TY - JOUR
T1 - Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial
T2 - study protocol of the ICAN randomized controlled trial
AU - van Workum, Frans
AU - Bouwense, Stefan A. W.
AU - Luyer, Misha D. P.
AU - Nieuwenhuijzen, Grard A. P.
AU - van der Peet, Donald L.
AU - Daams, Freek
AU - Kouwenhoven, Ewout A.
AU - van det, Marc J.
AU - van den Wildenberg, Frits J. H.
AU - Polat, Fatih
AU - Gisbertz, Suzanne S.
AU - Henegouwen, Mark I. van Berge
AU - Heisterkamp, Joos
AU - Langenhoff, Barbara S.
AU - Martijnse, Ingrid S.
AU - Grutters, Janneke P.
AU - Klarenbeek, Bastiaan R.
AU - Rovers, Maroeska M.
AU - Rosman, Camiel
PY - 2016
Y1 - 2016
N2 - 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
AB - 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
KW - Journal Article
U2 - https://doi.org/10.1186/s13063-016-1636-2
DO - https://doi.org/10.1186/s13063-016-1636-2
M3 - Article
C2 - 27756419
SN - 1745-6215
VL - 17
SP - 505
JO - Trials
JF - Trials
IS - 1
ER -