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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

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

Published in: Trials | Issue 1/2016

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Abstract

Background

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.

Methods/design

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.

Discussion

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.

Trial registration

Netherlands Trial Register: NTR4333. Registered on 23 December 2013.
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Metadata
Title
Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial
Authors
Frans van Workum
Stefan A. W. Bouwense
Misha D. P. Luyer
Grard A. P. Nieuwenhuijzen
Donald L. van der Peet
Freek Daams
Ewout A. Kouwenhoven
Marc J van Det
Frits J. H. van den Wildenberg
Fatih Polat
Suzanne S. Gisbertz
Mark I. van Berge Henegouwen
Joos Heisterkamp
Barbara S. Langenhoff
Ingrid S. Martijnse
Janneke P. Grutters
Bastiaan R. Klarenbeek
Maroeska M. Rovers
Camiel Rosman
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1636-2

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