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Pulmonary NoduleNCT07395349

Safety And Recovery Of Tubeless Strategy In Uniportal VATS Wedge Resection

A study testing Conventional Chest Tube Drainage, Single Intraoperative Aspiration Tubeless and Double Intraoperative Aspiration Tubeless in people with Pulmonary Nodule and Pneumothorax, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Brief Summary The goal of this clinical trial is to evaluate the safety and recovery outcomes of different tubeless strategies in adult patients undergoing uniportal video-assisted thoracoscopic (VATS) wedge resection who are confirmed to have no persistent air leak intraoperatively. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Conventional Chest Tube Drainage, Single Intraoperative Aspiration Tubeless and Double Intraoperative Aspiration Tubeless
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
28 Feb 2026to 1 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80 years
  • Scheduled to undergo uniportal video-assisted thoracoscopic (VATS) wedge resection
  • Able to tolerate general anesthesia and single-lung ventilation
  • Passed a standardized intraoperative water-seal air leak test, confirming absence of persistent air leak before chest closure
  • Able and willing to provide written informed consent
  • Able to complete postoperative assessments and 30-day follow-up

Who cannot join

  • Planned anatomical lung resection (segmentectomy or lobectomy) or combined complex thoracic procedures
  • Extensive pleural adhesions, severe emphysema, bullous lung disease, or other conditions associated with high risk of air leak
  • Positive intraoperative air leak test indicating persistent air leak
  • Requirement for additional intraoperative procedures that may significantly affect pleural air leak or lung re-expansion
  • Conversion to multiport VATS or thoracotomy before randomization
  • Severe comorbidities or other conditions deemed by the investigators to make participation inappropriate
  • Inability to complete follow-up or insufficient clinical data

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yudong Zhang, MD contact

+86 13168266675

yudongz834@gmail.com

China1 site
  • The First Affiliated Hospital of GZMU

    Guangzhou

    Yudong Zhang, +86 13168266675, yudongz834@gmail.com

Other trials in China

About this study

Official title: Safety And Recovery Of Tubeless Strategy In Uniportal VATS Wedge Resection: A Single-Center, Prospective Randomized Controlled Study Based On Different Intraoperative Pleural Space Management Strategies

Brief Summary

The goal of this clinical trial is to evaluate the safety and recovery outcomes of different tubeless strategies in adult patients undergoing uniportal video-assisted thoracoscopic (VATS) wedge resection who are confirmed to have no persistent air leak intraoperatively.

Read more

The main questions it aims to answer are:

Does double intraoperative aspiration tubeless strategy reduce the rate of postoperative pleural re-intervention within 30 days compared with single intraoperative aspiration tubeless strategy?

Do different intraoperative pleural space management strategies affect early postoperative recovery quality and pain?

If there is a comparison group:

Researchers will compare conventional chest tube drainage, single intraoperative aspiration tubeless, and double intraoperative aspiration tubeless strategies to determine their effects on postoperative pleural re-intervention and recovery outcomes.

Participants will:

Undergo uniportal VATS wedge resection

Receive a standardized intraoperative air leak test before chest closure

Be randomly assigned intraoperatively to one of three pleural space management strategies

Complete postoperative assessments including chest imaging, pain evaluation, and recovery quality questionnaires

Be followed for 30 days after surgery for safety outcomes

Read the detailed description

Uniportal video-assisted thoracoscopic (VATS) wedge resection is widely used for the diagnosis and treatment of peripheral pulmonary nodules. Conventional postoperative chest tube drainage is routinely applied to prevent pneumothorax, but it is associated with increased postoperative pain, delayed mobilization, and prolonged hospital stay. In recent years, tubeless strategies have been introduced in carefully selected patients to enhance recovery; however, postoperative residual pneumothorax and pleural re-intervention remain major safety concerns.

Previous retrospective studies suggest that intraoperative aspiration may improve the feasibility of tubeless VATS, but single aspiration may not completely prevent re-entry of air into the pleural space. A modified strategy using double intraoperative aspiration performed entirely before chest closure may enhance lung re-expansion and reduce postoperative pleural complications. To date, no prospective randomized controlled trial has directly compared different intraoperative aspiration-based tubeless strategies.

This study is a single-center, prospective, three-arm randomized controlled trial conducted at Guangzhou Medical University First Affiliated Hospital. Adult patients undergoing uniportal VATS wedge resection who pass a standardized intraoperative water-seal air leak test will be randomized in a 1:1:1 ratio to one of the following groups:

conventional chest tube drainage,

single intraoperative aspiration tubeless, or

double intraoperative aspiration tubeless.

All aspiration procedures are completed intraoperatively, and no postoperative aspiration or intermittent drainage is permitted in tubeless groups. Perioperative management is standardized across all groups.

The primary outcome is the incidence of pleural re-intervention (thoracentesis or chest tube insertion) within 30 days after surgery. Secondary outcomes include postoperative recovery quality assessed by the QoR-15 questionnaire, postoperative pain assessed by visual analog scale (VAS), lung re-expansion on postoperative day 1 imaging, length of hospital stay, and postoperative pulmonary complications.

This trial aims to provide high-quality evidence to determine whether optimization of intraoperative pleural space management can improve the safety and reliability of tubeless uniportal VATS wedge resection while preserving enhanced recovery benefits.

Being tested
Conventional Chest Tube Drainage, Single Intraoperative Aspiration Tubeless, Double Intraoperative Aspiration Tubeless
Keywords
Uniportal VATS, Wedge Resection, Tubeless, Intraoperative Aspiration, Chest Tube Drainage, Enhanced Recovery After Surgery (ERAS), Lung Re-expansion
Medical subject headings
Pneumothorax, Postoperative Complications

What participants receive

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

  • Conventional Chest Tube DrainageProcedure or surgery

    Also called CTD

    After uniportal VATS wedge resection, a chest tube is routinely placed at the end of surgery for postoperative pleural drainage. Chest tube management, including water seal or suction, criteria for tube removal, and discharge standards, follows standard institutional protocols.

  • Single Intraoperative Aspiration TubelessProcedure or surgery

    Also called SIA-Tubeless

    After uniportal VATS wedge resection and confirmation of no persistent air leak using a standardized intraoperative water-seal air leak test, a single negative-pressure aspiration of the pleural space is performed intraoperatively under positive-pressure ventilation before chest closure. The aspiration catheter is completely removed intraoperatively, and no postoperative chest tube or aspiration is allowed.

  • Double Intraoperative Aspiration TubelessProcedure or surgery

    Also called DIA-Tubeless

    After uniportal VATS wedge resection and confirmation of no persistent air leak using a standardized intraoperative water-seal air leak test, two consecutive negative-pressure aspirations of the pleural space are performed intraoperatively under positive-pressure ventilation before chest closure. After the second aspiration, the catheter is completely removed. No postoperative chest tube or aspiration is permitted.

Study groups in NCT07395349
Study groupRoleWhat they receive
Conventional Chest Tube Drainage (CTD)Active comparatorParticipants undergo uniportal VATS wedge resection followed by routine postoperative chest tube drainage. A chest tube is placed at the end of surgery and managed according to standard institutional protocols, including water seal or suction, criteria for tube removal, and discharge standards. This arm serves as the control group for comparison with tubeless strategies.
Receives: Procedure: Conventional Chest Tube Drainage
Single Intraoperative Aspiration Tubeless (SIA-Tubeless)ExperimentalParticipants undergo uniportal VATS wedge resection and, after passing a standardized intraoperative water-seal air leak test, receive a single intraoperative negative-pressure aspiration of the pleural space under positive-pressure ventilation before chest closure. The catheter is completely removed intraoperatively, and no postoperative chest tube or aspiration is permitted.
Receives: Procedure: Single Intraoperative Aspiration Tubeless
Double Intraoperative Aspiration Tubeless (DIA-Tubeless)ExperimentalParticipants undergo uniportal VATS wedge resection and, after passing a standardized intraoperative water-seal air leak test, receive two consecutive intraoperative negative-pressure aspirations of the pleural space under positive-pressure ventilation before chest closure. After the second aspiration, the catheter is completely removed. No postoperative chest tube or aspiration is permitted.
Receives: Procedure: Double Intraoperative Aspiration Tubeless

What is being measured

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

  1. Pleural Re-intervention Within 30 Days

    Incidence of pleural re-intervention within 30 days after surgery, defined as thoracentesis or chest tube insertion performed for postoperative pneumothorax or residual intrapleural air.

    Measured: From surgery to 30 days postoperatively

Secondary outcomes (2)
  1. Lung Re-expansion on Postoperative Day 1 Chest X-ray

    Residual pneumothorax / lung re-expansion status assessed on postoperative day 1 chest X-ray using a predefined grading or qualitative evaluation.

    Measured: Postoperative day 1

  2. Postoperative Pain (VAS) Score

    Pain intensity assessed using a Visual Analog Scale (VAS), range 0-10, where higher scores indicate more severe pain.

    Measured: Postoperative day 1 and at hospital discharge, assessed up to 30 days after surgery

Timeline

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

  1. First posted9 Feb 2026
  2. Study start28 Feb 2026 (estimated)
  3. Primary completion28 Aug 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

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
Participants who meet intraoperative eligibility criteria are randomized in a 1:1:1 ratio to three parallel groups receiving different intraoperative pleural space management strategies.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07395349
Sponsor's protocol ID
GYFYY-THOR-TUBELESS-RCT-2026-0
Status last verified
Feb 2026
First submitted
25 Jan 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcome results, including baseline characteristics, intervention assignment, and outcome measures, will be shared.

Publications

  • Yang Q, Lv S, Li Q, Lan L, Sun X, Feng X, Han K. Safety and feasibility study of uniportal video-assisted thoracoscopic pulmonary wedge resection without postoperative chest tube drainage: a retrospective propensity score-matched study. Interdiscip Cardiovasc Thorac Surg. 2022 Jan 1;37(6):ivad196. doi: 10.1093/icvts/ivad196.

    PubMed 38092062
  • Ueda K, Haruki T, Murakami J, Tanaka T, Hayashi M, Hamano K. No Drain After Thoracoscopic Major Lung Resection for Cancer Helps Preserve the Physical Function. Ann Thorac Surg. 2019 Aug;108(2):399-404. doi: 10.1016/j.athoracsur.2019.03.018. Epub 2019 Apr 5.

    PubMed 30959014
  • Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.

    PubMed 30304509
  • 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 27865474

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Chest Tube Drainage, Single Intraoperative Aspiration Tubeless and Double Intraoperative Aspiration Tubeless in people with Pulmonary Nodule and Pneumothorax, run by The First Affiliated Hospital of Guangzhou Medical University 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yudong Zhang, MD (+86 13168266675, yudongz834@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pleural Re-intervention Within 30 Days (time frame: From surgery to 30 days postoperatively). 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 NCT07395349, which also lists 4 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 9 Feb 2026.

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