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

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.

Intrathoracic versus cervical anastomosis and predictors of anastomotic leakage after oesophagectomy for cancer

“…In addition, centre‐ and surgeon‐specific data on leak rates were not available for the purpose of this study, although these data are available for the individual centres. At present, a randomized trial comparing the intrathoracic and cervical approach is under way that should resolve these limitations and make an important contribution to the current literature.…”

“…In addition, centre-and surgeon-specific data on leak rates were not available for the purpose of this study, although these data are available for the individual centres. At present, a randomized trial 41 comparing the intrathoracic and cervical approach is under way that should resolve these limitations and make an important contribution to the current literature. nature of the data collected for this study, requests to access the data set from qualified researchers trained in human subject confidentiality protocols may be sent to the DUCA at onderzoek@dica.nl.…”

McKeown or Ivor Lewis totally minimally invasive esophagectomy for cancer of the esophagus and gastroesophageal junction: systematic review and meta-analysis

“…To answer this question, the ICAN randomized controlled trial is currently being conducted in the Netherlands and this trial randomizes 200 patients between TMIE McKeown and TMIE Ivor Lewis. In addition to postoperative morbidity and the severity of complications, this trial is also powered for finding differences in quality of life, functional results and cost-effectiveness (28).…”

Diagnosis, assessment, and management of surgical complications following esophagectomy

“…According to the current literature, cervical leakage is significantly higher than intrathoracic anastomotic insufficiency (32% versus 15%) . Possible contributing factors include the longer distance of the gastric interponat needed for cervical anastomosis, greater anastomotic tension, worse microcirculation at the tip of the esophageal substitute, and higher risk of compression at the thoracic inlet.…”

“…According to the current literature, cervical leakage is significantly higher than intrathoracic anastomotic insufficiency (32% versus 15%). 24,[63][64][65][66] Possible contributing factors include the longer distance of the gastric interponat needed for cervical anastomosis, greater anastomotic tension, worse microcirculation at the tip of the esophageal substitute, and higher risk of compression at the thoracic inlet. However, cervical leaks are associated with fewer life-threatening complications, especially those with infectious presentations, such as mediastinitis, sepsis, erosion, bleeding, and aerodigestive fistulae, as compared with intrathoracic leaks.…”