Original articleClinical endoscopyA Japanese prospective multicenter study of self-expandable metal stent placement for malignant colorectal obstruction: short-term safety and efficacy within 7 days of stent procedure in 513 cases
Section snippets
Study design
This prospective, observational, single-arm multicenter clinical trial was conducted from March 2012 to October 2013. This study was registered with the University Hospital Medical Information Network Clinical Trial Registry (UMIN000007953). Before study startup, a Web site (http://colon-stent.com/) was launched, and the standard methods of SEMS placement, based on previously published data, were posted.15, 18, 19 Furthermore, we established the Colonic Stent Safe Procedure Research Group of
Results
A flowchart of the patient registry is shown in Figure 1. A total of 518 consecutive patients were enrolled in the study. Five patients were excluded because of loose stenosis identified on colonoscopy (n = 3), adhesive small-bowel obstruction (n = 1), and placement of another type of SEMS (n = 1). The per-protocol cohort comprised the remaining 513 patients. Treatment intent was BTS in 312 patients (60.8%) and PAL in 201 patients (39.2%). During the 7-day follow-up, BTS and PAL outcomes were
Discussion
To our knowledge, the current study is the largest prospective, multicenter feasibility study of SEMSs to date. Our results have clarified the following points: (1) extrinsic tumor origin is independently associated with the clinical failure of SEMS after stent placement and (2) the main causes of early perforation (within 7 days of stent placement) are stent procedure and SEMS placement in patients with comorbidities (obstructive colitis or impending perforation) not apparent before stent
Acknowledgments
The authors acknowledge Miyuki Tsuchida (Department of Gastroenterology, The University of Tokyo) for her role as clinical study coordinator and data manager, Masafumi Yanagisawa for his assistance in Web site management, Editage (www.editage.jp) for English language editing, and Tomoyuki Kawada for his assistance in the statistical analyses.
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2022, Acta BiomaterialiaCitation Excerpt :Once the stent migrates, patients are required to accept stent removal and secondary implantation, increasing their suffering [5]. Migrated stents may also induce intestinal perforation, threatening the patient's life [11]. Structural modifications, such as flared ends, anchoring flaps, double coating layers, and surface adhesion, have been widely used to prevent migration but have shown limited improvements [12–17].
DISCLOSURE: Dr Matsu has received personal fees from Boston Scientific Japan. Dr Yoshida has received personal fees from Boston Scientific Japan, Century Medical Inc, and ZEON. Dr Isayama has received donations and fees from Boston Scientific Japan, Century Medical Inc, and Taewong Medical. Dr Kuwai has received personal fees from Boston Scientific Japan, Dr Maetani has received personal frees from Boston Scientific Japan, Century Medical Inc, Piolax Medical Devices, and MC Medica. Dr Shimada has received personal fees from Boston Scientific Japan. Dr Saito has received personal fees from Boston Scientific Japan and Century Medical Inc. Dr Koizuma has received personal fees from Century Medical Inc and Olympus Medical Systems. Dr Sasaki has received personal fees from Boston Scientific Japan and Piolax Medical Devices. Dr Saida has received grants and personal fees from Boston Scientific Japan, Century Medical Inc, and Olympus Medical Systems. All other authors disclosed no financial relationships relevant to this publication.
See CME section; p. 718.