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Open Access Highly Accessed Study protocol

Traditional invasive vs. minimally invasive esophagectomy: a multi-center, randomized trial (TIME-trial)

Surya SAY Biere1, Kirsten W Maas1, Luigi Bonavina3, Josep Roig Garcia4, Mark I van Berge Henegouwen5, Camiel Rosman6, Meindert N Sosef7, Elly SM de Lange2, H Jaap Bonjer1, Miguel A Cuesta1* and Donald L van der Peet1*

Author Affiliations

1 Department of Surgery, VU university medical center, Amsterdam, the Netherlands

2 Department of Clinical Epidemiology and Biostatistics, VU university medical center, Amsterdam, the Netherlands

3 Department of Surgery, I.R.C.C.S. Policlinico San Donato, University of Milan, Milan, Italy

4 Department of Surgery, Hospital Universitari de Girona Dr Josep Trueta, Girona, Spain

5 Department of Surgery, Academic Medical Center, Amsterdam, the Netherlands

6 Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands

7 Department of Surgery, Atrium Medical Center, Heerlen, the Netherlands

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BMC Surgery 2011, 11:2  doi:10.1186/1471-2482-11-2

Published: 12 January 2011

Abstract

Background

There 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/Design

Comparison 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.

Discussion

The 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