title: A randomized controlled trial of endoscopic steroid injection for prophylaxis of esophageal stenoses after extensive endoscopic submucosal dissection.
abstract: BACKGROUND
  Esophageal stenosis following endoscopic submucosal dissection (ESD) is a serious adverse event that makes subsequent management more difficult.
  
  
  METHODS
  This parallel, randomized, controlled, open-label study was designed to examine whether local steroid injection is an effective prophylactic treatment for esophageal stenoses following extensive ESD. This single center trial was conducted at the Keiyukai Hospital, a tertiary care center for gastrointestinal disease in Japan [University Hospital Medical Network Clinical Trial Registry (UMIN-CTR) on 15 September 2011 (UMIN000006327)]. Thirty-two patients with mucosal defects involving ≥75% of the esophageal circumference were randomized to receive a single dose of triamcinolone acetonide injections (n = 16) or be treated conventionally (n = 16). The primary outcome was the frequency of stricture requiring endoscopic dilatation; the surrogate primary endpoint was the number of dilatation sessions needed. Secondary outcomes included adverse event rates, the minimum diameter of the stenotic area and the duration of the course of dilatation treatments.
  
  
  RESULTS
  The frequency of stricture was not significantly different between the groups because of insufficient statistical power, but the number of dilatation sessions required was significantly less in the steroid group (6.1 sessions [95% confidence interval, CI 2.8-9.4] versus 12.5 [95% CI 7.1-17.9] sessions in the control group; P = 0.04). The perforation rate was similar in both groups. The minimum diameter of stenotic lumens was significantly greater in the treatment group than controls (11.0 mm versus 7.1 mm, respectively; P = 0.01). The perforation rate was not significantly different between the groups (1.0% versus 0.5% in the treatment and control group, respectively). Steroid injection was effective in cases of mucosal defects encompassing the entire esophageal circumference.
  
  
  CONCLUSIONS
  Prophylactic endoscopic steroid injection appears to be a safe means of relieving the severity of esophageal stenoses following extensive ESD.
authors.affiliation: Department of Gastroenterology, Keiyukai Daini Hospital, Hondori-13, Shiroishi-ku, Sapporo, 003-0027, Japan. takahashi@keiyukaisapporo.or.jp.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: Department of Gastroenterology, Rheumatology, and Clinical Immunology, Sapporo Medical University, S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan. arimura@sapmed.ac.jp.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Arimura
authors.affiliation: Department of Gastroenterology, Keiyukai Daini Hospital, Hondori-13, Shiroishi-ku, Sapporo, 003-0027, Japan. okaharas@comet.ocn.ne.jp.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Okahara
authors.affiliation: Department of Gastroenterology, Keiyukai Daini Hospital, Hondori-13, Shiroishi-ku, Sapporo, 003-0027, Japan. raidako.steps@nifty.com.
authors.forename: Junichi
authors.initials: J
authors.lastname: Kodaira
authors.affiliation: Department of Gastroenterology, Keiyukai Sapporo Hospital, Hondori-14, Shiroishi-ku, Sapporo, 003-0027, Japan. hokari@keiyukaisapporo.or.jp.
authors.forename: Kaku
authors.initials: K
authors.lastname: Hokari
authors.affiliation: Department of Gastroenterology, Keiyukai Sapporo Hospital, Hondori-14, Shiroishi-ku, Sapporo, 003-0027, Japan. tsukagoshi@keiyukaisapporo.or.jp.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tsukagoshi
authors.affiliation: Department of Gastroenterology, Rheumatology, and Clinical Immunology, Sapporo Medical University, S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan. shinomura@sapmed.ac.jp.
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Shinomura
authors.affiliation: Department of Surgery, Keiyukai Sapporo Hospital, Hondori-14, Shiroishi-ku, Sapporo, 003-0027, Japan. hosokawa@keiyukaisapporo.or.jp.
authors.forename: Masao
authors.initials: M
authors.lastname: Hosokawa
mesh_terms: D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000601:surgery*; D004106:Dilatation; D004210:Dissection / Q000009:adverse effects; D004938:Esophageal Neoplasms / Q000601:surgery*; D004939:Esophageal Perforation / Q000209:etiology; D004940:Esophageal Stenosis / Q000209:etiology / Q000517:prevention & control* / Q000628:therapy; D004945:Esophagoscopy; D005260:Female; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D009092:Mucous Membrane / Q000601:surgery; D014222:Triamcinolone Acetonide / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000893:Anti-Inflammatory Agents; D014222:Triamcinolone Acetonide