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Postoperative CoughENERGY-COUGHNCT07524712

Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough

A study testing Energy Device Vagus Nerve Transection and Mechanical Vagus Nerve Transection in people with Postoperative Cough and Cough Hypersensitivity Syndrome, run by Tongji Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Numerous current studies have indicated that transecting the pulmonary plexus nerve as a routine step in radical lung cancer surgery is an independent risk factor for cough hypersensitivity (CH). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Energy Device Vagus Nerve Transection and Mechanical Vagus Nerve Transection
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
1 siteChina
Study dates
1 Sep 2026to 1 Sep 2028
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients scheduled to undergo elective video-assisted thoracoscopic surgery (VATS) for partial resection of the right lung and lymph node sampling between 2025 and 2026;
  • Preoperative examination shows that the maximum diameter of the pulmonary lesion is 2 cm or less (T1), with no hilar or mediastinal lymph node metastasis and no evidence of distant metastasis (M0);
  • ASA grade I-III.

Who cannot join

  • With a respiratory infection in the past 4 weeks, and with a history of chronic cough, chronic bronchitis, bronchiectasis, asthma, rhinitis, gastroesophageal reflux disease, or allergic rhinitis syndrome;
  • Using angiotensin-converting enzyme inhibitors (ACEI);
  • Severe heart disease;
  • Having a history of lung surgery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shu Peng, Medical Doctor contact

+86 18571716422

drpeng90@hotmail.com

Justin Nathen C Federigan contact

+86 15623967709

dr.justinnathen@gmail.com

China1 site
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Preliminary Study on the Associated Mechanisms Between Surgical Instruments and Postoperative Cough

Numerous current studies have indicated that transecting the pulmonary plexus nerve as a routine step in radical lung cancer surgery is an independent risk factor for cough hypersensitivity (CH). However, there are significant disagreements in the thoracic surgery community regarding the strategy for managing the vagus pulmonary plexus, primarily because key clinical issues remain unresolved: How do surgical procedures affect the occurrence and development of CH? And how can these procedures be improved?

A large number of published studies have only analyzed "where to cut" while neglecting the surgical issue of "how to cut". Even with a high level of evidence, the conclusions remain contradictory. This is because doctors' preferences and changes in supply conditions can influence the selection of instruments. Differences in the energy of the instruments can lead to varying degrees and scopes of vagus nerve degeneration and collateral damage to the sympathetic pulmonary plexus, while CH is regulated by both the sympathetic and parasympathetic nervous systems.

Read more

This project intends to explore the correlation between the selection of surgical instruments and the occurrence and development of postoperative CH at the clinical level, providing a reference for optimizing surgical methods and preventing and treating postoperative CH after lung surgery.

The specific research objectives are: to clarify the correlation through a randomized controlled trial, comparing the patterns and changes in the occurrence and development of postoperative CH between two groups of patients whose autonomic nerve pulmonary plexus was transected using energy-based instruments versus mechanical methods.

Optimize the surgical procedure: Based on the above results, propose a safe, effective, and feasible surgical method to reduce intraoperative damage, prevent postoperative CH, and improve patients' quality of life.

Key problems to be solved: How do surgical operations affect the occurrence and development of CH? How can improvements be made?

  1. Clinical issues: ① Do energy-based instruments (causing thermal damage, etc.) and mechanical transection (causing physical damage), which lead to varying degrees of vagus nerve injury and collateral sympathetic nerve damage, affect the occurrence and development of postoperative cough hypersensitivity (CH)? ② How to optimize surgical operations to reduce the incidence of postoperative CH and improve patients' quality of life?
  2. Correlation mechanisms: How do different instruments and energy modes affect the pathophysiology of nerve injury, degeneration, and repair, and what are the correlation patterns and mechanisms between these and the occurrence and development of CH?
Being tested
Energy Device Vagus Nerve Transection, Mechanical Vagus Nerve Transection
Keywords
postoperative cough, persistent cough, surgical instruments, cough hypersensitivity, vagus pulmonary plexus, vagus nerve
Medical subject headings
cough hypersensitivity syndrome, Chronic Cough

What participants receive

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

  • Energy Device Vagus Nerve TransectionDevice

    During the lymph node sampling step, to expose the subcarinal lymph nodes, energy devices (ultrasonic scalpel, electrosurgical knife) will be used to sever the vagus pulmonary plexus.

  • Mechanical Vagus Nerve TransectionDevice

    During the lymph node sampling step, to expose the subcarinal lymph nodes, mechanical sharp dissection (cutting) will be used to sever the vagus pulmonary plexus.

Study groups in NCT07524712
Study groupRoleWhat they receive
Energy Devices GroupExperimentalDuring the lymph node sampling step, to expose the subcarinal lymph nodes, energy devices (ultrasonic scalpel, electrosurgical knife) will be used to sever the vagus pulmonary plexus.
Receives: Device: Energy Device Vagus Nerve Transection
Mechanical Transection GroupActive comparatorDuring the lymph node sampling step, to expose the subcarinal lymph nodes, mechanical sharp dissection (cutting) will be used to sever the vagus pulmonary plexus.
Receives: Device: Mechanical Vagus Nerve Transection

What is being measured

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

  1. PC Severity (Perioperative)

    Cough Symptom Score (CSS score) is recorded on the day and night of the 7-day follow-up. The median cough symptom score is retrieved 7 days after surgery.

    0 is equivalent to no cough during the day/night, while 5 is equivalent to distressing coughs most of the day (or preventing any sleep at night).

    Measured: Day 1, 2, 3, 4, 5, 6, 7 Post-op

  2. PC Pain (Perioperative)

    Visual Analog Scale (VAS score) is recorded on the day of follow-up. The median cough symptom score is retrieved on 7 days after surgery.

    1 is equivalent to no impact, and 10 is equivalent to the most pain.

    Measured: Day 1, 2, 3, 4, 5, 6, 7 Post-op

  3. PC Incidence Effects on QoL (Preoperative)

    The Chinese Mandarin version of the Leicester Cough Questionnaire (LCQ) will be used to compare preoperative and postoperative changes in objective cough frequency and quality of life among patients. It 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: Day 1 Pre-op

Secondary outcomes (11)
  1. PC Severity (Postoperative)

    Cough Symptom Score (CSS score) is recorded on the day and night follow-up. The median is taken on the day of the follow-up.

    0 is equivalent to no cough during the day/night, while 5 is equivalent to distressing coughs most of the day (or preventing any sleep at night).

    Measured: 30th and 90th day post-op

  2. PC Pain (Postoperative)

    Visual Analog Scale (VAS score) is recorded on the day of follow-up. 1 is equivalent to no impact, and 10 is equivalent to the most pain.

    Measured: 30th and 90th day post-op

  3. PC Incidence Effects on QoL (Postoperative)

    The Chinese Mandarin version of the Leicester Cough Questionnaire (LCQ) will be used to compare preoperative and postoperative changes in objective cough frequency and quality of life among patients. It 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: 30th and 90th day post-op

  4. Cough Sensitivity Testing

    Evaluate the level of cough sensitivity by comparing the intensity of stimulating factors (such as concentration, dose, etc.) or the conditions of cough responses (such as frequency, onset time, etc.)

    Measured: 30th and 90th day post-op

  5. Incidence of Gastrointestinal Complications

    Gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, and nausea

    Measured: Within the 90 days post-op

  6. Incidence of Other Complications

    Respiratory complications such as pulmonary infection, atelectasis, pulmonary embolism, pleural effusion, postoperative respiratory failure, and the need for tracheal intubation, as well as other systemic complications including arrhythmia, intestinal obstruction, renal failure, and cerebrovascular accident

    Measured: Within the 30 days post-op

  7. Total Number and Stations of Sampled Lymph Nodes

    Verify that the surgical procedures of the two groups have no impact on the quality of lymph node sampling

    Measured: During surgery

  8. Surgery Duration

    Measured: During surgery

  9. Intubation Time

    Measured: Within the 30 days post-op

  10. Incidence of Re-hospitalization

    Measured: Within the 30 days post-op

  11. Pulmonary Function Test

    FEV1%, FEV1/FVC% (tests to evaluate the impact of vagotomy on lung function)

    Measured: Pre-op, 30th day post-op, 90th day post-op, 120th day post-op, 360th day post-op

Timeline

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

  1. First posted13 Apr 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Lymph nodes are grouped according to the standards of the American Joint Committee on Cancer (AJCC) and sampled in accordance with the NCCN Non-Small Cell Lung Cancer Guidelines (2025). In the right thoracic cavity (groups 4, 7, 9, 10, 11), 2 groups of N1 lymph nodes and 2 groups of N2 lymph nodes are sampled. The posterior mediastinal pleura is opened parallel to the main trunk of the vagus nerve, and the distance between the instrument and the main trunk of the vagus nerve is recorded. During the lymph node sampling step, to expose the subcarinal lymph nodes, energy devices (ultrasonic scalpel, electrosurgical knife) will be used to sever the vagus pulmonary plexus in Group A; while mechanical sharp dissection (cutting) will be used to sever the same plexus in Group B.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
248 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07524712
Sponsor's protocol ID
TJ-IRB202601115
Other IDs
202510487017
Acronym
ENERGY-COUGH
Status last verified
May 2026
First submitted
30 Mar 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In accordance with the institution's data confidentiality requirements

Publications

  • Ruan ZG, Xu CY, Hua LF. A commentary on 'Pulmonary vagus nerve transection for chronic cough after video-assisted lobectomy: a randomized controlled trial'. Int J Surg. 2024 Jul 1;110(7):4524-4525. doi: 10.1097/JS9.0000000000001428. No abstract available.

    PubMed 38597401
  • Zhang Q, Ge Y, Sun T, Feng S, Zhang C, Hong T, Liu X, Han Y, Cao JL, Zhang H. Pulmonary vagus nerve transection for chronic cough after video-assisted lobectomy: a randomized controlled trial. Int J Surg. 2024 Mar 1;110(3):1556-1563. doi: 10.1097/JS9.0000000000001017.

    PubMed 38116674
  • Cheng X, Chen H. Commentary on the impacts of postoperative complications on survival after lung cancer surgery. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1265-1266. doi: 10.1016/j.jtcvs.2017.10.122. Epub 2017 Nov 6. No abstract available.

    PubMed 29198796
  • Weijs TJ, Ruurda JP, Luyer MD, Nieuwenhuijzen GA, van Hillegersberg R, Bleys RL. Topography and extent of pulmonary vagus nerve supply with respect to transthoracic oesophagectomy. J Anat. 2015 Oct;227(4):431-9. doi: 10.1111/joa.12366.

    PubMed 26352410
  • Mazzone SB, Undem BJ. Vagal Afferent Innervation of the Airways in Health and Disease. Physiol Rev. 2016 Jul;96(3):975-1024. doi: 10.1152/physrev.00039.2015.

    PubMed 27279650
  • Barnes PJ. Neurogenic inflammation in the airways. Respir Physiol. 2001 Mar;125(1-2):145-54. doi: 10.1016/s0034-5687(00)00210-3.

    PubMed 11240158
  • Naqvi KF, Mazzone SB, Shiloh MU. Infectious and Inflammatory Pathways to Cough. Annu Rev Physiol. 2023 Feb 10;85:71-91. doi: 10.1146/annurev-physiol-031422-092315. Epub 2022 Sep 28.

    PubMed 36170660
  • Kepicova M, Tulinsky L, Konde A, Dzurnakova P, Ihnat P, Adamica D, Neoral C, Martinek L. Risk Factors and Postoperative Complications of Lobectomy for Non-Small Cell Lung Cancer: An Exploratory Analysis of Premedication and Clinical Variables. Medicina (Kaunas). 2024 Dec 20;60(12):2088. doi: 10.3390/medicina60122088.

    PubMed 39768967
  • Polverino M, Polverino F, Fasolino M, Ando F, Alfieri A, De Blasio F. Anatomy and neuro-pathophysiology of the cough reflex arc. Multidiscip Respir Med. 2012 Jun 18;7(1):5. doi: 10.1186/2049-6958-7-5.

    PubMed 22958367
  • Sun X, Lan Z, Li S, Huang S, Zeng C, Wu J, Chen Q, Chen Y, Chen Z, Tang Y, Qiao G. Trajectories and risk factors of persistent cough after pulmonary resection: A prospective two-center study. Thorac Cancer. 2023 Dec;14(36):3503-3510. doi: 10.1111/1759-7714.15147. Epub 2023 Nov 3.

    PubMed 37920959

Questions about this trial

What is this clinical trial studying?

A study testing Energy Device Vagus Nerve Transection and Mechanical Vagus Nerve Transection in people with Postoperative Cough and Cough Hypersensitivity Syndrome, run by Tongji 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 May 2026. 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 Shu Peng, Medical Doctor (+86 18571716422, drpeng90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PC Severity (Perioperative) (time frame: Day 1, 2, 3, 4, 5, 6, 7 Post-op). The study lists 3 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 NCT07524712, which also lists 10 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 7 May 2026.

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