title: A phase II study of endoscopic submucosal dissection for superficial esophageal neoplasms (KDOG 0901).
abstract: BACKGROUND
  Most previous studies of endoscopic submucosal dissection (ESD) for superficial esophageal neoplasms were retrospective; prospective studies are scant.
  
  
  OBJECTIVE
  To prospectively assess the efficacy and safety of ESD for superficial esophageal neoplasms.
  
  
  METHODS
  Phase II study.
  
  
  METHODS
  University hospital.
  
  
  METHODS
  Fifty-two patients (median age 68 years; 48 men) who had a histologic diagnosis of superficial esophageal cancer without metastasis on CT or high-grade intraepithelial neoplasia (HGIN) were enrolled from April 2009 through November 2011.
  
  
  METHODS
  ESD was used to treat 56 lesions. All procedures were done by 4 endoscopists who each had previously performed ESD in more than 100 patients with gastric tumors.
  
  
  METHODS
  The primary endpoint was the R0 resection rate, and secondary endpoints were the safety and the rate of accurately diagnosing tumor depth on endoscopic examination.
  
  
  RESULTS
  The median treatment time was 69 minutes (24-168 minutes). The histopathologic diagnosis was squamous cell carcinoma in 49 lesions, HGIN in 5, and tubular adenocarcinoma in 2. The en bloc resection rate and R0 resection rate were 100% and 94.6%, respectively. The rates of adverse events during ESD and after ESD were 22.2% and 53.8%, respectively, but most events were mild. One patient (1.9%) had mediastinal emphysema without perforation. The rate of accurately diagnosing tumor depth on endoscopic examination was 76.8%.
  
  
  CONCLUSIONS
  Single-center, nonrandomized study.
  
  
  CONCLUSIONS
  Our study showed that ESD was an effective and relatively safe treatment for superficial esophageal neoplasms. ESD may be a useful treatment option for superficial esophageal neoplasms in hospitals with endoscopists who are experts in performing ESD for gastric tumors. (
  
  
  BACKGROUND
  UMIN000002047.).
authors.affiliation: Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Higuchi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanabe
authors.forename: Mizutomo
authors.initials: M
authors.lastname: Azuma
authors.forename: Chikatoshi
authors.initials: C
authors.lastname: Katada
authors.forename: Tohru
authors.initials: T
authors.lastname: Sasaki
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishido
authors.forename: Akira
authors.initials: A
authors.lastname: Naruke
authors.forename: Natsuya
authors.initials: N
authors.lastname: Katada
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery*; D000368:Aged; D000369:Aged, 80 and over; D002278:Carcinoma in Situ / Q000473:pathology / Q000601:surgery*; D002294:Carcinoma, Squamous Cell / Q000601:surgery*; D015331:Cohort Studies; D004210:Dissection / Q000379:methods*; D004938:Esophageal Neoplasms / Q000473:pathology / Q000601:surgery*; D004945:Esophagoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009092:Mucous Membrane / Q000601:surgery*; D060787:Neoplasm Grading; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: CO(2); ESD; HGIN; IT; NBI; SEN; SM1; SM2; carbon dioxide; deeper submucosal invasion (≥200 μm below the muscularis mucosae); endoscopic submucosal dissection; high-grade intraepithelial neoplasia; insulated-tip; minute submucosal invasion (<200 μm below the muscularis mucosae); narrow-band imaging; superficial esophageal neoplasm