Pulmonary NodulesNCT07409129
Tubeless Strategy for Enhanced Recovery After Sublobar Resection
A study testing Laryngeal Mask Airway, Thoracic Paravertebral Block with Local Anesthetic and Non-intubated Anesthesia in people with Pulmonary Nodules and Early Stage Lung Cancer (I and II), run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This is a prospective, randomized controlled clinical trial conducted at a single center. The study aims to evaluate whether a "tubeless" strategy can enhance recovery for patients undergoing minimally invasive thoracoscopic sublobar resection (wedge or segment resection) for small lung nodules. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Nodules, Early Stage Lung Cancer (I and II), Thoracoscopic Surgery
- What is being tested?
- Laryngeal Mask Airway, Thoracic Paravertebral Block with Local Anesthetic and Non-intubated Anesthesia
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Scheduled for uniportal or multiportal video-assisted thoracoscopic surgery (VATS) for sublobar resection (wedge or segmentectomy).
- Presence of peripheral lung nodules ≤ 2 cm in diameter and ≤ 2 cm from the pleura, confirmed by CT scan.
- Ability to understand and provide written informed consent.
- American Society of Anesthesiologists (ASA) physical status I-III.
Who cannot join
- Severe pleural adhesions or fibrosis that would preclude non-intubated anesthesia or tubeless approach.
- Severe cardiopulmonary dysfunction: FEV1 < 50% predicted, DLCO < 60% predicted, heart failure (NYHA class III-IV), or unstable angina.
- Pregnancy or lactation (confirmed by urine test if applicable).
- Inability to tolerate one-lung ventilation due to anatomical or physiological reasons.
- History of ipsilateral thoracic surgery.
- Active pulmonary infection, uncontrolled diabetes, or other comorbidities that increase surgical risk.
- Participation in another interventional trial within 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of GZMU
Guangzhou, China, 510120
hengrui liang, 86+020-83062807, liang_hengrui@163.com
liang, liang_hengrui@163.com
About this study
Official title: Tubeless Strategy Within an Enhanced Recovery After Surgery (ERAS) Protocol for Thoracoscopic Sublobar Resection: A Randomized Controlled Trial
This is a prospective, randomized controlled clinical trial conducted at a single center. The study aims to evaluate whether a "tubeless" strategy can enhance recovery for patients undergoing minimally invasive thoracoscopic sublobar resection (wedge or segment resection) for small lung nodules.
Participants will be randomly assigned to one of two groups:
Read more
- The experimental group will receive the "tubeless" strategy, which includes non-endotracheal intubation anesthesia (using a laryngeal mask) and no routine chest tube drainage after surgery.
- The control group will receive the traditional strategy, which includes double-lumen endotracheal intubation anesthesia and routine chest tube drainage.
The main goal is to compare the rate of achieving high-quality fast-track recovery at 24 hours after surgery between the two groups. This study will provide evidence on whether the tubeless approach can help patients recover faster and more comfortably without compromising safety.
Read the detailed description
This is a prospective, open-label, randomized controlled trial with a 1:1 allocation ratio. Adult patients (aged 18-75) scheduled for uniportal VATS sublobar resection for peripheral lung nodules (≤2 cm, ≤2 cm from the pleura) will be assessed for eligibility. Key exclusion criteria include severe pleural adhesions, inability to achieve selective lung ventilation, and severe cardiopulmonary dysfunction.
The primary outcome is a composite endpoint measuring the rate of high-quality fast-track recovery at 24 hours postoperatively, defined as simultaneously meeting all three criteria: 1) meeting standardized discharge criteria, 2) a QoR-15 (Quality of Recovery-15) score ≥130, and 3) absence of Clavien-Dindo grade ≥II respiratory adverse events until the first follow-up.
Secondary outcomes include individual components of the primary endpoint, pneumothorax rate, postoperative pain scores, time to first ambulation, length of hospital stay, hospitalization costs, and patient satisfaction. A sample size of 138 participants (69 per group) was calculated to provide sufficient statistical power. Data analysis will follow the intention-to-treat principle.
- Conditions
- Pulmonary Nodules, Early Stage Lung Cancer (I and II), Thoracoscopic Surgery, Sublobar Resection
- Being tested
- Laryngeal Mask Airway, Thoracic Paravertebral Block with Local Anesthetic, Non-intubated Anesthesia, Double-lumen Endotracheal Tube, Chest Tube Drainage
- Keywords
- Tubeless Surgery, Non-intubated Anesthesia, Enhanced Recovery After Surgery, Sublobar resection, Wedge Resection, Segmentectomy
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask AirwayDevice
Airway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery.
Thoracic Paravertebral Block with Local AnestheticDrug
Thoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia.
Non-intubated AnesthesiaProcedure or surgery
General anesthesia with spontaneous ventilation without endotracheal intubation.
Double-lumen Endotracheal TubeDevice
Double-lumen endotracheal intubation for one-lung ventilation under general anesthesia.
Chest Tube DrainageDevice
Routine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Tubeless Strategy Group | Experimental | Participants in this arm receive the tubeless strategy:
* Anesthesia: Laryngeal mask airway with spontaneous ventilation (non-intubated).
* Drainage: No chest tube placement after surgery
* Goal: To enhance recovery by minimizing invasive procedures. Receives: Device: Laryngeal Mask Airway; Drug: Thoracic Paravertebral Block with Local Anesthetic; Procedure: Non-intubated Anesthesia |
| Traditional Strategy Group | Active comparator | Participants in this arm receive the conventional standard care:
* Anesthesia: Double-lumen endotracheal intubation with mechanical ventilation.
* Drainage: Routine chest tube drainage with water-seal suction postoperatively.
* Follows current clinical guidelines for thoracoscopic sublobar resection. Receives: Device: Double-lumen Endotracheal Tube; Device: Chest Tube Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour high-quality recovery rate
Composite endpoint defined as meeting all of the following criteria at 24 hours postoperatively: (1) meeting standardized discharge criteria (stable vital signs, controlled pain, autonomous ambulation); (2) Quality of Recovery-15 (QoR-15) score ≥130 (range 0-150; higher scores indicate better recovery); and (3) absence of Clavien-Dindo grade ≥II respiratory complications.
Measured: 24 hours after surgery
Secondary outcomes (1)
Postoperative complications (Clavien-Dindo classification)
Incidence and severity of postoperative complications classified according to the Clavien-Dindo classification, including pneumothorax, atelectasis, and pleural effusion requiring intervention.
Measured: From surgery until 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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 prospective, randomized, open-label, parallel-group, single-center trial with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409129
- Sponsor's protocol ID
- TL-ERAS-SLR
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data that underlie the results reported in the primary publication of this trial will be shared. This includes baseline characteristics (age, gender, BMI), intraoperative data (operation time, blood loss), and primary and secondary outcome data (e.g., QoR-15 scores, pneumothorax rates, length of stay, complication rates).
Publications
Wen Y, Liang H, Qiu G, Liu Z, Liu J, Ying W, Liang W, He J. Non-intubated spontaneous ventilation in video-assisted thoracoscopic surgery: a meta-analysis. Eur J Cardiothorac Surg. 2020 Mar 1;57(3):428-437. doi: 10.1093/ejcts/ezz279.
PubMed 31725158Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
PubMed 35430086Liu J, Liang H, Cui F, Liu H, Zhu C, Liang W, He J; International Tubeless-Video-Assisted Thoracoscopic Surgery Collaboration. Spontaneous versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: A randomized trial. J Thorac Cardiovasc Surg. 2022 May;163(5):1702-1714.e7. doi: 10.1016/j.jtcvs.2021.01.093. Epub 2021 Feb 3.
PubMed 33785209Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.
PubMed 21869676Batchelor 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 30304509Khoury AL, McGinigle KL, Freeman NL, El-Zaatari H, Feltner C, Long JM; University of North Carolina School of Medicine Enhanced Recovery Program Working Group. Enhanced recovery after thoracic surgery: Systematic review and meta-analysis. JTCVS Open. 2021 Jul 15;7:370-391. doi: 10.1016/j.xjon.2021.07.007. eCollection 2021 Sep.
PubMed 36003715Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6.
PubMed 7891489
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tubeless Strategy Within an Enhanced Recovery After Surgery (ERAS) Protocol for Thoracoscopic Sublobar Resection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07409129
- Acronym / sponsor ID
- TL-ERAS-SLR
- Conditions
- Pulmonary Nodules, Early Stage Lung Cancer (I and II), Thoracoscopic Surgery, Sublobar Resection
- Keywords
- Tubeless Surgery, Non-intubated Anesthesia, Enhanced Recovery After Surgery, Sublobar resection, Wedge Resection, Segmentectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Feb 2026 (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 is a prospective, randomized controlled clinical trial conducted at a single center. The study aims to evaluate whether a "tubeless" strategy can enhance recovery for patients undergoing minimally invasive thoracoscopic sublobar resection (wedge or segment resection) for small lung nodules.
Participants will be randomly assigned to one of two groups:
- The experimental group will receive the "tubeless" strategy, which includes non-endotracheal intubation anesthesia (using a laryngeal mask) and no routine chest tube drainage after surgery.
- The control group will receive the traditional strategy, which includes double-lumen endotracheal intubation anesthesia and routine chest tube drainage.
The main goal is to compare the rate of achieving high-quality fast-track recovery at 24 hours after surgery between the two groups. This study will provide evidence on whether the tubeless approach can help patients recover faster and more comfortably without compromising safety.
Detailed description
This is a prospective, open-label, randomized controlled trial with a 1:1 allocation ratio. Adult patients (aged 18-75) scheduled for uniportal VATS sublobar resection for peripheral lung nodules (≤2 cm, ≤2 cm from the pleura) will be assessed for eligibility. Key exclusion criteria include severe pleural adhesions, inability to achieve selective lung ventilation, and severe cardiopulmonary dysfunction.
The primary outcome is a composite endpoint measuring the rate of high-quality fast-track recovery at 24 hours postoperatively, defined as simultaneously meeting all three criteria: 1) meeting standardized discharge criteria, 2) a QoR-15 (Quality of Recovery-15) score ≥130, and 3) absence of Clavien-Dindo grade ≥II respiratory adverse events until the first follow-up.
Secondary outcomes include individual components of the primary endpoint, pneumothorax rate, postoperative pain scores, time to first ambulation, length of hospital stay, hospitalization costs, and patient satisfaction. A sample size of 138 participants (69 per group) was calculated to provide sufficient statistical power. Data analysis will follow the intention-to-treat principle.
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 prospective, randomized, open-label, parallel-group, single-center trial with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Tubeless Strategy Group | Experimental | Device: Laryngeal Mask Airway, Drug: Thoracic Paravertebral Block with Local Anesthetic, Procedure: Non-intubated AnesthesiaParticipants in this arm receive the tubeless strategy: * Anesthesia: Laryngeal mask airway with spontaneous ventilation (non-intubated). * Drainage: No chest tube placement after surgery * Goal: To enhance recovery by minimizing invasive procedures. |
| Traditional Strategy Group | Active comparator | Device: Double-lumen Endotracheal Tube, Device: Chest Tube DrainageParticipants in this arm receive the conventional standard care: * Anesthesia: Double-lumen endotracheal intubation with mechanical ventilation. * Drainage: Routine chest tube drainage with water-seal suction postoperatively. * Follows current clinical guidelines for thoracoscopic sublobar resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years.
- Scheduled for uniportal or multiportal video-assisted thoracoscopic surgery (VATS) for sublobar resection (wedge or segmentectomy).
- Presence of peripheral lung nodules ≤ 2 cm in diameter and ≤ 2 cm from the pleura, confirmed by CT scan.
- Ability to understand and provide written informed consent.
- American Society of Anesthesiologists (ASA) physical status I-III.
Key exclusion criteria (7 listed)
- Severe pleural adhesions or fibrosis that would preclude non-intubated anesthesia or tubeless approach.
- Severe cardiopulmonary dysfunction: FEV1 < 50% predicted, DLCO < 60% predicted, heart failure (NYHA class III-IV), or unstable angina.
- Pregnancy or lactation (confirmed by urine test if applicable).
- Inability to tolerate one-lung ventilation due to anatomical or physiological reasons.
- History of ipsilateral thoracic surgery.
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 |
|---|---|---|
| Laryngeal Mask AirwayAirway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery. | Device | Tubeless Strategy Group |
| Thoracic Paravertebral Block with Local AnestheticThoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia. | Drug | Tubeless Strategy Group |
| Non-intubated AnesthesiaGeneral anesthesia with spontaneous ventilation without endotracheal intubation. | Procedure or surgery | Tubeless Strategy Group |
| Double-lumen Endotracheal TubeDouble-lumen endotracheal intubation for one-lung ventilation under general anesthesia. | Device | Traditional Strategy Group |
| Chest Tube DrainageRoutine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively. | Device | Traditional Strategy Group |
Primary outcome
24-hour high-quality recovery rate
Time frame: 24 hours after surgery
Composite endpoint defined as meeting all of the following criteria at 24 hours postoperatively: (1) meeting standardized discharge criteria (stable vital signs, controlled pain, autonomous ambulation); (2) Quality of Recovery-15 (QoR-15) score ≥130 (range 0-150; higher scores indicate better recovery); and (3) absence of Clavien-Dindo grade ≥II respiratory complications.
1 secondary outcome
Postoperative complications (Clavien-Dindo classification)
Time frame: From surgery until 30 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Results publication: PubMed 31725158Wen Y, Liang H, Qiu G, Liu Z, Liu J, Ying W, Liang W, He J. Non-intubated spontaneous ventilation in video-assisted thoracoscopic surgery: a meta-analysis. Eur J Cardiothorac Surg. 2020 Mar 1;57(3):428-437. doi: 10.1093/ejcts/ezz279.
- Results publication: PubMed 35430086Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
- Results publication: PubMed 33785209Liu J, Liang H, Cui F, Liu H, Zhu C, Liang W, He J; International Tubeless-Video-Assisted Thoracoscopic Surgery Collaboration. Spontaneous versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: A randomized trial. J Thorac Cardiovasc Surg. 2022 May;163(5):1702-1714.e7. doi: 10.1016/j.jtcvs.2021.01.093. Epub 2021 Feb 3.
- Results publication: PubMed 21869676Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.
- Results publication: PubMed 30304509Batchelor 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.
- Results publication: PubMed 36003715Khoury AL, McGinigle KL, Freeman NL, El-Zaatari H, Feltner C, Long JM; University of North Carolina School of Medicine Enhanced Recovery Program Working Group. Enhanced recovery after thoracic surgery: Systematic review and meta-analysis. JTCVS Open. 2021 Jul 15;7:370-391. doi: 10.1016/j.xjon.2021.07.007. eCollection 2021 Sep.
- Results publication: PubMed 7891489Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data that underlie the results reported in the primary publication of this trial will be shared. This includes baseline characteristics (age, gender, BMI), intraoperative data (operation time, blood loss), and primary and secondary outcome data (e.g., QoR-15 scores, pneumothorax rates, length of stay, complication rates).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Mask Airway, Thoracic Paravertebral Block with Local Anesthetic and Non-intubated Anesthesia in people with Pulmonary Nodules and Early Stage Lung Cancer (I and II), 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 5 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 13 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 Jianxing He, Ph.D (86+020-83062807, drjianxing.he@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour high-quality recovery rate (time frame: 24 hours after surgery). 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 NCT07409129, which also lists 7 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 13 Feb 2026.