title: Minimally invasive esophagectomy: results of a prospective phase II multicenter trial-the eastern cooperative oncology group (E2202) study.
abstract: OBJECTIVE
  The primary aim of this trial was to assess the feasibility of minimally invasive esophagectomy (MIE) in a multi-institutional setting.
  
  
  BACKGROUND
  Esophagectomy is an important, potentially curative treatment for localized esophageal cancer, but is a complex operation. MIE may decrease the morbidity and mortality of resection, and single-institution studies have demonstrated successful outcomes with MIE.
  
  
  METHODS
  We conducted a multicenter, phase II, prospective, cooperative group study (coordinated by the Eastern Cooperative Oncology Group) to evaluate the feasibility of MIE. Patients with biopsy-proven high-grade dysplasia or esophageal cancer were enrolled at 17 credentialed sites. Protocol surgery consisted of either 3-stage MIE or Ivor Lewis MIE. The primary end point was 30-day mortality. Secondary end points included adverse events, duration of hospital-stay, and 3-year outcomes.
  
  
  RESULTS
  Protocol surgery was completed in 95 of the 104 patients eligible for the primary analysis (91.3%). The 30-day mortality in eligible patients who underwent MIE was 2.1%; perioperative mortality in all registered patients eligible for primary analysis was 2.9%. Median intensive care unit and hospital stay were 2 and 9 days, respectively. Grade 3 or higher adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%). At a median follow-up of 35.8 months, the estimated 3-year overall survival was 58.4% (95% confidence interval: 47.7%-67.6%). Locoregional recurrence occurred in only 7 patients (6.7%).
  
  
  CONCLUSIONS
  This prospective multicenter study demonstrated that MIE is feasible and safe with low perioperative morbidity and mortality and good oncological results. This approach can be adopted by other centers with appropriate expertise in open esophagectomy and minimally invasive surgery.
authors.affiliation: *Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, PA †Department of Biostatistics and Computational Biology, Dana Farber Cancer Institute, Harvard School of Public Health, Boston, MA ‡Department of Thoracic Surgery, Brigham and Women's Hospital, Boston, MA §Division of Hematology/Oncology, Department of Medicine, Northwestern University, Chicago, IL ¶Division of Thoracic and Foregut Surgery, Department of Surgery, University of Minnesota, Minneapolis ‖Division of Gastrointestinal Surgery, Department of Surgery, University of California Irvine Medical Center, Orange, CA **Department of Cardiothoracic Surgery, Boston Medical Center, Boston, MA.
authors.forename: James D
authors.initials: JD
authors.lastname: Luketich
authors.forename: Arjun
authors.initials: A
authors.lastname: Pennathur
authors.forename: Yoko
authors.initials: Y
authors.lastname: Franchetti
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Catalano
authors.forename: Scott
authors.initials: S
authors.lastname: Swanson
authors.forename: David J
authors.initials: DJ
authors.lastname: Sugarbaker
authors.forename: Alberto
authors.initials: A
authors.lastname: De Hoyos
authors.forename: Michael A
authors.initials: MA
authors.lastname: Maddaus
authors.forename: Ninh T
authors.initials: NT
authors.lastname: Nguyen
authors.forename: Al B
authors.initials: AB
authors.lastname: Benson
authors.forename: Hiran C
authors.initials: HC
authors.lastname: Fernando
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057868:Anastomotic Leak / Q000453:epidemiology; D015897:Comorbidity; D003422:Critical Care / Q000706:statistics & numerical data; D004938:Esophageal Neoplasms / Q000401:mortality / Q000601:surgery*; D016629:Esophagectomy / Q000379:methods* / Q000401:mortality; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D010535:Laparoscopy / Q000379:methods*; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D061646:Operative Time; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D015996:Survival Rate; D013906:Thoracoscopy / Q000379:methods*; D016896:Treatment Outcome