Effect of Different Anesthetics on the Change of Alarmins in Lung Cancer Patients Receiving Pulmonary Lobectomy

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Comparison of Volatile and IV Anesthesia on the Change of Alarmins in Lung Cancer Patients Receiving Pulmonary Lobectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02916147
• Other study ID #: E2016066
• Status: Not yet recruiting
• Phase: N/A
• First received: September 21, 2016
• Last updated: September 26, 2016
• Start date: October 2016
• Est. completion date: January 2019

Study information

• Verified date: September 2016
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Kaiyuan Wang, PhD
• Phone: 00862223340123
• Email: 93445729[@]qq.com
• Is FDA regulated: No
• Health authority: China: Tianjin Municipal Health Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Sevoflurane

• Propofol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of level of HMGN1		10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery	No
Primary	Change of level of HMGb1		10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery	No
Primary	Change of level of sTLR4		10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery	No
Primary	Change of level of IL-33		10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery	No
Primary	Change of level of sST2		10 min before OLV, 10 min after OLV, 1 day and 2 day after surgery	No
Secondary	Disease-free survival	disease-free survival means the amount of time that patient lives without known recurrence after surgery to the end of observation or recurrence.	12 months	No
Secondary	Overall survival	Overall survival means the amount of time that patient lives to the end of observation or death.	12 months	No