Safety And Recovery Of Tubeless Strategy In Uniportal VATS Wedge Resection

NCT07395349 | Not Yet Recruiting

• 1 other identifier: GYFYY-THOR-TUBELESS-RCT-2026-0
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Pulmonary Nodule; Pneumothorax; Postoperative Complications

Keywords

Uniportal VATS; Wedge Resection; Tubeless; Intraoperative Aspiration; Chest Tube Drainage; Enhanced Recovery After Surgery (ERAS); Lung Re-expansion

Outcome Measures

Primary Outcomes (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.

  From surgery to 30 days postoperatively

Secondary Outcomes (2)

• Lung Re-expansion on Postoperative Day 1 Chest X-ray

  Postoperative day 1

• Postoperative Pain (VAS) Score

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

Study Arms (3)

Conventional Chest Tube Drainage (CTD)

ACTIVE COMPARATOR

Participants 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.

Procedure: Conventional Chest Tube Drainage

Single Intraoperative Aspiration Tubeless (SIA-Tubeless)

EXPERIMENTAL

Participants 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.

Procedure: Single Intraoperative Aspiration Tubeless

Double Intraoperative Aspiration Tubeless (DIA-Tubeless)

EXPERIMENTAL

Participants 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.

Procedure: Double Intraoperative Aspiration Tubeless

Interventions

Double Intraoperative Aspiration Tubeless PROCEDURE

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.

Also known as: DIA-Tubeless

Double Intraoperative Aspiration Tubeless (DIA-Tubeless)

Conventional Chest Tube Drainage PROCEDURE

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.

Also known as: CTD

Conventional Chest Tube Drainage (CTD)

Single Intraoperative Aspiration Tubeless PROCEDURE

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.

Also known as: SIA-Tubeless

Single Intraoperative Aspiration Tubeless (SIA-Tubeless)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of GZMU

Guangzhou, China

Location

Related Publications (4)

• 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.

  PMID: 38092062 RESULT

• 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.

  PMID: 30959014 RESULT

• 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.

  PMID: 30304509 RESULT

• 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.

  PMID: 27865474 RESULT

MeSH Terms

Conditions

Pneumothorax; Postoperative Complications

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yudong Zhang, MD

CONTACT

+86 13168266675; yudongz834@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label surgical trial. Due to the nature of the interventions, masking of participants, care providers, and investigators is not feasible. Outcome assessments are based on objective clinical events and standardized evaluation criteria.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Thoracic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 9, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available after publication of the primary study results, beginning approximately 6 months after publication, and will remain available for up to 5 years.
• Access Criteria: Access to de-identified IPD and supporting information will be granted to qualified researchers upon reasonable request. Requests must include a brief research proposal and analysis plan and be approved by the study investigators. Data will be shared for academic research purposes only, without any attempt to re-identify participants. Data will be provided through secure data transfer methods.

Locations

CN (1)