T raditional i nvasive vs. m inimally invasive e sophagectomy: a multi-center, randomized trial (TIME-trial)

BMC Surgery

Study Protocol

Elly SM de Lange¹  Mark I van Berge Henegouwen²  Meindert N Sosef³  Camiel Rosman⁴  Josep Roig Garcia⁵  Luigi Bonavina⁶  Kirsten W Maas⁷  Miguel A Cuesta⁷  Surya SAY Biere⁷  Donald L van der Peet⁷  H Jaap Bonjer⁷ 

[1] Department of Clinical Epidemiology and Biostatistics, VU university medical center, Amsterdam, The Netherlands;Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands;Department of Surgery, Atrium Medical Center, Heerlen, The Netherlands;Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands;Department of Surgery, Hospital Universitari de Girona Dr Josep Trueta, Girona, Spain;Department of Surgery, I.R.C.C.S. Policlinico San Donato, University of Milan, Milan, Italy;Department of Surgery, VU university medical center, Amsterdam, The Netherlands;

关键词: Esophageal Cancer;    Esophageal Resection;    Gastric Conduit;    Posterolateral Thoracotomy;    Invasive Esophagectomy;   

DOI  :  10.1186/1471-2482-11-2

 received in 2010-09-01, accepted in 2011-01-12,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundThere is a rise in incidence of esophageal carcinoma due to increasing incidence of adenocarcinoma. Probably the only curative option to date is the use of neoadjuvant therapy followed by surgical resection. Traditional open esophageal resection is associated with a high morbidity and mortality rate. Furthermore, this approach involves long intensive care unit stay, in-hospital stay and long recovery period. Minimally invasive esophagectomy could reduce the morbidity and accelerate the post-operative recovery.Methods/DesignComparison between traditional open and minimally invasive esophagectomy in a multi-center, randomized trial. Patients with a resectable intrathoracic esophageal carcinoma, including the gastro-esophageal junction tumors (Siewert I) are eligible for inclusion. Prior thoracic surgery and cervical esophageal carcinoma are indications for exclusion. The surgical technique involves a right thoracotomy with lung blockade and laparotomy either with a cervical or thoracic anastomosis for the traditional group. The minimally invasive procedure involves a right thoracoscopy in prone position with a single lumen tube and laparoscopy either with a cervical or thoracic anastomosis. All patients in both groups will undergo identical pre-operative and post-operative protocol. Primary endpoint of this study are post-operative respiratory complications within the first two post-operative weeks confirmed by clinical, radiological and sputum culture data. Secondary endpoints are the operative data, the post-operative data and oncological data such as quality of the specimen and survival. Operative data include duration of the operation, blood loss and conversion to open procedure. Post-operative data include morbidity (major and minor), quality of life tests and hospital stay.Based on current literature and the experience of all participating centers, an incidence of pulmonary complications for 57% in the traditional arm and 29% in the minimally invasive arm, it is estimated that per arm 48 patients are needed. This is based on a two-sided significance level (alpha) of 0.05 and a power of 0.80. Knowing that approximately 20% of the patients will be excluded, we will randomize 60 patients per arm.DiscussionThe TIME-trial is a prospective, multi-center, randomized study to define the role of minimally invasive esophageal resection in patients with resectable intrathoracic and junction esophageal cancer.Trial registration (Netherlands Trial Register)NTR2452

【 授权许可】

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© Biere et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.