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

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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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          Most cited references21

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          International Consensus on Standardization of Data Collection for Complications Associated With Esophagectomy: Esophagectomy Complications Consensus Group (ECCG).

          Perioperative complications influence long- and short-term outcomes after esophagectomy. The absence of a standardized system for defining and recording complications and quality measures after esophageal resection has meant that there is wide variation in evaluating their impact on these outcomes.
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            Outcomes after minimally invasive esophagectomy: review of over 1000 patients.

            Esophagectomy is a complex operation and is associated with significant morbidity and mortality. In an attempt to lower morbidity, we have adopted a minimally invasive approach to esophagectomy. Our primary objective was to evaluate the outcomes of minimally invasive esophagectomy (MIE) in a large group of patients. Our secondary objective was to compare the modified McKeown minimally invasive approach (videothoracoscopic surgery, laparoscopy, neck anastomosis [MIE-neck]) with our current approach, a modified Ivor Lewis approach (laparoscopy, videothoracoscopic surgery, chest anastomosis [MIE-chest]). We reviewed 1033 consecutive patients undergoing MIE. Elective operation was performed on 1011 patients; 22 patients with nonelective operations were excluded. Patients were stratified by surgical approach and perioperative outcomes analyzed. The primary endpoint studied was 30-day mortality. The MIE-neck was performed in 481 (48%) and MIE-Ivor Lewis in 530 (52%). Patients undergoing MIE-Ivor Lewis were operated in the current era. The median number of lymph nodes resected was 21. The operative mortality was 1.68%. Median length of stay (8 days) and ICU stay (2 days) were similar between the 2 approaches. Mortality rate was 0.9%, and recurrent nerve injury was less frequent in the Ivor Lewis MIE group (P < 0.001). MIE in our center resulted in acceptable lymph node resection, postoperative outcomes, and low mortality using either an MIE-neck or an MIE-chest approach. The MIE Ivor Lewis approach was associated with reduced recurrent laryngeal nerve injury and mortality of 0.9% and is now our preferred approach. Minimally invasive esophagectomy can be performed safely, with good results in an experienced center.
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              Adenocarcinoma of the esophagogastric junction: results of surgical therapy based on anatomical/topographic classification in 1,002 consecutive patients.

              To assess the outcome of surgical therapy based on a topographic/anatomical classification of adenocarcinoma of the esophagogastric junction. Because of its borderline location between the stomach and esophagus, the choice of surgical strategy for patients with adenocarcinoma of the esophagogastric junction is controversial. In a large single-center series of 1,002 consecutive patients with adenocarcinoma of the esophagogastric junction, the choice of surgical approach was based on the location of the tumor center or tumor mass. Treatment of choice was esophagectomy for type I tumors (adenocarcinoma of the distal esophagus) and extended gastrectomy for type II tumors (true carcinoma of the cardia) and type III tumors (subcardial gastric cancer infiltrating the distal esophagus). Demographic data, morphologic and histopathologic tumor characteristics, and long-term survival rates were compared among the three tumor types, focusing on the pattern of lymphatic spread, the outcome of surgery, and prognostic factors in patients with type II tumors. There were marked differences in sex distribution, associated intestinal metaplasia in the esophagus, tumor grading, tumor growth pattern, and stage distribution between the three tumor types. The postoperative death rate was higher after esophagectomy than extended total gastrectomy. On multivariate analysis, a complete tumor resection (R0 resection) and the lymph node status (pN0) were the dominating independent prognostic factors for the entire patient population and in the three tumor types, irrespective of the surgical approach. In patients with type II tumors, the pattern of lymphatic spread was primarily directed toward the paracardial, lesser curvature, and left gastric artery nodes; esophagectomy offered no survival benefit over extended gastrectomy in these patients. The classification of adenocarcinomas of the esophagogastric junction into type I, II, and III tumors shows marked differences between the tumor types and provides a useful tool for selecting the surgical approach. For patients with type II tumors, esophagectomy offers no advantage over extended gastrectomy if a complete tumor resection can be achieved.
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                Author and article information

                Contributors
                0031 24 361 1111 , 31 6 2128 2881 , f_van_workum@hotmail.com
                0031 24 361 1111 , stefan.bouwense@radboudumc.nl
                0031 40 239 9111 , misha.luyer@catharinaziekenhuis.nl
                0031 40 239 9111 , grard.nieuwenhuijzen@catharinaziekenhuis.nl
                0031 20 444 4444 , dl.vanderpeet@vumc.nl
                0031 20 444 4444 , f.daams@vumc.nl
                0031 88 708 7878 , e.kouwenhoven@zgt.nl
                0031 88 708 7878 , m.vdet@zgt.nl
                0031 24 365 7657 , f.v.d.wildenberg@cwz.nl
                0031 24 365 7657 , f.polat@cwz.nl
                0031 20 566 2222 , s.s.gisbertz@amc.uva.nl
                0031 20 566 2222 , m.i.vanbergehenegouwen@amc.uva.nl
                0031 13 539 1313 , j.heisterkamp@etz.nl
                0031 13 539 1313 , blangenhoff@tsz.nl
                0031 13 539 1313 , imartijnse@tsz.nl
                0031 24 361 1111 , Janneke.Grutters@radboudumc.nl
                0031 24 361 1111 , bastiaan.klarenbeek@radboudumc.nl
                0031 24 361 1111 , Maroeska.rovers@radboudumc.nl
                0031 24 361 1111 , camiel.rosman@radboudumc.nl
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                18 October 2016
                18 October 2016
                2016
                : 17
                : 505
                Affiliations
                [1 ]Department of Surgery, Radboudumc, PO Box 9101, 6500 HB Nijmegen, The Netherlands
                [2 ]Department of Surgery, Catharina Hospital, PO Box 1350, 5602 ZA Eindhoven, The Netherlands
                [3 ]Department of Surgery, VU University Medical Centre, PO Box 7057, 1007 MB Amsterdam, The Netherlands
                [4 ]Department of Surgery, Ziekenhuisgroep Twente, PO Box 7600, 7600 SZ Almelo, The Netherlands
                [5 ]Department of Surgery, Canisius-Wilhelmina Hospital, PO Box 9015, 6500 GS Nijmegen, The Netherlands
                [6 ]Department of Surgery, Academic Medical Centre, PO Box 22660, 1100 DD Amsterdam, The Netherlands
                [7 ]Department of Surgery, Elisabeth-Tweesteden Hospital, PO Box 90151, 5000 LC Tilburg, The Netherlands
                [8 ]Department of Health Evidence, Radboudumc, PO Box 9101, 6500 HB Nijmegen, The Netherlands
                Author information
                http://orcid.org/0000-0003-0623-9066
                Article
                1636
                10.1186/s13063-016-1636-2
                5069944
                27756419
                ae1cfa4d-0c5c-42f1-8931-f0d74f269ecf
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 10 June 2016
                : 3 October 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001826, ZonMw;
                Award ID: 843002607
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100006209, Radboud Universitair Medisch Centrum;
                Award ID: -
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Medicine
                minimally invasive esophagectomy,esophageal carcinoma,intrathoracic anastomosis,cervical anastomosis,anastomotic leakage,dysphagia,quality of life

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