oesophaguscarcinoom
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients selected for a curative intended esophagectomy. Patients >18 years with a given informed consent Histological proven esophageal or GEJ cancer (adeno/squamous cell) ASA class 2 or less (only for HFJV study)
Exclusion criteria
Exclusion criteria: Patients who are mentally disabled or incapable to give informed consent Patients with severe (bullous) emphysema (only for HFJV study) ASA class 3 or more (only for HFJV study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint for prospective cohort study and pilot RCT Prospective cohort study: Immunological response (TNF-a, CRP, FABP, procalcitonine, IL-1, IL-2, IL-6, IL-8, IL-10 and chemokine receptors (CXCR1/CXCR2)) as predictor for the following parameters/endpoints: 1. Complications: Pulmonary complications; respiratory insufficiency, acute respiratory distress syndrome (ARDS), pneumonia, atelectasis, pleural effusion, empyema and pulmonary embolism. Cardiac complications; arrhythmia and myocardial infarction. Other major complications; subphrenic abscess and/or intra-abdominal abscess, systemic inflammatory response syndrome (SIRS), sepsis, anastomotic leakage, chylothorax, renal failure, liver failure and ileus. 2. Short-term outcome: postoperative mortality, hereby defined as death within 90 days after esophagectomy or any death during admission in hospital where the resection was performed. 3. Long-term outcome: patients without postoperative mortality will be selected and only cancer related death cause will be scored. Death of any other cause will be scored as end of follow up 4. The estimates will be adjusted for the following patients* and tumour characteristics: age, use of neo-adjuvant therapy, comorbidity, ASA-classification, POSSUM score and TNM classification. Pilot RCT: Differences in immunological response between HFJV and conventional ventilation, analyzed by using following concentrations: TNF-a, CRP, FABP, procalcitonine, IL-1, IL-2, IL-6, IL-8, IL-10 and chemokine receptors (CXCR1/CXCR2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Prospective cohort study To explore the value of polymorphism at TNF-a gene locus (TNF-a genotype 308) as a useful predictor of preoperative risk assessment for mortality and morbidity after esophagectomy. Pilot RCT 1. Differences in complications between HFJV and conventional ventilation: Pulmonary complications; respiratory insufficiency, ARDS, pneumonia, atelectasis, pleural effusion, empyema and pulmonary embolism. Cardiac complications; arrhythmia and myocardial infarction. Other major complications; SIRS, sepsis, anastomotic leakage. 2. To investigate differences in frequencies of death within 90 days after esophagectomy or any death during admission in hospital where the resection was performed between HFJV and conventional ventilation. 3. To investigate whether there are differences between both breathing techniques (conventional vs HFJV) in the conduct of the operation (blood loss, operation time) and recorded intraoperative anesthesiologic variables: BIS (bispectral edge), cardiac output measurements (using PICCO (Puls Contour Cardiac Output)), transcutaneous CO2 (TcCO2) measurement, ROS, EVLW (extra-vascular lung water) and ITBV (intrathoracic blood volume). | — |
Countries
Netherlands
Outcome results
None listed