Lung CancerNCT04923412

Vagus Nerve Preservation and Chronic Cough in Non-small Cell Lung Cancer Surgery

A study testing Pulmonary branch of vagus nerve preserved and Pulmonary branch of vagus nerve not preserved in people with Lung Cancer and Vagus Nerve Injuries, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Lung Cancer, Vagus Nerve Injuries, Cough
What is being tested?: Pulmonary branch of vagus nerve preserved and Pulmonary branch of vagus nerve not preserved
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 214 participants
Where: 1 siteSouth Korea
Study dates: 1 Jul 2021to 30 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study, and can sign the informed consent.
Clinically suspicious of non-small cell lung cancer or tissue confirmed preoperatively
Clinical stage T1-3/N0-1/M0
Preoperative ECOG performance status 0-1
Preoperative ASA class I-III
Preoperative pulmonary function test FEV1 ≥ 60%, DLCO ≥ 60%
Patients expected to achieve R0 (complete resection) via simple lobectomy and mediastinal lymph node dissection

Who cannot join

Patients who smoked within 2 weeks prior to operation
Patients who received antitussives and expectorants 2 weeks prior to operation
Patients who are pregnant or breast feeding
Patients with severe or uncontrolled psychological disorders
Patients with severe pulmonary adhesion
Patients who are ineligible for minimally invasive surgery; thoracotomy conversion

Show all 11Show fewer

Patients diagnosed with other malignancies within 2 years prior to operation
Patients who received chemotherapy or radiotherapy within 6 months prior to operation
Patients suspicious of clinical N2 or received neoadjuvant therapy prior to operation
Patients with cough-related diseases; COPD, asthma, ILD, GERD
Patients suspicious of lymph node metastasis/invasion around vagus nerve during the preoperative clinical staging evaluation

Trial locations and contacts

1 site in 1 country.

Kwhanmien Kim, MD. PhD contact

+82-31-787-7130

kmkim0070@snubh.org

South Korea1 site, 1 recruiting

Seoul National University
Seongnam-si, Bundang, 13620
Beatrice C Shih, MD, 821091094533, 82430@snubh.org
Kwhanmien Kim, MD.PhD.
Recruiting

Other trials in South Korea

About this study

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

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 24.7-50% 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.

Conditions: Lung Cancer, Vagus Nerve Injuries, Cough
Being tested: Pulmonary branch of vagus nerve preserved, Pulmonary branch of vagus nerve not preserved
Medical subject headings: Lung Neoplasms, Vagus Nerve Injuries, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulmonary branch of vagus nerve preservedProcedure or surgery
During the mediastinal lymph node dissection using minimally invasive surgery, efforts to preserve the pulmonary branch of vagus nerve is made.
Pulmonary branch of vagus nerve not preservedProcedure or surgery
During the mediastinal lymph node dissection using minimally invasive surgery, efforts to preserve the pulmonary branch of vagus nerve is not made/ can be severed.

Study groups in NCT04923412
Study group	Role	What they receive
Pulmonary branch of vagus nerve preserved	Experimental	Pulmonary branch of vagus nerve is preserved during the mediastinal lymph node dissection using minimally invasive surgery Receives: Procedure: Pulmonary branch of vagus nerve preserved
Pulmonary branch of vagus nerve not-preserved	Experimental	Pulmonary branch of vagus nerve is not preserved during the mediastinal lymph node dissection using minimally invasive surgery Receives: Procedure: Pulmonary branch of vagus nerve not preserved

What is being measured

The primary outcome is the main question the study is designed to answer.

Qualitative measurement of postoperative cough
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Measured: Preoperative day
Qualitative measurement of postoperative cough
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Measured: Postoperative day (discharge day, an average of 1 week)
Qualitative measurement of postoperative cough
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Measured: Postoperative 1 month follow up at outpatient clinic
Qualitative measurement of postoperative cough
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Measured: Postoperative 2 month follow up at outpatient clinic
Qualitative measurement of postoperative cough
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Measured: Postoperative 6 month follow up at outpatient clinic
Qualitative measurement of postoperative cough
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Measured: Postoperative 12 month follow up at outpatient clinic
Quantitative measurement of postoperative cough
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Measured: Preoperative day
Quantitative measurement of postoperative cough
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Measured: Postoperative day (discharge day, an average of 1 week)
Quantitative measurement of postoperative cough
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Measured: Postoperative 1 month follow up at outpatient clinic
Quantitative measurement of postoperative cough
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Measured: Postoperative 2 month follow up at outpatient clinic
Quantitative measurement of postoperative cough
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Measured: Postoperative 6 month follow up at outpatient clinic
Quantitative measurement of postoperative cough
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Measured: Postoperative 12 month follow up at outpatient clinic

Secondary outcomes (10)

Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Measurement of TRPA1 (ng/mL), TRPV1 (ng/mL), bradykinin (pg/mL), PGE2 (pg/mL) (released from C-fibers) via enzyme-linked immunosorbent assay (ELISA) test to quantitatively measure the injures of the vagus nerve during the mediastinal lymph node dissection.
Measured: Preoperative day
Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Measurement of TRPA1 (ng/mL), TRPV1 (ng/mL), bradykinin (pg/mL), PGE2 (pg/mL) (released from C-fibers) via enzyme-linked immunosorbent assay (ELISA) test to quantitatively measure the injures of the vagus nerve during the mediastinal lymph node dissection.
Measured: Postoperative 1 day
Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Measurement of TRPA1 (ng/mL), TRPV1 (ng/mL), bradykinin (pg/mL), PGE2 (pg/mL) (released from C-fibers) via enzyme-linked immunosorbent assay (ELISA) test to quantitatively measure the injures of the vagus nerve during the mediastinal lymph node dissection.
Measured: Postoperative 2 month follow up at outpatient clinic
Pulmonary function test
Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
Measured: Preoperative day
Pulmonary function test
Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
Measured: Postoperative 1 month follow up at outpatient clinic
Pulmonary function test
Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
Measured: Postoperative 2 month follow up at outpatient clinic
Pulmonary function test
Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
Measured: Postoperative 6 month follow up at outpatient clinic
Pulmonary function test
Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
Measured: Postoperative 12 month follow up at outpatient clinic
Incidence of postoperative pulmonary complications, hospital stay and readmission, ICU care
Measured: from admission for operation to until the date of first documented postoperative complication or readmission, whichever came first), assessed up to 30 days
Histopathologic review of the total number of mediastinal lymph node dissected
Total number of dissected mediastinal lymph nodes and metastatic lymph nodes will be analyzed. Patient's preoperative clinical N stage and pathologic N stage will be compared; if pathologic N stage is higher than that of the clinical N stage, it will be considered as nodal upstaging.
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202130 Jun 2023

First posted11 Jun 2021
Study start1 Jul 2021
Primary completion30 Jun 2023 (estimated)
Study completion30 Jun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 214 patients will be divided into two groups. 1. Control group (N=107): Effort to preserve the pulmonary branch of vagus nerve preservation is not made in this group during mediastinal lymph node dissection 2. Treatment group (N=107): Effort to preserve the pulmonary branch of vagus nerve preservation is made in this group during mediastinal lymph node dissection
Masking: None (open label)
Enrolment: 214 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04923412
Sponsor's protocol ID: B-2007-625-007
Status last verified: Oct 2022
First submitted: 23 May 2021
Last updated: 26 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kwon JW, Moon JY, Kim SH, Song WJ, Kim MH, Kang MG, Lim KH, Lee SH, Lee SM, Lee JY, Kwon HS, Kim KM, Kim SH, Kim SH, Jeong JW, Kim CW, Cho SH, Lee BJ; Work Group for Chronic Cough, the Korean Academy of Asthma, Allergy and Clinical Immunology. Reliability and validity of a korean version of the leicester cough questionnaire. Allergy Asthma Immunol Res. 2015 May;7(3):230-3. doi: 10.4168/aair.2015.7.3.230. Epub 2014 Dec 18.
PubMed 25749761
Al-Shamlan F, El-Hashim AZ. Bradykinin sensitizes the cough reflex via a B2 receptor dependent activation of TRPV1 and TRPA1 channels through metabolites of cyclooxygenase and 12-lipoxygenase. Respir Res. 2019 Jun 6;20(1):110. doi: 10.1186/s12931-019-1060-8.
PubMed 31170972
Chen S, Huang S, Yu S, Han Z, Gao L, Shen Z, Kang M. The clinical value of a new method of functional lymph node dissection in video-assisted thoracic surgery right non-small cell lung cancer radical resection. J Thorac Dis. 2019 Feb;11(2):477-487. doi: 10.21037/jtd.2019.01.15.
PubMed 30962991
Huang J, Luo Q, Tan Q, Lin H, Qian L, Ding Z. Evaluation of the surgical fat-filling procedure in the treatment of refractory cough after systematic mediastinal lymphadenectomy in patients with right lung cancer. J Surg Res. 2014 Apr;187(2):490-5. doi: 10.1016/j.jss.2013.10.062. Epub 2013 Nov 5.
PubMed 24300131
Lin R, Che G. Risk factors of cough in non-small cell lung cancer patients after video-assisted thoracoscopic surgery. J Thorac Dis. 2018 Sep;10(9):5368-5375. doi: 10.21037/jtd.2018.08.54.
PubMed 30416784
Liu Z, Liu Y, Xie C, Yang J, Zeng B, Yeung SJ, Cheng C. Vagus nerve and phrenic nerve guided systematic nodal dissection for lung cancer. J Thorac Dis. 2019 Sep;11(9):4021-4027. doi: 10.21037/jtd.2019.08.80. No abstract available.
PubMed 31656677
Poghosyan H, Sheldon LK, Leveille SG, Cooley ME. Health-related quality of life after surgical treatment in patients with non-small cell lung cancer: a systematic review. Lung Cancer. 2013 Jul;81(1):11-26. doi: 10.1016/j.lungcan.2013.03.013. Epub 2013 Apr 4.
PubMed 23562675
Sarna L, Evangelista L, Tashkin D, Padilla G, Holmes C, Brecht ML, Grannis F. Impact of respiratory symptoms and pulmonary function on quality of life of long-term survivors of non-small cell lung cancer. Chest. 2004 Feb;125(2):439-45. doi: 10.1378/chest.125.2.439.
PubMed 14769722
Sawabata N, Maeda H, Takeda S, Inoue M, Koma M, Tokunaga T, Matsuda H. Persistent cough following pulmonary resection: observational and empiric study of possible causes. Ann Thorac Surg. 2005 Jan;79(1):289-93. doi: 10.1016/j.athoracsur.2004.06.045.
PubMed 15620960
Spinou A, Birring SS. An update on measurement and monitoring of cough: what are the important study endpoints? J Thorac Dis. 2014 Oct;6(Suppl 7):S728-34. doi: 10.3978/j.issn.2072-1439.2014.10.08.
PubMed 25383207
Watanabe A, Nakazawa J, Miyajima M, Harada R, Nakashima S, Mawatari T, Higami T. Thoracoscopic mediastinal lymph node dissection for lung cancer. Semin Thorac Cardiovasc Surg. 2012 Spring;24(1):68-73. doi: 10.1053/j.semtcvs.2012.03.002.
PubMed 22643666
Yang P, Cheville AL, Wampfler JA, Garces YI, Jatoi A, Clark MM, Cassivi SD, Midthun DE, Marks RS, Aubry MC, Okuno SH, Williams BA, Nichols FC, Trastek VF, Sugimura H, Sarna L, Allen MS, Deschamps C, Sloan JA. Quality of life and symptom burden among long-term lung cancer survivors. J Thorac Oncol. 2012 Jan;7(1):64-70. doi: 10.1097/JTO.0b013e3182397b3e.
PubMed 22134070
Zhu YF, Wu SB, Zhou MQ, Xie MR, Xiong R, Xu SB, Xu GW. Increased expression of TRPV1 in patients with acute or chronic cough after lung cancer surgery. Thorac Cancer. 2019 Apr;10(4):988-991. doi: 10.1111/1759-7714.13042. Epub 2019 Mar 18.
PubMed 30883022

Want to know more?

Kwhanmien Kim, MD. PhD

+82-31-787-7130

kmkim0070@snubh.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04923412
Acronym / sponsor ID: B-2007-625-007
Conditions: Lung Cancer, Vagus Nerve Injuries, Cough
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 214 participants (estimated)
Lead sponsor: Seoul National University Bundang HospitalUniversity, hospital or other
Study start: 1 Jul 2021 (actual)
Primary completion: 30 Jun 2023 (estimated)
Study completion: 30 Jun 2023 (estimated)
First posted: 11 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 214 patients will be divided into two groups. 1. Control group (N=107): Effort to preserve the pulmonary branch of vagus nerve preservation is not made in this group during mediastinal lymph node dissection 2. Treatment group (N=107): Effort to preserve the pulmonary branch of vagus nerve preservation is made in this group during mediastinal lymph node dissection

Arm	Type	Receives
Pulmonary branch of vagus nerve preserved	Experimental	Procedure: Pulmonary branch of vagus nerve preservedPulmonary branch of vagus nerve is preserved during the mediastinal lymph node dissection using minimally invasive surgery
Pulmonary branch of vagus nerve not-preserved	Experimental	Procedure: Pulmonary branch of vagus nerve not preservedPulmonary branch of vagus nerve is not preserved during the mediastinal lymph node dissection using minimally invasive surgery

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study, and can sign the informed consent.
Clinically suspicious of non-small cell lung cancer or tissue confirmed preoperatively
Clinical stage T1-3/N0-1/M0
Preoperative ECOG performance status 0-1
Preoperative ASA class I-III

Key exclusion criteria (11 listed)

Patients who smoked within 2 weeks prior to operation
Patients who received antitussives and expectorants 2 weeks prior to operation
Patients who are pregnant or breast feeding
Patients with severe or uncontrolled psychological disorders
Patients with severe pulmonary adhesion

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulmonary branch of vagus nerve preservedDuring the mediastinal lymph node dissection using minimally invasive surgery, efforts to preserve the pulmonary branch of vagus nerve is made.	Procedure or surgery	Pulmonary branch of vagus nerve preserved
Pulmonary branch of vagus nerve not preservedDuring the mediastinal lymph node dissection using minimally invasive surgery, efforts to preserve the pulmonary branch of vagus nerve is not made/ can be severed.	Procedure or surgery	Pulmonary branch of vagus nerve not-preserved

Primary outcome

Qualitative measurement of postoperative cough
Time frame: Preoperative day
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Qualitative measurement of postoperative cough
Time frame: Postoperative day (discharge day, an average of 1 week)
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Qualitative measurement of postoperative cough
Time frame: Postoperative 1 month follow up at outpatient clinic
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Qualitative measurement of postoperative cough
Time frame: Postoperative 2 month follow up at outpatient clinic
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Qualitative measurement of postoperative cough
Time frame: Postoperative 6 month follow up at outpatient clinic
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Qualitative measurement of postoperative cough
Time frame: Postoperative 12 month follow up at outpatient clinic
Cough Visual Analog Scale (VAS) will be used for survey. The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
Quantitative measurement of postoperative cough
Time frame: Preoperative day
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Quantitative measurement of postoperative cough
Time frame: Postoperative day (discharge day, an average of 1 week)
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Quantitative measurement of postoperative cough
Time frame: Postoperative 1 month follow up at outpatient clinic
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Quantitative measurement of postoperative cough
Time frame: Postoperative 2 month follow up at outpatient clinic
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Quantitative measurement of postoperative cough
Time frame: Postoperative 6 month follow up at outpatient clinic
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.
Quantitative measurement of postoperative cough
Time frame: Postoperative 12 month follow up at outpatient clinic
The Korean version of the Leicester Cough Questionnaire will be used for survey. Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which is a 7 point Likert scale with a minimum value of 1 indicating chronic cough impacts participant life all of the time and a maximum value of 7 indicating chronic cough impacts participant life none of the time.

10 secondary outcomes

Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Time frame: Preoperative day
Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Time frame: Postoperative 1 day
Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Time frame: Postoperative 2 month follow up at outpatient clinic
Pulmonary function test
Time frame: Preoperative day
Pulmonary function test
Time frame: Postoperative 1 month follow up at outpatient clinic
Pulmonary function test
Time frame: Postoperative 2 month follow up at outpatient clinic
Pulmonary function test
Time frame: Postoperative 6 month follow up at outpatient clinic
Pulmonary function test
Time frame: Postoperative 12 month follow up at outpatient clinic
Incidence of postoperative pulmonary complications, hospital stay and readmission, ICU care
Time frame: from admission for operation to until the date of first documented postoperative complication or readmission, whichever came first), assessed up to 30 days
Histopathologic review of the total number of mediastinal lymph node dissected
Time frame: through study completion, an average of 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
Background: PubMed 25749761Kwon JW, Moon JY, Kim SH, Song WJ, Kim MH, Kang MG, Lim KH, Lee SH, Lee SM, Lee JY, Kwon HS, Kim KM, Kim SH, Kim SH, Jeong JW, Kim CW, Cho SH, Lee BJ; Work Group for Chronic Cough, the Korean Academy of Asthma, Allergy and Clinical Immunology. Reliability and validity of a korean version of the leicester cough questionnaire. Allergy Asthma Immunol Res. 2015 May;7(3):230-3. doi: 10.4168/aair.2015.7.3.230. Epub 2014 Dec 18.
Background: PubMed 31170972Al-Shamlan F, El-Hashim AZ. Bradykinin sensitizes the cough reflex via a B2 receptor dependent activation of TRPV1 and TRPA1 channels through metabolites of cyclooxygenase and 12-lipoxygenase. Respir Res. 2019 Jun 6;20(1):110. doi: 10.1186/s12931-019-1060-8.
Background: PubMed 30962991Chen S, Huang S, Yu S, Han Z, Gao L, Shen Z, Kang M. The clinical value of a new method of functional lymph node dissection in video-assisted thoracic surgery right non-small cell lung cancer radical resection. J Thorac Dis. 2019 Feb;11(2):477-487. doi: 10.21037/jtd.2019.01.15.
Background: PubMed 24300131Huang J, Luo Q, Tan Q, Lin H, Qian L, Ding Z. Evaluation of the surgical fat-filling procedure in the treatment of refractory cough after systematic mediastinal lymphadenectomy in patients with right lung cancer. J Surg Res. 2014 Apr;187(2):490-5. doi: 10.1016/j.jss.2013.10.062. Epub 2013 Nov 5.
Background: PubMed 30416784Lin R, Che G. Risk factors of cough in non-small cell lung cancer patients after video-assisted thoracoscopic surgery. J Thorac Dis. 2018 Sep;10(9):5368-5375. doi: 10.21037/jtd.2018.08.54.
Background: PubMed 31656677Liu Z, Liu Y, Xie C, Yang J, Zeng B, Yeung SJ, Cheng C. Vagus nerve and phrenic nerve guided systematic nodal dissection for lung cancer. J Thorac Dis. 2019 Sep;11(9):4021-4027. doi: 10.21037/jtd.2019.08.80. No abstract available.
Background: PubMed 23562675Poghosyan H, Sheldon LK, Leveille SG, Cooley ME. Health-related quality of life after surgical treatment in patients with non-small cell lung cancer: a systematic review. Lung Cancer. 2013 Jul;81(1):11-26. doi: 10.1016/j.lungcan.2013.03.013. Epub 2013 Apr 4.
Background: PubMed 14769722Sarna L, Evangelista L, Tashkin D, Padilla G, Holmes C, Brecht ML, Grannis F. Impact of respiratory symptoms and pulmonary function on quality of life of long-term survivors of non-small cell lung cancer. Chest. 2004 Feb;125(2):439-45. doi: 10.1378/chest.125.2.439.
Background: PubMed 15620960Sawabata N, Maeda H, Takeda S, Inoue M, Koma M, Tokunaga T, Matsuda H. Persistent cough following pulmonary resection: observational and empiric study of possible causes. Ann Thorac Surg. 2005 Jan;79(1):289-93. doi: 10.1016/j.athoracsur.2004.06.045.
Background: PubMed 25383207Spinou A, Birring SS. An update on measurement and monitoring of cough: what are the important study endpoints? J Thorac Dis. 2014 Oct;6(Suppl 7):S728-34. doi: 10.3978/j.issn.2072-1439.2014.10.08.
Background: PubMed 22643666Watanabe A, Nakazawa J, Miyajima M, Harada R, Nakashima S, Mawatari T, Higami T. Thoracoscopic mediastinal lymph node dissection for lung cancer. Semin Thorac Cardiovasc Surg. 2012 Spring;24(1):68-73. doi: 10.1053/j.semtcvs.2012.03.002.
Background: PubMed 22134070Yang P, Cheville AL, Wampfler JA, Garces YI, Jatoi A, Clark MM, Cassivi SD, Midthun DE, Marks RS, Aubry MC, Okuno SH, Williams BA, Nichols FC, Trastek VF, Sugimura H, Sarna L, Allen MS, Deschamps C, Sloan JA. Quality of life and symptom burden among long-term lung cancer survivors. J Thorac Oncol. 2012 Jan;7(1):64-70. doi: 10.1097/JTO.0b013e3182397b3e.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kwhanmien Kim, MD. PhD contact

+82-31-787-7130

kmkim0070@snubh.org

Kwhanmien Kim, MD. PhD study director

Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kwhanmien Kim, MD. PhD (+82-31-787-7130, kmkim0070@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative measurement of postoperative cough (time frame: Preoperative day). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04923412, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.