|- candidate number||8300|
|- NTR Number||NTR2452|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-aug-2010|
|- Secondary IDs||HGE2008/003 METC VUmc|
|- Public Title||Traditional invasive versus minimally invasive esophagectomy.|
|- Scientific Title||Traditional invasive vs. minimally invasive esophagectomy: a multi-centered, randomized trial.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Cancer, Minimally invasive surgical procedures, Open surgery, Oesophagectomy|
|- Inclusion criteria||1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic oesophagus and Siewert I junction tumors which are surgically resectable (T1-3, N0-1, M0);|
2. Treatment with neo-adjuvant therapy;
3. Age of the patients must be ≥ 18 and ≤ 75 years;
4. European Clinical Oncology Group (ECOG) performance status of 0, 1 or 2;
5. Written informed consent.
|- Exclusion criteria||1. Carcinoma of the cervical oesophagus;|
2. Prior thoracic surgery;
3. No informed consent is provided.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2009|
|- planned closingdate||1-apr-2011|
|- Target number of participants||160|
|- Interventions||Comparison between traditional open and minimally invasive transthoracic resection for oesophageal cancer.|
|- Primary outcome||Respiratory complications (infections) within two weeks after the operation.|
|- Secondary outcome||1. Operation related events (e.g. duration of operation, blood-loss);|
3. General morbidity (major and minor);
4. Length of ICU and hospital stay (days);
5. Type and number of analgesics needed after operation;
7. Return to fluid and normal diet;
8. Quality of life questionnaires (SF-36 and EORTC QLQ-OES18);
9. Quality of the specimen resected (e.g. length of specimen, number and location of lymph nodes resected and circumferential resection margin);
10. Hospital mortality;
|- Timepoints||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.
|- Trial web site||www.time-trial.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| S.S.A.Y. Biere|
|- CONTACT for SCIENTIFIC QUERIES|| D.L. Peet, van der|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Publications||Biere SSAY, Cuesta MA, van der Peet DL. Minimally invasive versus open esophagectomy for cancer: a systematic review and meta-analysis. Minerva Chirurgica. 2009; 64: 121-133.|
|- Brief summary||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.
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.
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.
|- Main changes (audit trail)|
|- RECORD||2-aug-2010 - 15-sep-2011|