Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
This study aim to observe and compare the change of alarmins such as high mobility group nucleosome-binding protein-1 (HMGN1), high mobility group proteins b1 (HMGb1), Interleukin (IL)-33 and their soluble receptors including soluble toll like receptor 4 (sTLR4) and soluble ST2 (sST2) during pulmonary lobectomy for cancer patients receiving volatile anesthesia or intravenous anesthesia under one-lung ventilation (OLV). By which, this study will preliminarily evaluate the correlation of alarmins and prognosis as well as the effect of inhalational and intravenous anesthesia on the prognosis of surgical patients.
Detailed description
During pulmonary lobectomy, as a result of OLV and surgical operation, patients can suffer from alveolar and systemic inflammatory response. Alarmin is endogenous peptide released by white blood cells and epithelial cells when the body undergo danger signal stimulation which can enhance immune response and has a double effect on tumor. Some alarmins and their soluble receptors such as HMGN1, HMGb1, IL-33 and their soluble receptors including sTLR4 and sST2 can be used as biomarkers for tumor progression. Previous studies have shown that sevoflurane anesthesia can reduce the level of inflammatory cytokines in bronchoalveolar lavage fluid. Meanwhile, the latest retrospective study indicated that the mortality of cancer patients receiving volatile anesthesia was significantly higher than that of intravenous anesthesia. At this stage, no study aimed to investigate the change of alarmins in broncho-alveoli and serum during OLV lung surgery and the possible effect of different anesthetics on them. Therefore, the investigators plan to enroll 40 patients with lung cancer receiving pulmonary lobectomy. Patients are randomly divided into sevoflurane volatile anesthesia group and propofol intravenous anesthesia group (n=20). Perioperative serum and bronchoalveolar lavage from ventilated lung are obtained, using ELISA method, to assay and compare the changes of alarmins such as HMGN1, HMGb1, IL-33 and their soluble receptors including sTLR4 and sST2 between two groups. All the patients will be followed up for 12 months. The correlation of alarmins and prognosis as well as the effect of volatile and intravenous anesthesia on the prognosis of patients will be preliminarily evaluated.
Interventions
DRUGSevoflurane
DRUGPropofol
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* American society of Anesthesiology (ASA) status I-II * pathological diagnosis of lung cancer before surgery * receive pulmonary lobectomy * with normal lung function * without heart failure (NYHA\>2), obstructive or restrictive lung disease * no history of other malignancy tumor * body mass index (Body mass, index, BMI) \< 35kg/m2 * no severe coagulopathy * no severe systemic or pulmonary infection * did not participate in other clinical trials
Exclusion criteria
* persistent smoking history * immunosuppressive drug use 6 weeks before operation * receive total pneumonectomy * failure to complete treatment or follow-up * severe adverse drug reactions * severe postoperative complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of level of HMGb1 | 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery |
| Change of level of IL-33 | 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery |
| Change of level of sST2 | 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery |
| Change of level of HMGN1 | 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery |
| Change of level of sTLR4 | 10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 12 months | Overall survival means the amount of time that patient lives to the end of observation or death. |
| Disease-free survival | 12 months | disease-free survival means the amount of time that patient lives without known recurrence after surgery to the end of observation or recurrence. |
Contacts
Primary ContactKaiyuan Wang, PhD
Outcome results
None listed