Lung DiseasesNCT04012554

The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung

A study testing avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung and Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung in people with Lung Diseases, run by Xueying Yang at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This is a prospective randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after Video-Assisted Thoracoscopic Surgery lung disease,participants were randomly divided into experimental group and control group.Avoiding chest tube placement after VATS of the… Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Lung Diseases
What is being tested?: avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung and Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: 1 Jun 2019to 1 Jul 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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1.Age ranges from 18 to 75 years old,do the examination of chest CT showed pulmonary disease,no invasion of peripheral blood vessels and viscera,no pleural effusion and pericardial effusion.
2.Electrocardiogram, pulmonary function,color doppler ultrasound of the heart,arteries and veins of both lower limbs are normal,no potential infection was confirmed before surgery, no serious organic disease of the heart and lung,and no obvious operation contrain.

Who cannot join

1.The lungs continue to leak air preoperation more than six days. 2.The appearment of the hemothorax,empyema and chylothorax preoperative. 3.The appearment of the preoperative chest X-ray pulmonary atelectasis and pulmonary infection.
4.The lungs leak air appears in the surgery. 5.Patients with severe cardiovascular and cerebrovascular accident after operation were terminated.
6.Impaired lung function (forced expiratory volume in 1 second [FEV1]<60% predicted).

Trial locations and contacts

1 site in 1 country.

Xueying Yang, M.D. contact

86-24-62255001

yangxy@sj-hospital.org

China1 site, 1 recruiting

The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110004
Xueying Yang, M.D.
Recruiting

Other trials in China

About this study

Read the detailed description

This is a prospective randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after VATS of the lung,divided into experiment group and control group.Communicating with surgeon and patients who met the inclusion criteria,decided whether to enter the experimental group or control group. Experimental group avoid chest tube placement after VATS of the lung and control group indwell thoracic drainage tube after VATS of the lung.By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the treatment of avoiding chest tube placement after VATS of the lung is more beneficial than the conventional indwell thoracic drainage tube after VATS of the lung,and it's safe and feasible.

Conditions: Lung Diseases
Being tested: avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung, Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung
Keywords: Postoperative pain, Avoiding chest drainage placement, Hospital cost
Medical subject headings: Lung Diseases, Pain, Postoperative

What participants receive

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

avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lungProcedure or surgery
Avoiding chest drainage tube placement after VATS of the lung in the experiment group.
Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lungProcedure or surgery
Indewlling chest drainage tube after VATS of lung in the control group.

Study groups in NCT04012554
Study group	Role	What they receive
avoiding chest drainage tube placement after resection of lung	Experimental	This group of patients underwent avoiding chest drainage tube placement after VATS of the lung. Receives: Procedure: avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung
indewlling chest drainage tube after resection of lung	Other	This group of patients underwent indewlling chest drainage tube after VATS of the lung. Receives: Procedure: Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung

What is being measured

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

operation time
From the beginnning of ansesthesia to the end of anesthesia
Measured: 1 day
hospitalization expenses
the total cost of hospitalzation
Measured: 15 days
postoperative complication rate
incidence of postoperative complications such as pneumothorax and hydrohorax
Measured: a month
duration of postoperation pain
postoperative pain duration
Measured: 10 days
VAS pain scores
the VAS pain score was given to patients and the pain scores were recorded at 6h,12h,24h,48h,and 72h postoperatively.The minimum score is 0 and the maximum score is 10.The high values represent a worse outcome.
Measured: 3 days
the time of early ambulation after operation
the time from the patient's postoperative pushback to the first bedtime
Measured: 1 day
postoperative extubation time
postoperative extubation time
Measured: 1 day

Timeline

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

1 Jun 20191 Jul 2020

First posted9 Jul 2019
Study start1 Jun 2019
Primary completion1 Jun 2020 (estimated)
Study completion1 Jul 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Lung DiseasesStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after VATS of the lung,participants were divided into experimental group and control group.Avoiding chest tube placement after VATS of the lung in the experimental group.Indwelling thoracic drainage tube after VATS of the lung in the control group.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04012554
Sponsor's protocol ID: EC-2019-HY-023
Status last verified: Oct 2019
First submitted: 2 Jul 2019
Last updated: 8 Oct 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: hospital cost and complications of postoperation

Publications

Nakashima S, Watanabe A, Mishina T, Obama T, Mawatari T, Higami T. Feasibility and safety of postoperative management without chest tube placement after thoracoscopic wedge resection of the lung. Surg Today. 2011 Jun;41(6):774-9. doi: 10.1007/s00595-010-4346-5. Epub 2011 May 28.
PubMed 21626321
Holbek BL, Hansen HJ, Kehlet H, Petersen RH. Thoracoscopic pulmonary wedge resection without post-operative chest drain: an observational study. Gen Thorac Cardiovasc Surg. 2016 Oct;64(10):612-7. doi: 10.1007/s11748-016-0692-6. Epub 2016 Aug 10.
PubMed 27510705
Li P, Shen C, Wu Y, Lai Y, Zhou K, Che G. It is safe and feasible to omit the chest tube postoperatively for selected patients receiving thoracoscopic pulmonary resection: a meta-analysis. J Thorac Dis. 2018 May;10(5):2712-2721. doi: 10.21037/jtd.2018.04.75.
PubMed 29997933
Filosso PL, Sandri A, Guerrera F, Roffinella M, Bora G, Solidoro P. Management of Chest Drains After Thoracic Resections. Thorac Surg Clin. 2017 Feb;27(1):7-11. doi: 10.1016/j.thorsurg.2016.08.002.
PubMed 27865329
Russo L, Wiechmann RJ, Magovern JA, Szydlowski GW, Mack MJ, Naunheim KS, Landreneau RJ. Early chest tube removal after video-assisted thoracoscopic wedge resection of the lung. Ann Thorac Surg. 1998 Nov;66(5):1751-4. doi: 10.1016/s0003-4975(98)00946-1.
PubMed 9875783
Lu TY, Chen JX, Chen PR, Lin YS, Chen CK, Kao PY, Huang TM, Fang HY. Evaluation of the necessity for chest drain placement following thoracoscopic wedge resection. Surg Today. 2017 May;47(5):606-610. doi: 10.1007/s00595-016-1414-5. Epub 2016 Sep 29.
PubMed 27688029
Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. doi: 10.1016/j.ejcts.2004.01.041.
PubMed 15082297
Deng B, Qian K, Zhou JH, Tan QY, Wang RW. Optimization of Chest Tube Management to Expedite Rehabilitation of Lung Cancer Patients After Video-Assisted Thoracic Surgery: A Meta-Analysis and Systematic Review. World J Surg. 2017 Aug;41(8):2039-2045. doi: 10.1007/s00268-017-3975-x.
PubMed 28289835
Chiappetta M, Lococo F, Nachira D, Ciavarella LP, Congedo MT, Porziella V, Meacci E, Margaritora S. Digital Devices Improve Chest Tube Management: Results from a Prospective Randomized Trial. Thorac Cardiovasc Surg. 2018 Oct;66(7):595-602. doi: 10.1055/s-0037-1607443. Epub 2017 Oct 27.
PubMed 29078230

Want to know more?

Xueying Yang, M.D.

86-24-62255001

yangxy@sj-hospital.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

All Lung Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung
ClinicalTrials.gov ID: NCT04012554
Acronym / sponsor ID: EC-2019-HY-023
Conditions: Lung Diseases
Keywords: Postoperative pain, Avoiding chest drainage placement, Hospital cost
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Xueying YangUniversity, hospital or other
Study start: 1 Jun 2019 (actual)
Primary completion: 1 Jun 2020 (estimated)
Study completion: 1 Jul 2020 (estimated)
First posted: 9 Jul 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: This is a randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after VATS of the lung,participants were divided into experimental group and control group.Avoiding chest tube placement after VATS of the lung in the experimental group.Indwelling thoracic drainage tube after VATS of the lung in the control group.

Arm	Type	Receives
avoiding chest drainage tube placement after resection of lung	Experimental	Procedure: avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lungThis group of patients underwent avoiding chest drainage tube placement after VATS of the lung.
indewlling chest drainage tube after resection of lung	Other	Procedure: Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lungThis group of patients underwent indewlling chest drainage tube after VATS of the lung.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

1.Age ranges from 18 to 75 years old,do the examination of chest CT showed pulmonary disease,no invasion of peripheral blood vessels and viscera,no pleural effusion and pericardial effusion.
2.Electrocardiogram, pulmonary function,color doppler ultrasound of the heart,arteries and veins of both lower limbs are normal,no potential infection was confirmed before surgery, no serious organic disease of the heart and lung,and no obvious operation contrain.

Key exclusion criteria (3 listed)

1.The lungs continue to leak air preoperation more than six days. 2.The appearment of the hemothorax,empyema and chylothorax preoperative. 3.The appearment of the preoperative chest X-ray pulmonary atelectasis and pulmonary infection.
4.The lungs leak air appears in the surgery. 5.Patients with severe cardiovascular and cerebrovascular accident after operation were terminated.
6.Impaired lung function (forced expiratory volume in 1 second [FEV1]<60% predicted).

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
avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lungAvoiding chest drainage tube placement after VATS of the lung in the experiment group.	Procedure or surgery	avoiding chest drainage tube placement after resection of lung
Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lungIndewlling chest drainage tube after VATS of lung in the control group.	Procedure or surgery	indewlling chest drainage tube after resection of lung

Primary outcome

operation time
Time frame: 1 day
From the beginnning of ansesthesia to the end of anesthesia
hospitalization expenses
Time frame: 15 days
the total cost of hospitalzation
postoperative complication rate
Time frame: a month
incidence of postoperative complications such as pneumothorax and hydrohorax
duration of postoperation pain
Time frame: 10 days
postoperative pain duration
VAS pain scores
Time frame: 3 days
the VAS pain score was given to patients and the pain scores were recorded at 6h,12h,24h,48h,and 72h postoperatively.The minimum score is 0 and the maximum score is 10.The high values represent a worse outcome.
the time of early ambulation after operation
Time frame: 1 day
the time from the patient's postoperative pushback to the first bedtime
postoperative extubation time
Time frame: 1 day
postoperative extubation time

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Results publication: PubMed 21626321Nakashima S, Watanabe A, Mishina T, Obama T, Mawatari T, Higami T. Feasibility and safety of postoperative management without chest tube placement after thoracoscopic wedge resection of the lung. Surg Today. 2011 Jun;41(6):774-9. doi: 10.1007/s00595-010-4346-5. Epub 2011 May 28.
Results publication: PubMed 27510705Holbek BL, Hansen HJ, Kehlet H, Petersen RH. Thoracoscopic pulmonary wedge resection without post-operative chest drain: an observational study. Gen Thorac Cardiovasc Surg. 2016 Oct;64(10):612-7. doi: 10.1007/s11748-016-0692-6. Epub 2016 Aug 10.
Results publication: PubMed 29997933Li P, Shen C, Wu Y, Lai Y, Zhou K, Che G. It is safe and feasible to omit the chest tube postoperatively for selected patients receiving thoracoscopic pulmonary resection: a meta-analysis. J Thorac Dis. 2018 May;10(5):2712-2721. doi: 10.21037/jtd.2018.04.75.
Results publication: PubMed 27865329Filosso PL, Sandri A, Guerrera F, Roffinella M, Bora G, Solidoro P. Management of Chest Drains After Thoracic Resections. Thorac Surg Clin. 2017 Feb;27(1):7-11. doi: 10.1016/j.thorsurg.2016.08.002.
Results publication: PubMed 9875783Russo L, Wiechmann RJ, Magovern JA, Szydlowski GW, Mack MJ, Naunheim KS, Landreneau RJ. Early chest tube removal after video-assisted thoracoscopic wedge resection of the lung. Ann Thorac Surg. 1998 Nov;66(5):1751-4. doi: 10.1016/s0003-4975(98)00946-1.
Results publication: PubMed 27688029Lu TY, Chen JX, Chen PR, Lin YS, Chen CK, Kao PY, Huang TM, Fang HY. Evaluation of the necessity for chest drain placement following thoracoscopic wedge resection. Surg Today. 2017 May;47(5):606-610. doi: 10.1007/s00595-016-1414-5. Epub 2016 Sep 29.
Results publication: PubMed 15082297Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. doi: 10.1016/j.ejcts.2004.01.041.
Results publication: PubMed 28289835Deng B, Qian K, Zhou JH, Tan QY, Wang RW. Optimization of Chest Tube Management to Expedite Rehabilitation of Lung Cancer Patients After Video-Assisted Thoracic Surgery: A Meta-Analysis and Systematic Review. World J Surg. 2017 Aug;41(8):2039-2045. doi: 10.1007/s00268-017-3975-x.
Results publication: PubMed 29078230Chiappetta M, Lococo F, Nachira D, Ciavarella LP, Congedo MT, Porziella V, Meacci E, Margaritora S. Digital Devices Improve Chest Tube Management: Results from a Prospective Randomized Trial. Thorac Cardiovasc Surg. 2018 Oct;66(7):595-602. doi: 10.1055/s-0037-1607443. Epub 2017 Oct 27.
Individual participant dataSharing planned: Yes. hospital cost and complications of postoperation

Related trials for Lung Diseases

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

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.

Xueying Yang, M.D. contact

86-24-62255001

yangxy@sj-hospital.org

Xueying Yang, M.D. principal investigator

The Fourth Affiliated Hospital of China Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Oct 2019. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xueying Yang, M.D. (86-24-62255001, yangxy@sj-hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

operation time (time frame: 1 day). The study lists 7 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 NCT04012554, which also lists 9 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 8 Oct 2019.