title: Minimally Invasive Versus Open Esophageal Resection: Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial.
abstract: The aim of this study was to investigate 3-year survival following a randomized controlled trial comparing minimally invasive with open esophagectomy in patients with esophageal cancer.
  
  
  
  Research on minimally invasive esophagectomy (MIE) has shown faster postoperative recovery and a marked decrease in pulmonary complications. Debate is ongoing as to whether the procedure is equivalent to open resection regarding oncologic outcomes. The study is a follow-up study of the TIME-trial (traditional invasive vs minimally invasive esophagectomy, a multicenter, randomized trial).
  
  
  
  Between June 2009 and March 2011, patients with a resectable intrathoracic esophageal carcinoma, including the gastroesophageal junction tumors (Siewert I), were randomized between open and MI esophagectomy with curative intent. Primary outcome was 3-year disease-free survival. Secondary outcomes include overall survival, lymph node yield, short-term morbidity, mortality, complications, radicality, local recurrence, and metastasis. Analysis was by intention-to-treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. Both trial protocol and short-term results have been published previously.
  
  
  
  One hundred fifteen patients were included from 5 European hospitals and randomly assigned to open (n = 56) or MI esophagectomy (n = 59). Combined overall 3-year survival was 40.4% (SD 7.7%) in the open group versus 50.5% (SD 8%) in the minimally invasive group (P = 0.207). The hazard ratio (HR) is 0.883 (0.540 to 1.441) for MIE compared with open surgery. Disease-free 3-year survival was 35.9% (SD 6.8%) in the open versus 40.2% (SD 6.9%) in the MI group [HR 0.691 (0.389 to 1.239).
  
  
  
  The study presented here depicted no differences in disease-free and overall 3-year survival for open and MI esophagectomy. These results, together with short-term results, further support the use of minimally invasive surgical techniques in the treatment of esophageal cancer.
authors.affiliation: *Department of Gastrointestinal Surgery, VU University Medical Center, Amsterdam, the Netherlands †Department of Surgery, Hospital Universitari de Girona Dr Josep Trueta, Girona, Spain ‡Department of Surgery, I.R.C.C.S. Policlinico San Donato University of Milan, Milan, Italy §Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands ¶Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Straatman
authors.forename: Nicole
authors.initials: N
authors.lastname: van der Wielen
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Cuesta
authors.forename: Freek
authors.initials: F
authors.lastname: Daams
authors.forename: Josep
authors.initials: J
authors.lastname: Roig Garcia
authors.forename: Luigi
authors.initials: L
authors.lastname: Bonavina
authors.forename: Camiel
authors.initials: C
authors.lastname: Rosman
authors.forename: Mark I
authors.initials: MI
authors.lastname: van Berge Henegouwen
authors.forename: Suzanne S
authors.initials: SS
authors.lastname: Gisbertz
authors.forename: Donald L
authors.initials: DL
authors.lastname: van der Peet
mesh_terms: D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000401:mortality / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D000071066:Patient Reported Outcome Measures; D011183:Postoperative Complications; D011788:Quality of Life