title: An open-label, prospective trial of cryospray ablation for Barrett's esophagus high-grade dysplasia and early esophageal cancer in high-risk patients.
abstract: BACKGROUND
  Endoscopic ablation of Barrett's esophagus (BE) is a treatment option for patients with high-grade dysplasia (HGD) and intramucosal carcinoma (IMCA).
  
  
  OBJECTIVE
  To assess the safety and efficacy of a unique noncontact method of liquid nitrogen cryoablation as measured by histologic response rate and cancer-free survival.
  
  
  METHODS
  Single-center, nonrandomized cohort study.
  
  
  METHODS
  Referral center, conducted between September 2005 and September 2008.
  
  
  METHODS
  Patients with BE and HGD or IMCA who were deemed inoperable or who refused esophagectomy. Age, length of BE, and previous ablation were not exclusion criteria.
  
  
  METHODS
  Cryoablation every 6 weeks until endoscopic resolution. EMR was used for pathologic staging of nodular areas before cryoablation and focal residual areas during the follow-up period.
  
  
  METHODS
  Histologic response was defined by the worst pathology obtained at any level of the esophagus or gastric cardia in 1 of 3 categories: (1) incremental = absence of HGD and IMCA in all biopsy specimens, (2) partial = residual IMCA with absence of any dysplasia, and (3) complete = absence of any intestinal metaplasia or dysplasia.
  
  
  RESULTS
  Thirty patients underwent ablation; 9 had undergone previous ablation or mucosectomy. Twenty-seven of 30 patients (90%) had downgrading of pathology stage after treatment. Elimination of cancer or downgrading of HGD at last follow-up was 68% for HGD and 80.0% for IMCA, with a median follow-up period of 12 months (25th percentile, 6; 75th percentile, 24). Minor adverse events included mild pain (n = 7), a low incidence of mild strictures (n = 3), and lip ulcer (n = 1). One major adverse event (perforation) in a patient with Marfan syndrome occurred with the prototype system. During follow-up, 3 of 6 patients with complete response had recurrence of dysplasia or cancer in the gastric cardia.
  
  
  CONCLUSIONS
  A nonrandomized, single-center study with a heterogeneous cohort of patients.
  
  
  CONCLUSIONS
  Patients with BE and HGD or IMCA have a positive response to endoscopic cryotherapy at 1-year follow-up.
authors: Departments of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, Ohio, USA. dumotj@ccf.org
authors: John A
authors: JA
authors: Dumot
authors: John J
authors: JJ
authors: Vargo
authors: Gary W
authors: GW
authors: Falk
authors: Lorraine
authors: L
authors: Frey
authors: Rocio
authors: R
authors: Lopez
authors: Thomas W
authors: TW
authors: Rice
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001471:Barrett Esophagus / Q000473:pathology / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D015331:Cohort Studies; D003452:Cryosurgery / Q000379:methods*; D004938:Esophageal Neoplasms / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies