Effect of Bronchial Artery Protection on Cough After Thoracoscopic Lobectomy
Primary Purpose
Cough
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery
Sponsored by
About this trial
This is an interventional prevention trial for Cough focused on measuring Bronchial artery, Postoperative cough, three-dimensional reconstruction, Thoracoscopic surgery
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Li Chang
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bronchial artery protection
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04651686
First Posted
November 22, 2020
Last Updated
November 25, 2020
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT04651686
Brief Title
Effect of Bronchial Artery Protection on Cough After Thoracoscopic Lobectomy
Official Title
Effect of Preoperative Three-dimensional Reconstruction and Intraoperative Protection of Bronchial Artery on Cough After Thoracoscopic Pneumonectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
Bronchial artery, Postoperative cough, three-dimensional reconstruction, Thoracoscopic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bronchial artery protection
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of postoperative cough
Description
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.
Time Frame
It lasted for 14 days from the first day to two weeks after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhao
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Study Director
Facility Information:
Facility Name
Li Chang
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
20501731
Citation
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.
Results Reference
background
PubMed Identifier
31807508
Citation
Zhang 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.
Results Reference
background
PubMed Identifier
21678246
Citation
Anuradha 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.
Results Reference
background
PubMed Identifier
30883022
Citation
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.
Results Reference
background
PubMed Identifier
8560389
Citation
Funami 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.
Results Reference
background
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Effect of Bronchial Artery Protection on Cough After Thoracoscopic Lobectomy
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