Lung Cancer Clinical Trial
Official title:
The Effect of Adding Intraoperative Regional Anesthesia on Cancer Recurrence in Patients Undergoing Lung Cancer Resection
Verified date | September 2016 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to general anesthesia alone.
Status | Terminated |
Enrollment | 67 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Primary non-small cell lung cancer (stage 1-3) as determined according to the IASLC Lung Cancer Staging Project; - Scheduled for potentially curative tumor resection; - Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia plus general anesthesia or to general anesthesia and postoperative opioid analgesia. Exclusion Criteria: - Any contraindication to epidural anesthesia, (including coagulopathy, abnormal anatomy). - Any contraindication to midazolam, propofol, sevoflurane, fentanyl, morphine, or hydromorphone. - Age < 18 or > 85 years old. - Other cancer not believed by the attending surgeon to be in long-term remission. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
China | Shanghai Chest Hospital | Shanghai | |
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States, China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease-free survival | The effect of regional versus general anesthesia on the primary outcome of disease-free survival (time to the earlier or recurrence or death from any cause) | up to 5 years after surgery | No |
Secondary | NK cell function | Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain. | up to three years post procedure | No |
Secondary | Immune function markers | Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain. | for up to 3 years post procedure | No |
Secondary | Pain | Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain. | up to 3 years post proceudure | No |
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