title: Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial).
abstract: BACKGROUND
  For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer.
  
  
  METHODS
  This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥ 18 and ≤ 80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56) or open three-stage transthoracic esophageal resection (n = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications.
  
  
  CONCLUSIONS
  This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient.
  
  
  BACKGROUND
  Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790.
authors.affiliation: Department of Surgery, G04,228, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, CX, 3584, the Netherlands. p.c.vandersluis-2@umcutrecht.nl
authors.forename: Pieter C
authors.initials: PC
authors.lastname: van der Sluis
authors.forename: Jelle P
authors.initials: JP
authors.lastname: Ruurda
authors.forename: Sylvia
authors.initials: S
authors.lastname: van der Horst
authors.forename: Roy J J
authors.initials: RJ
authors.lastname: Verhage
authors.forename: Marc G H
authors.initials: MG
authors.lastname: Besselink
authors.forename: Margriet J D
authors.initials: MJ
authors.lastname: Prins
authors.forename: Leonie
authors.initials: L
authors.lastname: Haverkamp
authors.forename: Carlo
authors.initials: C
authors.lastname: Schippers
authors.forename: Inne H M Borel
authors.initials: IH
authors.lastname: Rinkes
authors.forename: Hans C A
authors.initials: HC
authors.lastname: Joore
authors.forename: Fiebo Jw
authors.initials: FJ
authors.lastname: Ten Kate
authors.forename: Hendrik
authors.initials: H
authors.lastname: Koffijberg
authors.forename: Christiaan C
authors.initials: CC
authors.lastname: Kroese
authors.forename: Maarten S
authors.initials: MS
authors.lastname: van Leeuwen
authors.forename: Martijn P J K
authors.initials: MP
authors.lastname: Lolkema
authors.forename: Onne
authors.initials: O
authors.lastname: Reerink
authors.forename: Marguerite E I
authors.initials: ME
authors.lastname: Schipper
authors.forename: Elles
authors.initials: E
authors.lastname: Steenhagen
authors.forename: Frank P
authors.initials: FP
authors.lastname: Vleggaar
authors.forename: Emile E
authors.initials: EE
authors.lastname: Voest
authors.forename: Peter D
authors.initials: PD
authors.lastname: Siersema
authors.forename: Richard
authors.initials: R
authors.lastname: van Hillegersberg
mesh_terms: D000230:Adenocarcinoma / Q000191:economics / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000191:economics / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004938:Esophageal Neoplasms / Q000191:economics / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects / Q000191:economics / Q000379:methods* / Q000401:mortality; D017721:Hospital Costs; D017052:Hospital Mortality; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D007902:Length of Stay; D008197:Lymph Node Excision; D008875:Middle Aged; D009367:Neoplasm Staging; D009426:Netherlands; D011183:Postoperative Complications / Q000401:mortality; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D012371:Robotics; D025321:Surgery, Computer-Assisted / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D013906:Thoracoscopy / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult