title: Prospective trial of biodegradable stents for refractory benign esophageal strictures after curative treatment of esophageal cancer.
abstract: OBJECTIVE
  Biodegradable stents are reportedly effective for refractory benign esophageal strictures; however, little is known about their use in patients with refractory stricture after endoscopic submucosal dissection (ESD) or chemoradiotherapy (CRT) for esophageal cancer. This study aimed to evaluate the effectiveness of biodegradable stents for these patients.
  
  
  METHODS
  Patients with refractory benign esophageal stricture with a dysphagia score (DS) of 2 or worse and for whom the passage of a standard size endoscope was not possible were eligible. The primary endpoint was the proportion of those who improved their DSs (% DS improved) at 12 weeks after stent placement, and the secondary endpoints were the proportion of those who improved their DSs at 24 weeks, dysphagia-free survival (DFS), and adverse events.
  
  
  RESULTS
  Eighteen patients (men:women, 15:3; median age, 72 years; range, 53-80) were enrolled. Twelve patients improved their DS at 12 weeks (% DS improved, 66.7%; 90% CI, 44.6%-84.4%). Also, 8 of 11 patients (72.7%) after esophagectomy, 4 of 6 patients (66.7%) after ESD, and 3 of 4 patients (75%) after CRT improved at 12 weeks. Three patients who were treated with esophagectomy maintained their DS improvement at 24 weeks (% DS improved, 16.7%; 95% CI, 3.6%-41.4%). The median DFS was 14.1 weeks (95% CI, 13.0-19.0). One patient who had ESD and CRT developed an esophagobronchial fistula 3 months after stent placement.
  
  
  CONCLUSIONS
  Biodegradable stents are effective and tolerable for refractory benign esophageal strictures after treatment for esophageal cancer; however, long-term efficacy was limited, especially after ESD or CRT. (Clinical trial registration number: UMIN000008054.).
authors.affiliation: Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Yano
authors.affiliation: Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Yoda
authors.affiliation: Office of Clinical Research Support, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Nomura
authors.affiliation: Office of Clinical Research Support, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Kayo
authors.initials: K
authors.lastname: Toyosaki
authors.affiliation: Office of Clinical Research Support, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Hasegawa
authors.affiliation: Endoscopy Division, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ono
authors.affiliation: Endoscopy Division, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Tanaka
authors.affiliation: Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Morimoto
authors.affiliation: Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Horimatsu
authors.affiliation: Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Nonaka
authors.affiliation: Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kaneko
authors.affiliation: Office of Clinical Research Support, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Sato
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000369:Aged, 80 and over; D001983:Bronchial Fistula; D059248:Chemoradiotherapy / Q000009:adverse effects; D003680:Deglutition Disorders / Q000209:etiology / Q000503:physiopathology; D000069916:Endoscopic Mucosal Resection / Q000009:adverse effects; D004937:Esophageal Fistula; D004938:Esophageal Neoplasms / Q000628:therapy*; D004940:Esophageal Stenosis / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome