Non-Small Cell Lung CancerDRAIN2024NCT07827885
20-Fr Versus 24-Fr Chest Drains After Uniportal VATS Lobectomy for NSCLC
A study testing 20-Fr Thoracic Drain and 24-Fr Thoracic Drain in people with Non-Small Cell Lung Cancer, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial summary
This randomized clinical trial compared two different chest drain sizes, 20 Fr and 24 Fr, in patients undergoing lung lobectomy for lung cancer. The study aimed to determine whether the size of the chest drain affects postoperative recovery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- 20-Fr Thoracic Drain and 24-Fr Thoracic Drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jul 2025to 28 Feb 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing pulmonary lobectomy with systematic mediastinal lymphadenectomy for lung cancer using a uniportal video-assisted thoracoscopic approach.
- FEV1/FVC >70%.
- Clinical stage up to and including stage IIB according to the eighth or ninth edition of the TNM classification.
- No morphological evidence of macrobullous emphysema on computed tomography.
Who cannot join
- Neoadjuvant chemoradiotherapy.
- Previous ipsilateral pulmonary resection.
- FEV1/FVC <70%.
- Clinical stage beyond IIB according to the eighth or ninth edition of the TNM classification.
- Macrobullous emphysema on computed tomography.
- pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, 00142
About this study
Official title: Prospective Randomized Comparative Evaluation of Different Chest Drainage Devices in Patients Undergoing Lung Lobectomy
This randomized clinical trial compared two different chest drain sizes, 20 Fr and 24 Fr, in patients undergoing lung lobectomy for lung cancer. The study aimed to determine whether the size of the chest drain affects postoperative recovery. Outcomes included the presence of pneumothorax and pleural effusion, postoperative pain, subcutaneous emphysema, prolonged air leak, duration of chest drainage, and length of hospital stay. A total of 80 patients were randomly assigned in a 1:1 ratio to receive either a 20-Fr or a 24-Fr chest drain.
Read the detailed description
Chest drainage is routinely used after pulmonary lobectomy to evacuate air and fluid from the pleural cavity and promote lung re-expansion. However, the optimal chest drain size after minimally invasive lung surgery remains uncertain. Smaller chest drains may improve patient comfort and reduce postoperative pain, but their ability to provide adequate pleural drainage compared with larger drains requires evaluation.
This single-center, prospective, randomized interventional study compared 20-Fr and 24-Fr chest drains in patients undergoing uniportal video-assisted thoracoscopic (uVATS) lung lobectomy with systematic mediastinal lymphadenectomy for non-small cell lung cancer (NSCLC). Eligible patients were randomly assigned in a 1:1 ratio to receive either a 20-Fr or a 24-Fr thoracic drain at the end of surgery.
Postoperative assessment included radiographic evaluation for pneumothorax and residual pleural effusion, as well as evaluation of subcutaneous emphysema, prolonged air leak, analgesic use, postoperative pain using the Numerical Rating Scale, chest drain duration, and length of hospital stay. The study was designed to evaluate whether chest drain size influences postoperative clinical outcomes and patient comfort following minimally invasive pulmonary lobectomy.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- 20-Fr Thoracic Drain, 24-Fr Thoracic Drain
- Keywords
- chest drain, chest tube, thoracic drainage, drain size, uniportal VATS, video-assisted thoracoscopic surgery, lung lobectomy, lung cancer, postoperative pain, thoracic surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-Fr Thoracic DrainDevice
A 20-Fr thoracic drain was placed at the end of video-assisted thoracoscopic lobectomy. The device was used for postoperative pleural and air evacuation.
24-Fr Thoracic DrainDevice
A 24-Fr thoracic drain was placed at the end of video-assisted thoracoscopic lobectomy. The device was used for postoperative pleural and air evacuation.
| Study group | Role | What they receive |
|---|---|---|
| 20-Fr Chest Drain | Experimental | Patients undergoing uniportal video-assisted thoracoscopic lobectomy with systematic mediastinal lymphadenectomy received a 20-Fr thoracic drain at the end of surgery. Receives: Device: 20-Fr Thoracic Drain |
| 24-Fr Chest Drain | Active comparator | Patients undergoing uniportal video-assisted thoracoscopic lobectomy with systematic mediastinal lymphadenectomy received a 24-Fr thoracic drain at the end of surgery. Receives: Device: 24-Fr Thoracic Drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pneumothorax (PNX)
Presence of postoperative PNX assessed by chest X-Ray.
Measured: Immediate postoperative period (POD0), postoperative day 1 (POD1), and postoperative day 3 (POD3)
Postoperative Pleural Effusion
Presence of residual postoperative pleural effusion assessed by chest X-Ray
Measured: Immediate postoperative period (POD0), postoperative day 1 (POD1), and postoperative day 3 (POD3)
Secondary outcomes (6)
Postoperative Subcutaneous Emphysema
Presence of subcutaneous emphysema during the postoperative course.
Measured: During postoperative hospitalization
Postoperative Analgesic Use
Use of analgesic medications during postoperative recovery.
Measured: Immediately after surgery to hospital discharge
Prolonged Air Leak
Presence of postoperative air leak
Measured: From surgery through chest drain removal, with prolonged air leak defined as lasting more than 5 postoperative days, assessed up to 30 days after surgery
Chest Drain Duration
Number of days from surgery to chest drain removal
Measured: Immediately after surgery to chest drain removal, assessed up to 30 days after surgery
Length of Hospital Stay
Number of days from surgery to hospital discharge
Measured: Immediate after surgery to hospital discharge, assessed up to 30 days after surgery
Postoperative Pain
Postoperative pain intensity assessed using the 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain)
Measured: 12, 24, and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start24 Jul 2025
- Primary completion31 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to receive either a 20-Fr or a 24-Fr chest drain after uniportal video-assisted thoracoscopic lobectomy.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierfilippo Crucitti, MD Prof., Principal investigator, Department of Thoracic Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827885
- Sponsor's protocol ID
- 163.25 CET2 cbm
- Acronym
- DRAIN2024
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparative Evaluation of Different Chest Drainage Devices in Patients Undergoing Lung Lobectomy
- ClinicalTrials.gov ID
- NCT07827885
- Acronym / sponsor ID
- DRAIN2024 / 163.25 CET2 cbm
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- chest drain, chest tube, thoracic drainage, drain size, uniportal VATS, video-assisted thoracoscopic surgery, lung lobectomy, lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 18 Sep 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 randomized clinical trial compared two different chest drain sizes, 20 Fr and 24 Fr, in patients undergoing lung lobectomy for lung cancer. The study aimed to determine whether the size of the chest drain affects postoperative recovery. Outcomes included the presence of pneumothorax and pleural effusion, postoperative pain, subcutaneous emphysema, prolonged air leak, duration of chest drainage, and length of hospital stay. A total of 80 patients were randomly assigned in a 1:1 ratio to receive either a 20-Fr or a 24-Fr chest drain.
Detailed description
Chest drainage is routinely used after pulmonary lobectomy to evacuate air and fluid from the pleural cavity and promote lung re-expansion. However, the optimal chest drain size after minimally invasive lung surgery remains uncertain. Smaller chest drains may improve patient comfort and reduce postoperative pain, but their ability to provide adequate pleural drainage compared with larger drains requires evaluation.
This single-center, prospective, randomized interventional study compared 20-Fr and 24-Fr chest drains in patients undergoing uniportal video-assisted thoracoscopic (uVATS) lung lobectomy with systematic mediastinal lymphadenectomy for non-small cell lung cancer (NSCLC). Eligible patients were randomly assigned in a 1:1 ratio to receive either a 20-Fr or a 24-Fr thoracic drain at the end of surgery.
Postoperative assessment included radiographic evaluation for pneumothorax and residual pleural effusion, as well as evaluation of subcutaneous emphysema, prolonged air leak, analgesic use, postoperative pain using the Numerical Rating Scale, chest drain duration, and length of hospital stay. The study was designed to evaluate whether chest drain size influences postoperative clinical outcomes and patient comfort following minimally invasive pulmonary lobectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to receive either a 20-Fr or a 24-Fr chest drain after uniportal video-assisted thoracoscopic lobectomy.
| Arm | Type | Receives |
|---|---|---|
| 20-Fr Chest Drain | Experimental | Device: 20-Fr Thoracic DrainPatients undergoing uniportal video-assisted thoracoscopic lobectomy with systematic mediastinal lymphadenectomy received a 20-Fr thoracic drain at the end of surgery. |
| 24-Fr Chest Drain | Active comparator | Device: 24-Fr Thoracic DrainPatients undergoing uniportal video-assisted thoracoscopic lobectomy with systematic mediastinal lymphadenectomy received a 24-Fr thoracic drain at the end of surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing pulmonary lobectomy with systematic mediastinal lymphadenectomy for lung cancer using a uniportal video-assisted thoracoscopic approach.
- FEV1/FVC >70%.
- Clinical stage up to and including stage IIB according to the eighth or ninth edition of the TNM classification.
- No morphological evidence of macrobullous emphysema on computed tomography.
Key exclusion criteria (6 listed)
- Neoadjuvant chemoradiotherapy.
- Previous ipsilateral pulmonary resection.
- FEV1/FVC <70%.
- Clinical stage beyond IIB according to the eighth or ninth edition of the TNM classification.
- Macrobullous emphysema on computed tomography.
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 |
|---|---|---|
| 20-Fr Thoracic DrainA 20-Fr thoracic drain was placed at the end of video-assisted thoracoscopic lobectomy. The device was used for postoperative pleural and air evacuation. | Device | 20-Fr Chest Drain |
| 24-Fr Thoracic DrainA 24-Fr thoracic drain was placed at the end of video-assisted thoracoscopic lobectomy. The device was used for postoperative pleural and air evacuation. | Device | 24-Fr Chest Drain |
Primary outcome
Postoperative Pneumothorax (PNX)
Time frame: Immediate postoperative period (POD0), postoperative day 1 (POD1), and postoperative day 3 (POD3)
Presence of postoperative PNX assessed by chest X-Ray.
Postoperative Pleural Effusion
Time frame: Immediate postoperative period (POD0), postoperative day 1 (POD1), and postoperative day 3 (POD3)
Presence of residual postoperative pleural effusion assessed by chest X-Ray
6 secondary outcomes
Postoperative Subcutaneous Emphysema
Time frame: During postoperative hospitalization
Postoperative Analgesic Use
Time frame: Immediately after surgery to hospital discharge
Prolonged Air Leak
Time frame: From surgery through chest drain removal, with prolonged air leak defined as lasting more than 5 postoperative days, assessed up to 30 days after surgery
Chest Drain Duration
Time frame: Immediately after surgery to chest drain removal, assessed up to 30 days after surgery
Length of Hospital Stay
Time frame: Immediate after surgery to hospital discharge, assessed up to 30 days after surgery
Postoperative Pain
Time frame: 12, 24, and 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- 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.
Pierfilippo Crucitti, MD Prof. principal investigator
Department of Thoracic Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20-Fr Thoracic Drain and 24-Fr Thoracic Drain in people with Non-Small Cell Lung Cancer, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 18 Sep 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pneumothorax (PNX) (time frame: Immediate postoperative period (POD0), postoperative day 1 (POD1), and postoperative day 3 (POD3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.