Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923412
Status:
UNKNOWN
Last Update Posted:
2022-10-26
First Post:
2021-05-23
Brief Title:
Vagus Nerve Preservation and Chronic Cough in Non-small Cell Lung Cancer Surgery
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
Prospective Randomized Controlled Study on the Effects of Vagus Nerve Pulmonary Branch Preservation During Video-assisted Thoracic Surgery Lobectomy in Non-small Cell Lung Cancer Can it Decrease Postoperative Cough and Pulmonary Complications
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lung cancer is the leading cause of cancer death worldwide Surgical resection is the main treatment for resectable non-small-cell lung cancer NSCLC and lobectomy with systemic mediastinal lymph node dissection is the standard surgical method However a significant number of patients experience postoperative chronic cough it is observed in about 60 of patients during the first year of outpatient clinic follow-up and persistently lasts in about 247-50 during the 5 year follow-up period
Several studies showed the association between vagus nerve and chronic cough The bronchopulmonary vagal afferent C-fibers are responsible for cough chest tightness and reflex bronchoconstrictions It is expected that during the mediastinal lymph node dissection the inevitable injuries to the pulmonary branch of vagus nerve is largely responsible for development of chronic cough In other words preservation of pulmonary branch of vagus nerve may reduce the incidence of chronic cough and relevant detrimental effects on quality of life
Therefore this prospective randomized and controlled clinical study aims to evaluate the effect of vagus nerve preservation on postoperative chronic cough in patients undergoing lobectomy with mediastinal lymph node dissection In addition the feasibility and oncologic safety of preserving pulmonary branch of vagus nerve during mediastinal lymph node dissection with minimally invasive surgery compared with conventional mediastinal lymph node dissection with minimally invasive surgery will also be investigated
This trial will provide a new basis for oncologically feasible safe and effective new surgical technique for mediastinal lymph node dissection in patients with early lung cancer undergoing minimally invasive surgery Furthermore the preventive effect of vagus nerve preservation on incidence of chronic cough will be objectively be proven and thus help to broaden the current knowledge of the role of vagus nerve and postoperative chronic cough
Several studies showed the association between vagus nerve and chronic cough The bronchopulmonary vagal afferent C-fibers are responsible for cough chest tightness and reflex bronchoconstrictions It is expected that during the mediastinal lymph node dissection the inevitable injuries to the pulmonary branch of vagus nerve is largely responsible for development of chronic cough In other words preservation of pulmonary branch of vagus nerve may reduce the incidence of chronic cough and relevant detrimental effects on quality of life
Therefore this prospective randomized and controlled clinical study aims to evaluate the effect of vagus nerve preservation on postoperative chronic cough in patients undergoing lobectomy with mediastinal lymph node dissection In addition the feasibility and oncologic safety of preserving pulmonary branch of vagus nerve during mediastinal lymph node dissection with minimally invasive surgery compared with conventional mediastinal lymph node dissection with minimally invasive surgery will also be investigated
This trial will provide a new basis for oncologically feasible safe and effective new surgical technique for mediastinal lymph node dissection in patients with early lung cancer undergoing minimally invasive surgery Furthermore the preventive effect of vagus nerve preservation on incidence of chronic cough will be objectively be proven and thus help to broaden the current knowledge of the role of vagus nerve and postoperative chronic cough
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None