular because it is considered easier to insert than the large-caliber endoscope (LCE). We aimed to determine whether the SCE is more suitable than the LCE for C-SEMS placement.
Between July 2018 and November 2019, 50 consecutive patients who were scheduled to undergo C-SEMS for colon obstruction were recruited in this study. Patients were randomized to the SCE or LCE group. The SCE and LCE were used with 9-Fr and 10-Fr delivery systems, respectively. The primary outcome was the total procedure time. Secondary outcomes were the technical success rate, complication rate, clinical success rate, insertion time, guidewire-passage time, stent-deployment time, and colonic obstruction-scoring-system score.
Forty-five patients (SCE group, = 22; LCE group, = 23) were analyzed. The procedure time in the LCE group (median, 20.5 min) was significantly ( = 0.024) shorter than that in the SCE group (median, 25.1 min). The insertion time in the LCE group (median, 2.0 min) was significantly ( = 0.0049) shorter than that in the SCE group (median, 6.0 min). A sub-analysis of the procedure difficulties showed that the insertion time in the LCE group (median, 5.0 min) was significantly shorter than that in the SCE group (median, 8.5 min).
Both LCE and SCE can be used for C-SEMS; however, LCE is more suitable than SCE as it achieved a faster and equally efficacious C-SEMS placement as that of SCE.
University Hospital Medical Information Network Clinical Trials Registry (UMIN 32748).
采用9法式(Fr)输送系统的结肠自膨式金属支架(C-SEMS)允许使用小口径内镜(SCE)治疗恶性结肠梗阻。尽管缺乏证据,但SCE因其被认为比大口径内镜(LCE)更容易插入而受到欢迎。我们旨在确定SCE在放置C-SEMS方面是否比LCE更合适。
在2018年7月至2019年11月期间,本研究招募了50例计划接受C-SEMS治疗结肠梗阻的连续患者。患者被随机分为SCE组或LCE组。SCE和LCE分别与9-Fr和10-Fr输送系统配合使用。主要结局是总操作时间。次要结局包括技术成功率、并发症发生率、临床成功率、插入时间、导丝通过时间、支架展开时间和结肠梗阻评分系统评分。
分析了45例患者(SCE组,n = 22;LCE组,n = 23)。LCE组的操作时间(中位数,20.5分钟)显著短于SCE组(中位数,25.1分钟)(P = 0.024)。LCE组的插入时间(中位数, 2.0分钟)显著短于SCE组(中位数,6.0分钟)(P = 0.0049)。对操作难度的亚组分析显示,LCE组的插入时间(中位数,5.0分钟)显著短于SCE组(中位数,8.5分钟)。
LCE和SCE均可用于放置C-SEMS;然而,LCE比SCE更合适,因为它在放置C-SEMS时速度更快且效果与SCE相当。
大学医院医学信息网络临床试验注册中心(UMIN 32748)