Lung CancerNCT06476249
Risk Factors for Postoperative Cough in Patients Undergoing Thoracoscopic Lung Resection
An observational study of Lung Cancer, run by Hematology department of the 920th hospital at 1 site in China.
Trial summary
Lung cancer, as the main cause of cancer-related deaths in both males and females, is a great risk to human health. Pulmonary resection is the most applicable to early-stage lung cancer diagnoses and considered the best curative options. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- without
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants in this study are from the 920th Hospital. Patients aged 18 years or older and less than or equal to 70 years of age who underwent surgery with video-assisted thoracoscopic pneumonectomy.
Who may be able to join
- ● Patients aged 18 years or older and less than or equal to 70 years of age who underwent surgery with video-assisted thoracoscopic pneumonectomy.
Who cannot join
- Pre-existing cough before surgery (e.g. asthma, taking ACEI Drugs, etc.)
- Distant metastasis of tumor
- Combined pregnancy or breastfeeding
- Combined with other systemic major diseases (such as malignant swelling, chronic liver insufficiency, chronic renal insufficiency, etc.)
- Suffering from mental illness
- Refusal of follow-up or incomplete clinical information
- Poor compliance and other groups considered by the investigator not suitable for inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the 920th Hospital of the Joint Logistics Support Force
Kunming, Yunnan, 223964
Rong Zhang, +8613808743327, zhangrong00626@126.com
About this study
Official title: A Prospective Cohort Study on Risk Factors for Postoperative Cough in Patients Undergoing Thoracoscopic Lung Resection
Lung cancer, as the main cause of cancer-related deaths in both males and females, is a great risk to human health. Pulmonary resection is the most applicable to early-stage lung cancer diagnoses and considered the best curative options. Coughing is a prominent symptom among postoperative complications, with approximately 18%-50% of patients experiencing persistent coughing after surgery. This study is a prospective observational study and is expected to be carried out in a large tertiary hospital. This cohort is expected to include 1000 participants for three years.
Patients with pulmonary nodules on chest CT will be divided into two groups based on the presence or absence of cough symptoms on admission. The investigators decided whether to include patients in this cohort study strictly based on the inclusion and exclusion criteria. The severity of cough, the trajectory of cough change, and the physiological and social burden caused by cough will be reflected by the results of LCQ-MC, CSS, HARQ, and VAS. LCQ-MC, CSS, HARQ, and VAS are just a few of the questionnaires that are widely used to investigate the cough and severity of the respondent. The included variables included age, gender, Height, Weight, education level, smoking history, alcohol history, preoperative lung function, nodule size, preoperative and postoperative blood routine (such as white blood cell count, neutrophil count, etc.), blood biochemistry (such as C-reactive protein, PCT, etc.), liver and kidney function test results, surgical method, surgical site, operation duration, anesthesia method, anesthesia duration, lymph node dissection, pathological results, chest tube caliber, number of days of catheterization, use of cough drugs, use of non-steroidal anti-inflammatory drugs, Number of days in hospital and number of outpatient visits due to cough.
Read the detailed description
Lung cancer, as the main cause of cancer-related deaths in both males and females, is a great risk to human health. With the continuous updating of medical equipment and the gradual popularization of lung cancer screening, the detection rate of pulmonary nodules has been greatly improved, and surgical treatment is still the main treatment method for high-risk pulmonary nodules. Pulmonary resection, including wedge resection, segmentectomy and lobectomy, is the most applicable to early-stage lung cancer diagnoses and considered the best curative options.
Coughing is a prominent symptom among postoperative complications, with approximately 18%-50% of patients experiencing persistent coughing after surgery. Persistent cough after pulmonary resection is defined as follows: non-productive cough that occurs more than 2 weeks after pulmonary resection with stable chest roentgenogram results, no evidence of postnasal drip syndrome or asthma, and no angiotensin converting enzyme inhibitor administration. Severe and persistent cough not only increases the difficulty of postoperative lung function exercise for patients, affects the recovery of the surgical site, but also affects their daily life and sleep, increases their physiological and psychological burden, and causes a huge social burden.
However, the reason why cough after pulmonary resection occurs is steal unclear.
CAP can be induced by various factors. According to previous studies, these factors are classified into four types: surgical factors, anesthetic factors, chemical factors, and other factors. The majority studies focus on the surgical factors, and have some points on the risk factors. Several small size studies suggested that mediastinal lymph node dissection may be an independent risk factor for persistent cough after Some studies previously reported that some factors, including surgical factors and gastroesophageal reflux (GER) secondary to the loss of volume after pulmonary resection, may be risky for persistent cough after pulmonary resection.
Vagus nerves and their branches mainly assume the afferent activities arising from sensory terminals which located in the lung and airway. And a vast majority of Vagus nerves and their branches are non-myelinated (C-) fibers.
Under normal or abnormal physiological conditions, the C-fiber locating in the lung and airway plays an important role in regulating the cardiopulmonary functions.
It is extensively documented that the sensitivity of vagal bronchopulmonary C-fibers can be enhanced by injury or inflammation of airway mucosa during both acute and chronic airway diseases. Actually, all afferent C fibers in both the somatosensory and visceral nervous systems can be stimulated by chemical mediators associated with inflammation. Some scholars speculate that it may be related to C-type fibers and inflammatory factors introduced by the vagus nerve. In basic experimental research, DP1, IP, EP1, and EP2 receptors are expressed in C fiber neurons.
This prospective cohort study will describe the incidence of CAP and the trajectory change in cough severity in patients with thoracoscopic lung resection. The primary objective of the study is to explore the risk factors for the development of CAP and to assess the physical, psychological, social, and life burdens of patients with CAP. The secondary objective is to see if the use of nonsteroidal drugs has an effect on the development of CAP. This study aims to provide preliminary evidence and guidance on appropriate treatment of post-pneumonectomy cough and risk factors for persistent cough and non-steroidal pharmacotherapy for CAP.
- Conditions
- Lung Cancer
- Being tested
- without
- Keywords
- cough after pulmonary resection, thoracoscopic lung resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withoutOther
without
| Study group | Role | What they receive |
|---|---|---|
| cough | Patients who met the inclusion and exclusion criteria and underwent thoracoscopically assisted pneumonectomy with postoperative cough Receives: Other: without | |
| Uncough | Patients who met the inclusion and exclusion criteria and underwent thoracoscopically assisted pneumonectomy without postoperative cough Receives: Other: without |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score value of Mandarin Chinese version of the Leicester Cough Questionnaire
Mandarin Chinese version of the Leicester Cough Questionnaire is a globally recognized questionnaire for assessing the severity of cough
Measured: On the 3rd,1 month and Half a year postoperatively
The score value of visual analogue scale
The score value of visual analogue scaleis a globally recognized questionnaire for assessing the severity of cough
Measured: On the 3rd, 7th, 11th, 15th, 1 month, and half a year after surgery, respectively
Secondary outcomes (1)
The score value of Hull airway reflux questionnaire
The score value of visual analogue scaleis a globally recognized questionnaire for assessing the severity of cough
Measured: On the 3rd,1 month and Half a year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hematology department of the 920th hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenk Cai, doctor, Study chair, the Vice-President of the 920th Hospital of the Joint Logistics Support Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476249
- Sponsor's protocol ID
- 202404101CAP
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang R, Yang X, He T, Men B, Nian ZX, Yu J, Zhang YF, Liu XK, Zhang X, He GH, Cai WK. Impact of non-steroidal anti-inflammatory drugs exposure on persistent cough after pulmonary resection in a Chinese tertiary hospital: a prospective cohort study protocol. BMJ Open. 2025 Jun 30;15(6):e096934. doi: 10.1136/bmjopen-2024-096934.
PubMed 40588380
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Risk Factors for Postoperative Cough in Patients Undergoing Thoracoscopic Lung Resection
- ClinicalTrials.gov ID
- NCT06476249
- Acronym / sponsor ID
- 202404101CAP
- Conditions
- Lung Cancer
- Keywords
- cough after pulmonary resection, thoracoscopic lung resection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hematology department of the 920th hospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 26 Jun 2024 (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.
Lung cancer, as the main cause of cancer-related deaths in both males and females, is a great risk to human health. Pulmonary resection is the most applicable to early-stage lung cancer diagnoses and considered the best curative options. Coughing is a prominent symptom among postoperative complications, with approximately 18%-50% of patients experiencing persistent coughing after surgery. This study is a prospective observational study and is expected to be carried out in a large tertiary hospital. This cohort is expected to include 1000 participants for three years.
Patients with pulmonary nodules on chest CT will be divided into two groups based on the presence or absence of cough symptoms on admission. The investigators decided whether to include patients in this cohort study strictly based on the inclusion and exclusion criteria. The severity of cough, the trajectory of cough change, and the physiological and social burden caused by cough will be reflected by the results of LCQ-MC, CSS, HARQ, and VAS. LCQ-MC, CSS, HARQ, and VAS are just a few of the questionnaires that are widely used to investigate the cough and severity of the respondent. The included variables included age, gender, Height, Weight, education level, smoking history, alcohol history, preoperative lung function, nodule size, preoperative and postoperative blood routine (such as white blood cell count, neutrophil count, etc.), blood biochemistry (such as C-reactive protein, PCT, etc.), liver and kidney function test results, surgical method, surgical site, operation duration, anesthesia method, anesthesia duration, lymph node dissection, pathological results, chest tube caliber, number of days of catheterization, use of cough drugs, use of non-steroidal anti-inflammatory drugs, Number of days in hospital and number of outpatient visits due to cough.
Detailed description
Lung cancer, as the main cause of cancer-related deaths in both males and females, is a great risk to human health. With the continuous updating of medical equipment and the gradual popularization of lung cancer screening, the detection rate of pulmonary nodules has been greatly improved, and surgical treatment is still the main treatment method for high-risk pulmonary nodules. Pulmonary resection, including wedge resection, segmentectomy and lobectomy, is the most applicable to early-stage lung cancer diagnoses and considered the best curative options.
Coughing is a prominent symptom among postoperative complications, with approximately 18%-50% of patients experiencing persistent coughing after surgery. Persistent cough after pulmonary resection is defined as follows: non-productive cough that occurs more than 2 weeks after pulmonary resection with stable chest roentgenogram results, no evidence of postnasal drip syndrome or asthma, and no angiotensin converting enzyme inhibitor administration. Severe and persistent cough not only increases the difficulty of postoperative lung function exercise for patients, affects the recovery of the surgical site, but also affects their daily life and sleep, increases their physiological and psychological burden, and causes a huge social burden.
However, the reason why cough after pulmonary resection occurs is steal unclear.
CAP can be induced by various factors. According to previous studies, these factors are classified into four types: surgical factors, anesthetic factors, chemical factors, and other factors. The majority studies focus on the surgical factors, and have some points on the risk factors. Several small size studies suggested that mediastinal lymph node dissection may be an independent risk factor for persistent cough after Some studies previously reported that some factors, including surgical factors and gastroesophageal reflux (GER) secondary to the loss of volume after pulmonary resection, may be risky for persistent cough after pulmonary resection.
Vagus nerves and their branches mainly assume the afferent activities arising from sensory terminals which located in the lung and airway. And a vast majority of Vagus nerves and their branches are non-myelinated (C-) fibers.
Under normal or abnormal physiological conditions, the C-fiber locating in the lung and airway plays an important role in regulating the cardiopulmonary functions.
It is extensively documented that the sensitivity of vagal bronchopulmonary C-fibers can be enhanced by injury or inflammation of airway mucosa during both acute and chronic airway diseases. Actually, all afferent C fibers in both the somatosensory and visceral nervous systems can be stimulated by chemical mediators associated with inflammation. Some scholars speculate that it may be related to C-type fibers and inflammatory factors introduced by the vagus nerve. In basic experimental research, DP1, IP, EP1, and EP2 receptors are expressed in C fiber neurons.
This prospective cohort study will describe the incidence of CAP and the trajectory change in cough severity in patients with thoracoscopic lung resection. The primary objective of the study is to explore the risk factors for the development of CAP and to assess the physical, psychological, social, and life burdens of patients with CAP. The secondary objective is to see if the use of nonsteroidal drugs has an effect on the development of CAP. This study aims to provide preliminary evidence and guidance on appropriate treatment of post-pneumonectomy cough and risk factors for persistent cough and non-steroidal pharmacotherapy for CAP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cough | – | Other: withoutPatients who met the inclusion and exclusion criteria and underwent thoracoscopically assisted pneumonectomy with postoperative cough |
| Uncough | – | Other: withoutPatients who met the inclusion and exclusion criteria and underwent thoracoscopically assisted pneumonectomy without postoperative cough |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants in this study are from the 920th Hospital. Patients aged 18 years or older and less than or equal to 70 years of age who underwent surgery with video-assisted thoracoscopic pneumonectomy.
Key inclusion criteria (1 listed)
- ● Patients aged 18 years or older and less than or equal to 70 years of age who underwent surgery with video-assisted thoracoscopic pneumonectomy.
Key exclusion criteria (7 listed)
- Pre-existing cough before surgery (e.g. asthma, taking ACEI Drugs, etc.)
- Distant metastasis of tumor
- Combined pregnancy or breastfeeding
- Combined with other systemic major diseases (such as malignant swelling, chronic liver insufficiency, chronic renal insufficiency, etc.)
- Suffering from mental illness
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 |
|---|---|---|
| withoutwithout | Other | Uncough, cough |
Primary outcome
The score value of Mandarin Chinese version of the Leicester Cough Questionnaire
Time frame: On the 3rd,1 month and Half a year postoperatively
Mandarin Chinese version of the Leicester Cough Questionnaire is a globally recognized questionnaire for assessing the severity of cough
The score value of visual analogue scale
Time frame: On the 3rd, 7th, 11th, 15th, 1 month, and half a year after surgery, respectively
The score value of visual analogue scaleis a globally recognized questionnaire for assessing the severity of cough
1 secondary outcome
The score value of Hull airway reflux questionnaire
Time frame: On the 3rd,1 month and Half a year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Derived from this study: PubMed 40588380Zhang R, Yang X, He T, Men B, Nian ZX, Yu J, Zhang YF, Liu XK, Zhang X, He GH, Cai WK. Impact of non-steroidal anti-inflammatory drugs exposure on persistent cough after pulmonary resection in a Chinese tertiary hospital: a prospective cohort study protocol. BMJ Open. 2025 Jun 30;15(6):e096934. doi: 10.1136/bmjopen-2024-096934.
- 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.
Wenk Cai, doctor study chair
the Vice-President of the 920th Hospital of the Joint Logistics Support Force
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Hematology department of the 920th hospital at 1 site in China.
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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Jun 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Zhang, Master (+8613808743327, zhangrong00626@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score value of Mandarin Chinese version of the Leicester Cough Questionnaire (time frame: On the 3rd,1 month and Half a year postoperatively). The study lists 2 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 NCT06476249, which also lists 1 linked publication.
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 28 Jun 2024.