Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial.

Frans Van Workum,Bastiaan R Klarenbeek,Fatih Polat,Ingrid S Martijnse,Ewout A Kouwenhoven,Joos Heisterkamp,Grard A P Nieuwenhuijzen,Camiel Rosman,Frits J H Van Den Wildenberg,Donald L Van Der Peet,Maroeska M Rovers,Freek Daams,Misha D P Luyer,Janneke P Grutters,Barbara S Langenhoff,Stefan A W Bouwense,Suzanne S Gisbertz,Marc J Van Det,Mark I Van Berge Henegouwen

doi:10.1186/s13063-016-1636-2

Abstract

BackgroundCurrently, 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.Methods/designThe 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.DiscussionWe 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.Trial registrationNetherlands Trial Register: NTR4333. Registered on 23 December 2013.

Highlights

A cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE)
We hypothesize that an intrathoracic esophagogastric anastomosis (IEA) after MIE is associated with a lower incidence of anastomotic leakage requiring reintervention or reoperation than a CEA
Study aim The aim 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

Summary

Discussion

The use of MIE is increasing worldwide, because it has been shown to reduce postoperative morbidity [15, 16]. There is currently no high-quality evidence available that favours IEA over CEA after MIE in terms of anastomotic leakage, other postoperative morbidity, functional results, quality of life or costs. Without evidence for a benefit of IEA over CEA and in the presence of learning curve associated morbidity, the use of an intrathoracic anastomosis as the standard reconstruction after MIE is questioned. In theory, both anastomotic locations have possible benefits. The ICAN trial will provide important data on anastomotic leakage, other postoperative morbidity, mortality, quality of life, functional results and cost-effectiveness up to 2 years after MIE. Author details 1Department of Surgery, Radboudumc, PO Box 9101, 6500 HB Nijmegen, The Netherlands. 2Department of Surgery, Catharina Hospital, PO Box 1350, 5602 ZA Eindhoven, The Netherlands. 3Department of Surgery, VU University Medical Centre, PO Box 7057, 1007 MB Amsterdam, The Netherlands. 4Department of Surgery, Ziekenhuisgroep Twente, PO Box 7600, 7600 SZ Almelo, The Netherlands. 5Department of Surgery, Canisius-Wilhelmina Hospital, PO Box 9015, 6500 GS Nijmegen, The Netherlands. 6Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD Amsterdam, The Netherlands. 7Department of Surgery, Elisabeth-Tweesteden Hospital, PO Box 90151, 5000 LC Tilburg, The Netherlands. 8Department of Health Evidence, Radboudumc, PO Box 9101, 6500 HB Nijmegen, The Netherlands

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