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AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Rong Zhang, Master contact

+8613808743327

zhangrong00626@126.com

China1 site, 1 recruiting
  • the 920th Hospital of the Joint Logistics Support Force

    Kunming, Yunnan, 223964

    Rong Zhang, +8613808743327, zhangrong00626@126.com

    Recruiting

Other trials in China

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 groups in NCT06476249
Study groupRoleWhat they receive
coughPatients who met the inclusion and exclusion criteria and underwent thoracoscopically assisted pneumonectomy with postoperative cough
Receives: Other: without
UncoughPatients 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.

  1. 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

  2. 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)
  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.

  1. First posted26 Jun 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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)
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

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.

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