Traditional invasive versus minimally invasive esophagectomy.

Background:

There is a rise in incidence of oesophageal 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 oesophageal 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 oesophagectomy could reduce the morbidity and accelerate the postoperative recovery.



Methods/Design:

Comparison between traditional open and minimally invasive oesphagectomy in a multi-centered, randomized trial. Patients with a resectable intrathoracic oesophageal carcinoma, including the gastro-oesophageal junction tumors (Siewert I) are eligible for inclusion. Prior thoracic surgery and cervical oesophageal 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 postoperative respiratory complications within the first two postoperative weeks confirmed by clinical, radiological and sputum culture data. Secondary endpoints are the operative data, the postoperative 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. Postoperative 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 oesophageal resection in patients with resectable intrathoracic and junction oesophageal cancer.

Patients undergoing a minimally invasive oesophagectomy have fewer morbidity, a shorter duration of the intensive care unit (ICU) admission and a better quality of life than following the traditional approach.

1. Before neo-adjuvant therapy;

2. After neo-adjuvant therapy (before surgery);

3. Post-operative in hospital period;

4. 6 weeks after surgery;

5. 3 months after surgery;

6. 6 months after surgery;

7. 1 year after surgery.

Comparison between traditional open and minimally invasive transthoracic resection for oesophageal cancer.