CoughNCT04651686
Effect of Bronchial Artery Protection on Cough After Thoracoscopic Lobectomy
A study testing Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery in people with Cough, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The postoperative complications of thoracoscopic radical surgery for lung cancer mainly include postoperative bleeding, pulmonary infection, chylothorax, nerve injury, pulmonary embolism, arrhythmia, postoperative cough, bronchopleural fistula and so on. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cough
- What is being tested?
- Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Nov 2020
- 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
- Age ≥ 18 years, no matter male or female;No cough symptoms within two weeks before operation; Lung adenocarcinoma confirmed by pathology;Operation method: thoracoscopic lobectomy + systematic lymph node dissection；Preoperative abdominal B-ultrasound, skull CT / MRI, bone scan or PET / CT to exclude distant metastasis; ECG, lung function, cardiac ultrasound evaluation can tolerate the operation
Who cannot join
- There were cough caused by respiratory diseases, pharyngitis and rhinitis before operation; Pneumonia was indicated by chest X-ray or chest CT in recent month;Thoracoscopic surgery was converted to thoracotomy;Pulmonary arteriovenous angiography could not be performed in patients with allergy to contrast medium; Patients and their families refused to be enrolled and followed up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Three-dimensional Reconstruction and Intraoperative Protection of Bronchial Artery on Cough After Thoracoscopic Pneumonectomy
The postoperative complications of thoracoscopic radical surgery for lung cancer mainly include postoperative bleeding, pulmonary infection, chylothorax, nerve injury, pulmonary embolism, arrhythmia, postoperative cough, bronchopleural fistula and so on. Among them, postoperative cough is one of the most common complications after lung surgery, and the incidence of postoperative cough is 25% - 50%. Cough after pneumonectomy can last for a long time, which affects the rapid recovery of patients after surgery, and brings serious adverse effects to the physiological, psychological and social functions of patients.
Read the detailed description
After pneumonectomy cough on patients' daily life will bring different degrees of adverse effects, so through certain methods to intervene, in order to reduce the incidence of postoperative cough, accelerate the rapid recovery of patients after surgery, improve the quality of life of patients, which should also be worthy of attention of surgeons. In recent years, the research on intervention measures and treatment methods to reduce cough after thoracoscopic lobectomy is mainly focused on drug treatment, traditional Chinese medicine treatment, surgical operation and anesthesia intervention. However, the research on reducing postoperative cough by improving surgical operation is rare. The purpose of this prospective study was to investigate whether preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery can reduce the severity of cough after thoracoscopic lobectomy, so as to further explore the effective intervention measures of postoperative cough and enrich the concept of accelerated rehabilitation surgery.
- Conditions
- Cough
- Being tested
- Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery
- Keywords
- Bronchial artery, Postoperative cough, three-dimensional reconstruction, Thoracoscopic surgery
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative three-dimensional reconstruction and intraoperative protection of bronchial arteryOther
All patients underwent chest enhanced CT examination with 64 slice spiral CT before operation. The bronchial artery was reconstructed by Mimics software. The bronchial artery was protected according to the preoperative three-dimensional reconstruction image during the lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Bronchial artery protection | Experimental | All patients underwent chest enhanced CT examination with 64 slice spiral CT before operation. The bronchial artery was reconstructed by Mimics software. The bronchial artery was protected according to the preoperative three-dimensional reconstruction image during the lymph node dissection Receives: Other: Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative cough
Cough visual analogue scale (VAS) was used to evaluate the diagnosis of cough. Vas is a linear scoring method, using 0-100 mm scale, 0 means no cough, 100 means the most serious cough. Patients are required to mark the severity of cough on the scale line according to their own perception of cough, and measure the distance from the starting point to the marking point as a score. The higher the score is, the more serious the cough is. When the scale reaches 60mm, the patient can be diagnosed as postoperative cough.
Measured: It lasted for 14 days from the first day to two weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Aug 2020
- Primary completion30 Sep 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sixty patients with thoracoscopic lobectomy and systemic lymph node dissection were selected from the same surgical group in the thoracic surgery department of the First Affiliated Hospital of Suzhou University from August 1, 2020 to October 31, 2020. According to the random number grouping method, they were divided into two groups: the bronchial artery protection group (the experimental group) and the conventional surgical treatment group (the control group). In the experimental group, 64 slice spiral CT was used for chest enhanced CT examination before operation, and mimics software was used for 3D reconstruction of bronchial artery. During the operation, the bronchial artery was protected according to the preoperative three-dimensional reconstruction image during lymph node dissection. In the control group, three-dimensional reconstruction of bronchial artery was not performed before operation, and lobectomy and systematic lymph node dissection were performed routinely
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Zhao, Study director, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651686
- Sponsor's protocol ID
- 20201114
- Status last verified
- Nov 2020
- First submitted
- 22 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morita Y, Takase K, Ichikawa H, Yamada T, Sato A, Higano S, Takahashi S. Bronchial artery anatomy: preoperative 3D simulation with multidetector CT. Radiology. 2010 Jun;255(3):934-43. doi: 10.1148/radiol.10081220.
PubMed 20501731Zhang M, Liu D, Wu W, Zhang H, Mao N. Preoperative 3D-CT bronchography and angiography facilitates single-direction uniportal thoracoscopic anatomic lobectomy. Ann Transl Med. 2019 Oct;7(20):526. doi: 10.21037/atm.2019.09.135.
PubMed 31807508Anuradha C, Shyamkumar NK, Vinu M, Babu NR, Christopher DJ. Outcomes of bronchial artery embolization for life-threatening hemoptysis due to tuberculosis and post-tuberculosis sequelae. Diagn Interv Radiol. 2012 Jan-Feb;18(1):96-101. doi: 10.4261/1305-3825.DIR.3876-11.2. Epub 2011 Jun 15.
PubMed 21678246Zhu 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 30883022Funami Y, Okuyama K, Shimada Y, Isono K. Anatomic study of the bronchial arteries with special reference to their preservation during the radical dissection of the upper mediastinum lymph nodes. Surgery. 1996 Jan;119(1):67-75. doi: 10.1016/s0039-6060(96)80216-9.
PubMed 8560389
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Three-dimensional Reconstruction and Intraoperative Protection of Bronchial Artery on Cough After Thoracoscopic Pneumonectomy
- ClinicalTrials.gov ID
- NCT04651686
- Acronym / sponsor ID
- 20201114
- Conditions
- Cough
- Keywords
- Bronchial artery, Postoperative cough, three-dimensional reconstruction, Thoracoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 3 Dec 2020 (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.
The postoperative complications of thoracoscopic radical surgery for lung cancer mainly include postoperative bleeding, pulmonary infection, chylothorax, nerve injury, pulmonary embolism, arrhythmia, postoperative cough, bronchopleural fistula and so on. Among them, postoperative cough is one of the most common complications after lung surgery, and the incidence of postoperative cough is 25% - 50%. Cough after pneumonectomy can last for a long time, which affects the rapid recovery of patients after surgery, and brings serious adverse effects to the physiological, psychological and social functions of patients.
Detailed description
After pneumonectomy cough on patients' daily life will bring different degrees of adverse effects, so through certain methods to intervene, in order to reduce the incidence of postoperative cough, accelerate the rapid recovery of patients after surgery, improve the quality of life of patients, which should also be worthy of attention of surgeons. In recent years, the research on intervention measures and treatment methods to reduce cough after thoracoscopic lobectomy is mainly focused on drug treatment, traditional Chinese medicine treatment, surgical operation and anesthesia intervention. However, the research on reducing postoperative cough by improving surgical operation is rare. The purpose of this prospective study was to investigate whether preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery can reduce the severity of cough after thoracoscopic lobectomy, so as to further explore the effective intervention measures of postoperative cough and enrich the concept of accelerated rehabilitation surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sixty patients with thoracoscopic lobectomy and systemic lymph node dissection were selected from the same surgical group in the thoracic surgery department of the First Affiliated Hospital of Suzhou University from August 1, 2020 to October 31, 2020. According to the random number grouping method, they were divided into two groups: the bronchial artery protection group (the experimental group) and the conventional surgical treatment group (the control group). In the experimental group, 64 slice spiral CT was used for chest enhanced CT examination before operation, and mimics software was used for 3D reconstruction of bronchial artery. During the operation, the bronchial artery was protected according to the preoperative three-dimensional reconstruction image during lymph node dissection. In the control group, three-dimensional reconstruction of bronchial artery was not performed before operation, and lobectomy and systematic lymph node dissection were performed routinely
| Arm | Type | Receives |
|---|---|---|
| Bronchial artery protection | Experimental | Other: Preoperative three-dimensional reconstruction and intraoperative protection of bronchial arteryAll patients underwent chest enhanced CT examination with 64 slice spiral CT before operation. The bronchial artery was reconstructed by Mimics software. The bronchial artery was protected according to the preoperative three-dimensional reconstruction image during the lymph node dissection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years, no matter male or female;No cough symptoms within two weeks before operation; Lung adenocarcinoma confirmed by pathology;Operation method: thoracoscopic lobectomy + systematic lymph node dissection；Preoperative abdominal B-ultrasound, skull CT / MRI, bone scan or PET / CT to exclude distant metastasis; ECG, lung function, cardiac ultrasound evaluation can tolerate the operation
Key exclusion criteria (1 listed)
- There were cough caused by respiratory diseases, pharyngitis and rhinitis before operation; Pneumonia was indicated by chest X-ray or chest CT in recent month;Thoracoscopic surgery was converted to thoracotomy;Pulmonary arteriovenous angiography could not be performed in patients with allergy to contrast medium; Patients and their families refused to be enrolled and followed up.
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 |
|---|---|---|
| Preoperative three-dimensional reconstruction and intraoperative protection of bronchial arteryAll patients underwent chest enhanced CT examination with 64 slice spiral CT before operation. The bronchial artery was reconstructed by Mimics software. The bronchial artery was protected according to the preoperative three-dimensional reconstruction image during the lymph node dissection | Other | Bronchial artery protection |
Primary outcome
Incidence of postoperative cough
Time frame: It lasted for 14 days from the first day to two weeks after operation
Cough visual analogue scale (VAS) was used to evaluate the diagnosis of cough. Vas is a linear scoring method, using 0-100 mm scale, 0 means no cough, 100 means the most serious cough. Patients are required to mark the severity of cough on the scale line according to their own perception of cough, and measure the distance from the starting point to the marking point as a score. The higher the score is, the more serious the cough is. When the scale reaches 60mm, the patient can be diagnosed as postoperative cough.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Background: PubMed 20501731Morita Y, Takase K, Ichikawa H, Yamada T, Sato A, Higano S, Takahashi S. Bronchial artery anatomy: preoperative 3D simulation with multidetector CT. Radiology. 2010 Jun;255(3):934-43. doi: 10.1148/radiol.10081220.
- Background: PubMed 31807508Zhang M, Liu D, Wu W, Zhang H, Mao N. Preoperative 3D-CT bronchography and angiography facilitates single-direction uniportal thoracoscopic anatomic lobectomy. Ann Transl Med. 2019 Oct;7(20):526. doi: 10.21037/atm.2019.09.135.
- Background: PubMed 21678246Anuradha C, Shyamkumar NK, Vinu M, Babu NR, Christopher DJ. Outcomes of bronchial artery embolization for life-threatening hemoptysis due to tuberculosis and post-tuberculosis sequelae. Diagn Interv Radiol. 2012 Jan-Feb;18(1):96-101. doi: 10.4261/1305-3825.DIR.3876-11.2. Epub 2011 Jun 15.
- Background: PubMed 30883022Zhu 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.
- Background: PubMed 8560389Funami Y, Okuyama K, Shimada Y, Isono K. Anatomic study of the bronchial arteries with special reference to their preservation during the radical dissection of the upper mediastinum lymph nodes. Surgery. 1996 Jan;119(1):67-75. doi: 10.1016/s0039-6060(96)80216-9.
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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.
Jun Zhao study director
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery in people with Cough, run by The First Affiliated Hospital of Soochow University 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 1 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: finished, as of the sponsor's last update on 3 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative cough (time frame: It lasted for 14 days from the first day to two weeks after operation). 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 NCT04651686, which also lists 5 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 3 Dec 2020.