Moroi Rintaro, Shiga Hisashi, Nochioka Kotaro, Shimoyama Yusuke, Kuroha Masatake, Kakuta Yoichi, Kinouchi Yoshitaka, Masamune Atsushi
Division of Gastroenterology, Tohoku University Hospital, 1-1, Seiryo, Aoba, Sendai, Miyagi, 980-8574, Japan.
Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Miyagi, Japan.
Pilot Feasibility Stud. 2022 Apr 19;8(1):85. doi: 10.1186/s40814-022-01046-8.
Small benign intestinal stenosis is usually treated by endoscopic balloon dilation (EBD) or surgery. Although EBD and surgery are able to resolve the stenosis in most cases, they are associated with several problems such as insufficient dilation and surgical stress, respectively. On the contrary, a novel approach called radial incision and cutting (RIC) is reported to have several benefits when compared to EBD and surgery. We can currently adopt RIC only for the strictures in the colon or terminal ileum and not for those stenotic lesions present further in the small intestine where balloon-assisted endoscopy is utilized, because the long-type electric knife is currently not approved for use in Japan. We will herein conduct a pilot study to investigate the safety and feasibility of RIC for treating the benign stenoses of the small intestine using the long-type electric knife.
This will be a single-center, single-arm, interventional trial. The major criteria for inclusion will be age ranging from 20 to 80 years and the presence of benign stenosis in the small intestine. We will perform RIC on 10 participants. The primary outcome is the safety of this procedure, which will be assessed by measuring the frequency of adverse events of special interest. The secondary outcomes will be technical success rate, improvement in subjective symptoms, procedure time, and duration of hospitalization.
This pilot study will provide useful information that will aid in adopting RIC for treating the benign strictures present in the small intestine.
jRCT Identifier, jRCTs022200040 . Registered on 1 March 2021.
小型良性肠道狭窄通常通过内镜球囊扩张术（EBD）或手术治疗。尽管EBD和手术在大多数情况下能够解决狭窄问题，但它们分别存在一些问题，如扩张不足和手术应激。相反，与EBD和手术相比，一种名为径向切开与切割（RIC）的新方法据报道有诸多益处。目前在日本，由于长型电刀未获批准使用，我们只能将RIC用于结肠或回肠末端的狭窄，而不能用于小肠更深处使用球囊辅助内镜的狭窄病变。我们在此将进行一项前瞻性研究，以调查使用长型电刀进行RIC治疗小肠良性狭窄的安全性和可行性。
这将是一项单中心、单臂干预性试验。纳入的主要标准将是年龄在20至80岁之间且小肠存在良性狭窄。我们将对10名参与者进行RIC。主要结局是该手术的安全性，将通过测量特别关注的不良事件发生率来评估。次要结局将是技术成功率、主观症状改善情况、手术时间和住院时长。
这项前瞻性研究将提供有用信息，有助于采用RIC治疗小肠存在的良性狭窄。
日本注册临床试验标识符，jRCTs022200040。于2021年3月1日注册。
