Thoracic Surgery, Video-AssistedNCT03230019
Two-Lumen Catheterization For Lung Wedge Resection
A study testing chest tube, two-lumen catheterization and two-lumen catheter in people with Thoracic Surgery, Video-Assisted, run by Wen-zhao ZHONG at 1 site in China.
Trial summary
This study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection. Half of participants will receive routine chest tube placement, while the other half will receive a two-lumen central venous catheterization along the midclavicular line, second… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Video-Assisted
- What is being tested?
- chest tube, two-lumen catheterization and two-lumen catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2017to 30 Oct 2019
- 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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 51000
Wen-Zhao Zhong, Ph.D, 13609777314, 13609777314@163.com
Song Dong, Ph.D, 13631381979, dsong@aliyun.com
About this study
Official title: Two-Lumen Catheterization Versus Chest Tube Placement in Patients With Lung Wedge Resection: A Prospective Randomized Trial
This study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection. Half of participants will receive routine chest tube placement, 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 10~40% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization for remedial gas-remove. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection.
- Conditions
- Thoracic Surgery, Video-Assisted
- Being tested
- chest tube, two-lumen catheterization, two-lumen catheter
- Keywords
- wedge resection, tubeless
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest tubeProcedure or surgery
VATS with chest tube placement
two-lumen catheterizationProcedure or surgery
VATS with two-lumen catheterization long the midclavicular line, second intercostal space
two-lumen catheterDevice
central venous catheter(two-lumen 7-Fr-20cm)
| Study group | Role | What they receive |
|---|---|---|
| chest tube | Active comparator | VATS with chest tube placement Receives: Procedure: chest tube |
| two-lumen catheter | Experimental | VATS with two-lumen catheterization Receives: Procedure: two-lumen catheterization; Device: two-lumen catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative adverse event incidence rate
To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) or pleural effusion (>800ml) in both groups.
Measured: 1 months
Length of post-operative hospital stay
To evaluate the length of post-operative hospital stay
Measured: 1 week
Rate of post-operative related complications
To evaluate the rate of post-operative related complications within 7 days of surgery
Measured: 1 week
Secondary outcomes (5)
Postoperative pneumoderm incidence rate
To evaluate the postoperative pneumoderm incidence rate in both groups.
Measured: 3 days
The time of post-operative extubation
To evaluate the time of duration of chest tube or catheterization.
Measured: 1 week
Postoperative pulmonary function recovery
To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.
Measured: 1 week
Postoperative pain score
To evaluate the pain score via NRS pain scale first day after surgery.
Measured: 1 day
Postoperative wound satisfaction
To evaluate the post-operative wound healing condition .
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 posted26 Jul 2017
- Study start25 Aug 2017
- Primary completion1 Oct 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
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 Thoracic Surgery, Video-AssistedStudies 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
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-zhao ZHONG
- Collaborators
- Guangdong Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
- Investigators
- Wen-Zhao Zhong, Ph.D, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230019
- Sponsor's protocol ID
- TBL-1
- Status last verified
- Nov 2018
- First submitted
- 23 Jul 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang SM, Wang ML, Hung MH, Hsu HH, Cheng YJ, Chen JS. Tubeless Uniportal Thoracoscopic Wedge Resection for Peripheral Lung Nodules. Ann Thorac Surg. 2017 Feb;103(2):462-468. doi: 10.1016/j.athoracsur.2016.09.006. Epub 2016 Nov 16.
PubMed 27865474Watanabe 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 15082297Ueda K, Hayashi M, Tanaka T, Hamano K. Omitting chest tube drainage after thoracoscopic major lung resection. Eur J Cardiothorac Surg. 2013 Aug;44(2):225-9; discussion 229. doi: 10.1093/ejcts/ezs679. Epub 2013 Jan 12.
PubMed 23313864Wei S, Zhang G, Ma J, Nong L, Zhang J, Zhong W, Cui J. Randomized controlled trial of an alternative drainage strategy vs routine chest tube insertion for postoperative pain after thoracoscopic wedge resection. BMC Anesthesiol. 2022 Jan 18;22(1):27. doi: 10.1186/s12871-022-01569-w.
PubMed 35042458Zhang JT, Qin H, Man Cheung FK, Su J, Zhang DD, Liu SY, Li XF, Qin J, Lin JT, Jiang BY, Song Dong, Liao RQ, Qiang N, Yang XN, Tu HY, Zhou Q, Yang JJ, Zhang XC, Zhang YN, Wu YL, Zhong WZ. Plasma extracellular vesicle microRNAs for pulmonary ground-glass nodules. J Extracell Vesicles. 2019 Sep 18;8(1):1663666. doi: 10.1080/20013078.2019.1663666. eCollection 2019.
PubMed 31579436
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Lumen Catheterization Versus Chest Tube Placement in Patients With Lung Wedge Resection: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03230019
- Acronym / sponsor ID
- TBL-1
- Conditions
- Thoracic Surgery, Video-Assisted
- Keywords
- wedge resection, tubeless
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Wen-zhao ZHONG
- Collaborators
- Guangdong Provincial People's Hospital
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 26 Jul 2017 (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 chest tube placement in patients with lung wedge resection. Half of participants will receive routine chest tube placement, 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 10~40% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization for remedial gas-remove. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chest tube | Active comparator | Procedure: chest tubeVATS with chest tube placement |
| two-lumen catheter | Experimental | Procedure: two-lumen catheterization, Device: two-lumen catheterVATS with two-lumen catheterization |
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 |
|---|---|---|
| chest tubeVATS with chest tube placement | Procedure or surgery | chest tube |
| two-lumen catheterizationVATS with two-lumen catheterization long the midclavicular line, second intercostal space | Procedure or surgery | two-lumen catheter |
| two-lumen cathetercentral venous catheter(two-lumen 7-Fr-20cm) | Device | two-lumen catheter |
Primary outcome
Postoperative adverse event incidence rate
Time frame: 1 months
To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) or pleural effusion (>800ml) in both groups.
Length of post-operative hospital stay
Time frame: 1 week
To evaluate the length of post-operative hospital stay
Rate of post-operative related complications
Time frame: 1 week
To evaluate the rate of post-operative related complications within 7 days of surgery
5 secondary outcomes
Postoperative pneumoderm incidence rate
Time frame: 3 days
The time of post-operative extubation
Time frame: 1 week
Postoperative pulmonary function recovery
Time frame: 1 week
Postoperative pain score
Time frame: 1 day
Postoperative wound satisfaction
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 14 Nov 2018.
- Background: PubMed 27865474Yang SM, Wang ML, Hung MH, Hsu HH, Cheng YJ, Chen JS. Tubeless Uniportal Thoracoscopic Wedge Resection for Peripheral Lung Nodules. Ann Thorac Surg. 2017 Feb;103(2):462-468. doi: 10.1016/j.athoracsur.2016.09.006. Epub 2016 Nov 16.
- Background: 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.
- Background: PubMed 23313864Ueda K, Hayashi M, Tanaka T, Hamano K. Omitting chest tube drainage after thoracoscopic major lung resection. Eur J Cardiothorac Surg. 2013 Aug;44(2):225-9; discussion 229. doi: 10.1093/ejcts/ezs679. Epub 2013 Jan 12.
- Derived from this study: PubMed 35042458Wei S, Zhang G, Ma J, Nong L, Zhang J, Zhong W, Cui J. Randomized controlled trial of an alternative drainage strategy vs routine chest tube insertion for postoperative pain after thoracoscopic wedge resection. BMC Anesthesiol. 2022 Jan 18;22(1):27. doi: 10.1186/s12871-022-01569-w.
- Derived from this study: PubMed 31579436Zhang JT, Qin H, Man Cheung FK, Su J, Zhang DD, Liu SY, Li XF, Qin J, Lin JT, Jiang BY, Song Dong, Liao RQ, Qiang N, Yang XN, Tu HY, Zhou Q, Yang JJ, Zhang XC, Zhang YN, Wu YL, Zhong WZ. Plasma extracellular vesicle microRNAs for pulmonary ground-glass nodules. J Extracell Vesicles. 2019 Sep 18;8(1):1663666. doi: 10.1080/20013078.2019.1663666. eCollection 2019.
- 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 principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest tube, two-lumen catheterization and two-lumen catheter in people with Thoracic Surgery, Video-Assisted, run by Wen-zhao ZHONG 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 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 14 Nov 2018. 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 Wen-Zhao Zhong (18820792959, 18820792959@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative adverse event incidence rate (time frame: 1 months). The study lists 3 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 NCT03230019, 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 14 Nov 2018.