NCT04651686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
Last Updated

December 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 22, 2020

Last Update Submit

November 25, 2020

Conditions

Keywords

Bronchial arteryPostoperative coughthree-dimensional reconstructionThoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    It lasted for 14 days from the first day to two weeks after operation

Study Arms (1)

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

Other: Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery

Interventions

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

Bronchial artery protection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Li Chang

Suzhou, Jiangsu, 215006, China

Location

Related Publications (5)

  • 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.

    PMID: 20501731BACKGROUND
  • 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.

    PMID: 31807508BACKGROUND
  • 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.

    PMID: 21678246BACKGROUND
  • 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.

    PMID: 30883022BACKGROUND
  • 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.

    PMID: 8560389BACKGROUND

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jun Zhao

    The First Affiliated Hospital of Soochow University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2020

First Posted

December 3, 2020

Study Start

August 1, 2020

Primary Completion

September 30, 2020

Study Completion

November 1, 2020

Last Updated

December 3, 2020

Record last verified: 2020-11

Locations