title: Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial.
abstract: Currently, a cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE). However, the CEA is associated with a considerable incidence of anastomotic leakage requiring reintervention or reoperation and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) might reduce the incidence of anastomotic leakage, improve functional results and reduce costs. The objective of the ICAN trial is to compare anastomotic leakage and postoperative morbidity, mortality, quality of life and cost-effectiveness between CEA and IEA after MIE.
  
  
  
  The ICAN trial is an open randomized controlled multicentre superiority trial, comparing CEA (control group) with IEA (intervention group) after MIE. All patients with esophageal cancer planning to undergo curative MIE are considered for inclusion. A total of 200 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is anastomotic leakage requiring reintervention or reoperation, and secondary outcomes are (amongst others) other postoperative complications, new onset of organ failure, length of stay, mortality, benign strictures requiring dilatation, quality of life and cost-effectiveness.
  
  
  
  We hypothesize that an IEA after MIE is associated with a lower incidence of anastomotic leakage requiring reintervention or reoperation than a CEA. The trial is also designed to give answers to additional research questions regarding a possible difference in functional outcome, quality of life and cost-effectiveness.
  
  
  
  Netherlands Trial Register: NTR4333 . Registered on 23 December 2013.
authors.affiliation: Department of Surgery, Radboudumc, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. f_van_workum@hotmail.com.
authors.forename: Frans
authors.identifier: 0000-0003-0623-9066
authors.initials: F
authors.lastname: van Workum
authors.affiliation: Department of Surgery, Radboudumc, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Stefan A W
authors.initials: SA
authors.lastname: Bouwense
authors.affiliation: Department of Surgery, Catharina Hospital, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
authors.forename: Misha D P
authors.initials: MD
authors.lastname: Luyer
authors.affiliation: Department of Surgery, Catharina Hospital, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands.
authors.forename: Grard A P
authors.initials: GA
authors.lastname: Nieuwenhuijzen
authors.affiliation: Department of Surgery, VU University Medical Centre, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.
authors.forename: Donald L
authors.initials: DL
authors.lastname: van der Peet
authors.affiliation: Department of Surgery, VU University Medical Centre, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.
authors.forename: Freek
authors.initials: F
authors.lastname: Daams
authors.affiliation: Department of Surgery, Ziekenhuisgroep Twente, PO Box 7600, 7600 SZ, Almelo, The Netherlands.
authors.forename: Ewout A
authors.initials: EA
authors.lastname: Kouwenhoven
authors.affiliation: Department of Surgery, Ziekenhuisgroep Twente, PO Box 7600, 7600 SZ, Almelo, The Netherlands.
authors.forename: Marc J
authors.initials: MJ
authors.lastname: van Det
authors.affiliation: Department of Surgery, Canisius-Wilhelmina Hospital, PO Box 9015, 6500 GS, Nijmegen, The Netherlands.
authors.forename: Frits J H
authors.initials: FJ
authors.lastname: van den Wildenberg
authors.affiliation: Department of Surgery, Canisius-Wilhelmina Hospital, PO Box 9015, 6500 GS, Nijmegen, The Netherlands.
authors.forename: Fatih
authors.initials: F
authors.lastname: Polat
authors.affiliation: Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
authors.forename: Suzanne S
authors.initials: SS
authors.lastname: Gisbertz
authors.affiliation: Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.
authors.forename: Mark I van Berge
authors.initials: MI
authors.lastname: Henegouwen
authors.affiliation: Department of Surgery, Elisabeth-Tweesteden Hospital, PO Box 90151, 5000 LC, Tilburg, The Netherlands.
authors.forename: Joos
authors.initials: J
authors.lastname: Heisterkamp
authors.affiliation: Department of Surgery, Elisabeth-Tweesteden Hospital, PO Box 90151, 5000 LC, Tilburg, The Netherlands.
authors.forename: Barbara S
authors.initials: BS
authors.lastname: Langenhoff
authors.affiliation: Department of Surgery, Elisabeth-Tweesteden Hospital, PO Box 90151, 5000 LC, Tilburg, The Netherlands.
authors.forename: Ingrid S
authors.initials: IS
authors.lastname: Martijnse
authors.affiliation: Department of Health Evidence, Radboudumc, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Janneke P
authors.initials: JP
authors.lastname: Grutters
authors.affiliation: Department of Surgery, Radboudumc, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Bastiaan R
authors.initials: BR
authors.lastname: Klarenbeek
authors.affiliation: Department of Health Evidence, Radboudumc, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Maroeska M
authors.initials: MM
authors.lastname: Rovers
authors.affiliation: Department of Surgery, Radboudumc, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Camiel
authors.initials: C
authors.lastname: Rosman
mesh_terms: D000714:Anastomosis, Surgical / Q000009:adverse effects / Q000379:methods*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003625:Data Collection; D004938:Esophageal Neoplasms / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D019060:Minimally Invasive Surgical Procedures / Q000379:methods*; D011788:Quality of Life
keywords: Anastomotic leakage; Cervical anastomosis; Dysphagia; Esophageal carcinoma; Intrathoracic anastomosis; Minimally invasive esophagectomy; Quality of life