DrainageNCT04207671
Improved Drainage Strategy for Patients With Lung Wedge Resection
A study testing Complete omission of chest tube and Improved drainage strategy in people with Drainage, run by Guangdong Provincial People's Hospital.
Trial summary
This study evaluates the viability and safety of two-lumen catheterization versus complete omission of chest tube in patients with lung wedge resection. Half of participants will receive complete omission of chest tube, while the other half will receive a two-lumen central venous catheterization along the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drainage
- What is being tested?
- Complete omission of chest tube and Improved drainage strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative radiology revealed solitary peripheral pulmonary nodule, with both size and depth less than 3 cm
- Lung wedge resection for tumor biopsy to elucidate drug resistant mechanism or confirm diagnosis
Who cannot join
- Previous ipsilateral thoracic surgery or extensive adhesion
- Preoperative radiology revealed pneumonia or atelectasis
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Bleeding tendency or anticoagulant use
- Pregnancy or breast feeding
- Patient who can not sign permit
Trial locations and contacts
No sites are listed yet.
Wen-Zhao Zhong, Ph.D contact
About this study
Official title: Omission of Chest Tube Versus Improved Drainage Strategy in Patients With Lung Wedge Resection: A Prospective Randomized Trial
This study evaluates the viability and safety of two-lumen catheterization versus complete omission of chest tube in patients with lung wedge resection. Half of participants will receive complete omission of chest tube, while the other half will receive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove.
Read the detailed description
With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over the last three decades. The concept of "tubeless" involves non-intubated anesthesia with spontaneous ventilation and no chest tube placement. Chest tube placement always causes pain, and its duration is known to be one of the most important factors influencing hospital stay and costs. Early tube removal allows patients to breathe deeply with less pain, which leads to more compliance with chest physiotherapy, as demonstrated by a concomitant improvement in patients' ventilatory function. Hence, more and more experienced surgeons choose the omission of chest tube placement after lung wedge resection. However, based on previous retrospective studies, residual pneumothorax was noted in about 10% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization as improved drainage strategy. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus omission of chest tube placement in patients with lung wedge resection.
- Conditions
- Drainage
- Being tested
- Complete omission of chest tube, Improved drainage strategy
- Keywords
- Tubeless, Wedge resection, Improved drainage strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete omission of chest tubeProcedure or surgery
No chest tube implacement
Improved drainage strategyProcedure or surgery
A two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove
| Study group | Role | What they receive |
|---|---|---|
| Omission of chest tube | Other | After wedge resection and the air-leak test, patients will receive complete omission of chest tube and directly close the incision. Receives: Procedure: Complete omission of chest tube |
| Improved drainage strategy | Experimental | After wedge resection and the air-leak test, patients willreceive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-removal. Receives: Procedure: Improved drainage strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of massive pneumothorax on day 1 after surgery
To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray)
Measured: 1 day
Secondary outcomes (3)
Pain score on day 1 after surgery
To evaluate the pain score via numerical rating scale on day 1 after surgery. An 11-point numeric scale (NRS 11) with 0 representing no pain and 10 representing worst pain imaginable.
Measured: 1 day
Length of post-operative hospital stay
To evaluate the length of post-operative hospital stay.
Measured: 1 week
Postoperative pulmonary function recovery
To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study startMar 2020 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DrainageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
- Investigators
- Song Dong, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207671
- Sponsor's protocol ID
- TBL-2
- Status last verified
- Jan 2020
- First submitted
- 19 Dec 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang JT, Tang YC, Lin JT, Dong S, Nie Q, Jiang BY, Yan HH, Wen ZW, Wu Y, Yang XN, Wu YL, Zhong WZ. Prophylactic air-extraction strategy after thoracoscopic wedge resection. Thorac Cancer. 2018 Nov;9(11):1406-1412. doi: 10.1111/1759-7714.12850. Epub 2018 Sep 6.
PubMed 30187689
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omission of Chest Tube Versus Improved Drainage Strategy in Patients With Lung Wedge Resection: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04207671
- Acronym / sponsor ID
- TBL-2
- Conditions
- Drainage
- Keywords
- Tubeless, Wedge resection, Improved drainage strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 23 Dec 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.
This study evaluates the viability and safety of two-lumen catheterization versus complete omission of chest tube in patients with lung wedge resection. Half of participants will receive complete omission of chest tube, while the other half will receive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove.
Detailed description
With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over the last three decades. The concept of "tubeless" involves non-intubated anesthesia with spontaneous ventilation and no chest tube placement. Chest tube placement always causes pain, and its duration is known to be one of the most important factors influencing hospital stay and costs. Early tube removal allows patients to breathe deeply with less pain, which leads to more compliance with chest physiotherapy, as demonstrated by a concomitant improvement in patients' ventilatory function. Hence, more and more experienced surgeons choose the omission of chest tube placement after lung wedge resection. However, based on previous retrospective studies, residual pneumothorax was noted in about 10% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization as improved drainage strategy. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus omission of chest tube placement in patients with lung wedge resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omission of chest tube | Other | Procedure: Complete omission of chest tubeAfter wedge resection and the air-leak test, patients will receive complete omission of chest tube and directly close the incision. |
| Improved drainage strategy | Experimental | Procedure: Improved drainage strategyAfter wedge resection and the air-leak test, patients willreceive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Preoperative radiology revealed solitary peripheral pulmonary nodule, with both size and depth less than 3 cm
- Lung wedge resection for tumor biopsy to elucidate drug resistant mechanism or confirm diagnosis
Key exclusion criteria (6 listed)
- Previous ipsilateral thoracic surgery or extensive adhesion
- Preoperative radiology revealed pneumonia or atelectasis
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Bleeding tendency or anticoagulant use
- Pregnancy or breast feeding
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 |
|---|---|---|
| Complete omission of chest tubeNo chest tube implacement | Procedure or surgery | Omission of chest tube |
| Improved drainage strategyA two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove | Procedure or surgery | Improved drainage strategy |
Primary outcome
The incidence rate of massive pneumothorax on day 1 after surgery
Time frame: 1 day
To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray)
3 secondary outcomes
Pain score on day 1 after surgery
Time frame: 1 day
Length of post-operative hospital stay
Time frame: 1 week
Postoperative pulmonary function recovery
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 30187689Zhang JT, Tang YC, Lin JT, Dong S, Nie Q, Jiang BY, Yan HH, Wen ZW, Wu Y, Yang XN, Wu YL, Zhong WZ. Prophylactic air-extraction strategy after thoracoscopic wedge resection. Thorac Cancer. 2018 Nov;9(11):1406-1412. doi: 10.1111/1759-7714.12850. Epub 2018 Sep 6.
- Individual participant dataSharing planned: No
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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.
Wen-Zhao Zhong, Ph.D contact
Song Dong principal investigator
Guangdong Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Complete omission of chest tube and Improved drainage strategy in people with Drainage, run by Guangdong Provincial People's Hospital.
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 6 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jia-Tao Zhang, Ph.D (+86-83827812-51311, 18820792959@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of massive pneumothorax on day 1 after surgery (time frame: 1 day). 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 NCT04207671, which also lists 1 linked publication.
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 Jan 2020.