oesophagectomy, minimally invasive, open, cancer
Conditions
Interventions
Comparison between traditional open and minimally invasive transthoracic resection for oesophageal cancer.
Sponsors
VU university medical center
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Carcinoma of the cervical oesophagus; 2. Prior thoracic surgery; 3. No informed consent is provided.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory complications (infections) within two weeks after the operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Operation related events (e.g. duration of operation, blood-loss); 2. Re-operations; 3. General morbidity (major and minor); 4. Length of ICU and hospital stay (days); 5. Type and number of analgesics needed after operation; 6. VAS-pain-score; 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; 11. Readmissions; 12. Survival. | — |
Contacts
Public ContactS.S.A.Y. Biere
De Boelelaan 1117
Outcome results
None listed