Lung NeoplasmsCREATORNCT05358158

Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection

A study testing Intraoperative air leak test, Intraoperative chest drain removal and Standard chest drain placement in people with Lung Neoplasms and Lung Surgery, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Chest drain is used routinely after lung surgery. Despite preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal, these are either retrospective or mainly concerning benign disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Neoplasms, Lung Surgery, Enhanced Recovery After Surgery
What is being tested?: Intraoperative air leak test, Intraoperative chest drain removal and Standard chest drain placement
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 2 sitesDenmark
Study dates: 4 May 2022to 17 Mar 2024
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

Age ≥18 years.
Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules.
first second forced expiratory volume ≥60% of expected.
No increased bleeding risk (e.g. preoperative international normalized ratio >2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).
Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy.
Able and willing to give informed consent.

Who cannot join

Increased risk of post-operative air leak assessed perioperatively by the surgeon (e.g. severe adhesions, bullous/emphysematous lung tissue, defects of the visceral pleura due to iatrogenic or other reasons, suturing in the lung tissue, deep lung resection).
Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing).
Air leak during intraoperative air leak test.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

Thomas Decker Christensen
Aarhus, Aarhus N, 8200
Rigshospitalet
Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection

Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, reduced opioid usage without increasing postoperative complications than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.

Conditions: Lung Neoplasms, Lung Surgery, Enhanced Recovery After Surgery, Fast-track Surgery, Pain, Opioid Use
Being tested: Intraoperative air leak test, Intraoperative chest drain removal, Standard chest drain placement
Medical subject headings: Lung Neoplasms, Pain

What participants receive

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

Intraoperative air leak testProcedure or surgery
A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.
Intraoperative chest drain removalProcedure or surgery
Chest drain is removed intraoperatively.
Standard chest drain placementProcedure or surgery
Chest drain is left in pleura.

Study groups in NCT05358158
Study group	Role	What they receive
Drain-free group	Experimental	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal. Receives: Procedure: Intraoperative air leak test; Procedure: Intraoperative chest drain removal
Chest drain group	Active comparator	Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube. Receives: Procedure: Intraoperative air leak test; Procedure: Standard chest drain placement

What is being measured

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

Acute Pain
Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire at 3 and 6 hours after surgery, and on the morning of postoperative day 1 at 8 a.m
Measured: Up to postoperative day 1
Rescue analgesics
The amount of rescue analgesics given assessed as cumulative amount of morphine during the first 24 hours after surgery milligram equivalents (MME) as defined by pro.medicine.dk hosted by the Danish Association of the Pharmaceutical Industry
Measured: Up to postoperative day 1

Secondary outcomes (9)

Pneumothorax
Number and size of pneumothorax at 6 hours after surgery in the drain-free group, 2 hours after drain removal in the drain group, and postoperative 2-week for both
Measured: Up to postoperative 2 weeks
Complications
Surgical and medical complications including mortality
Measured: Up to postoperative day 30
Chest drain reinsertion
Number and reasons of chest drain reinsertion
Measured: Up to postoperative day 30
Length of stay
Days in hospital after index surgery
Measured: Through post-operative discharge, an average of 2 days
Time to fulfilled discharge criteria
Days to meet discharge criteria but stay in hospital
Measured: Through post-operative discharge, an average of 2 days
Readmission
Number and reasons of readmissions
Measured: Through post-operative admission, an average of 7 days
Quality of recovery after surgery
Evaluate patients' quality of life by questionnaire before surgery, at the first day after surgery
Measured: Up to postoperative day 1
Standard analgesics given
Number of patients who did not receive planned postoperative analgesics according to the standards at their institution
Measured: Up to postoperative 2 weeks
Persistent pain
Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire from postoperative day 2 to 6.
Measured: Up to postoperative day 6

Timeline

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

4 May 202217 Mar 2024

First posted3 May 2022
Study start4 May 2022
Primary completion17 Mar 2024
Study completion17 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
More trials run by Copenhagen University Hospital, RigshospitaletThe 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
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05358158
Sponsor's protocol ID: H-21012837
Acronym: CREATOR
Status last verified: Mar 2024
First submitted: 28 Apr 2022
Last updated: 20 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All IPD that underlie results in a publication are planned to share to other researchers if they connect with the corresponding author of the publication.

Publications

Cerfolio RJ, Bryant AS. The management of chest tubes after pulmonary resection. Thorac Surg Clin. 2010 Aug;20(3):399-405. doi: 10.1016/j.thorsurg.2010.04.001.
PubMed 20619231
Luckraz H, Rammohan KS, Phillips M, Abel R, Karthikeyan S, Kulatilake NE, O'Keefe PA. Is an intercostal chest drain necessary after video-assisted thoracoscopic (VATS) lung biopsy? Ann Thorac Surg. 2007 Jul;84(1):237-9. doi: 10.1016/j.athoracsur.2007.03.007.
PubMed 17588421
Holbek BL, Horsleben Petersen R, Kehlet H, Hansen HJ. Fast-track video-assisted thoracoscopic surgery: future challenges. Scand Cardiovasc J. 2016;50(2):78-82. doi: 10.3109/14017431.2015.1114665. Epub 2015 Dec 1.
PubMed 26514281
Refai M, Brunelli A, Salati M, Xiume F, Pompili C, Sabbatini A. The impact of chest tube removal on pain and pulmonary function after pulmonary resection. Eur J Cardiothorac Surg. 2012 Apr;41(4):820-2; discussion 823. doi: 10.1093/ejcts/ezr126. Epub 2011 Dec 21.
PubMed 22219425
Mao M, Hughes R, Papadimos TJ, Stawicki SP. Complications of chest tubes: a focused clinical synopsis. Curr Opin Pulm Med. 2015 Jul;21(4):376-86. doi: 10.1097/MCP.0000000000000169.
PubMed 26016583
Bardell T, Petsikas D. What keeps postpulmonary resection patients in hospital? Can Respir J. 2003 Mar;10(2):86-9. doi: 10.1155/2003/610570.
PubMed 12693389
Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.
PubMed 22219442
Watanabe 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 15082297
Koc T, Routledge T, Chambers A, Scarci M. Do patients undergoing lung biopsy need a postoperative chest drain at all? Interact Cardiovasc Thorac Surg. 2010 Jun;10(6):1022-5. doi: 10.1510/icvts.2010.232892. Epub 2010 Mar 22.
PubMed 20308263
Holbek BL, Hansen HJ, Kehlet H, Petersen RH. Thoracoscopic pulmonary wedge resection without post-operative chest drain: an observational study. Gen Thorac Cardiovasc Surg. 2016 Oct;64(10):612-7. doi: 10.1007/s11748-016-0692-6. Epub 2016 Aug 10.
PubMed 27510705
Park JB, Hwang JJ, Lee WS, Kim YH, Lee SA. Postoperative chest tube placement after thoracoscopic wedge resection of lung for primary spontaneous pneumothorax: is it mandatory? J Thorac Dis. 2018 Aug;10(8):4812-4818. doi: 10.21037/jtd.2018.07.13.
PubMed 30233854
Liao HC, Yang SM, Hung MH, Cheng YJ, Hsu HH, Chen JS. Thoracoscopic Surgery Without Drainage Tube Placement for Peripheral Lung Nodules. Ann Thorac Surg. 2020 Mar;109(3):887-893. doi: 10.1016/j.athoracsur.2019.10.048. Epub 2019 Dec 13.
PubMed 31843633
Lesser T, Doenst T, Lehmann T, Mukdessi J. Lung Bioposy Without Pleural Drainage. Dtsch Arztebl Int. 2019 May 10;116(19):329-334. doi: 10.3238/arztebl.2019.0329.
PubMed 31288906
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010 Mar 24;11:32. doi: 10.1186/1745-6215-11-32.
PubMed 20334632
Altman DG, Bland JM. Statistics notes: the normal distribution. BMJ. 1995 Feb 4;310(6975):298. doi: 10.1136/bmj.310.6975.298. No abstract available.
PubMed 7866172

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection
ClinicalTrials.gov ID: NCT05358158
Acronym / sponsor ID: CREATOR / H-21012837
Conditions: Lung Neoplasms, Lung Surgery, Enhanced Recovery After Surgery, Fast-track Surgery, Pain, Opioid Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
Collaborators: Aarhus University Hospital
Study start: 4 May 2022 (actual)
Primary completion: 17 Mar 2024 (actual)
Study completion: 17 Mar 2024 (actual)
First posted: 3 May 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Drain-free group	Experimental	Procedure: Intraoperative air leak test, Procedure: Intraoperative chest drain removalParticipants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.
Chest drain group	Active comparator	Procedure: Intraoperative air leak test, Procedure: Standard chest drain placementParticipants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age ≥18 years.
Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules.
first second forced expiratory volume ≥60% of expected.
No increased bleeding risk (e.g. preoperative international normalized ratio >2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).
Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy.

Key exclusion criteria (3 listed)

Increased risk of post-operative air leak assessed perioperatively by the surgeon (e.g. severe adhesions, bullous/emphysematous lung tissue, defects of the visceral pleura due to iatrogenic or other reasons, suturing in the lung tissue, deep lung resection).
Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing).
Air leak during intraoperative air leak test.

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
Intraoperative air leak testA standard 28 Fr chest drain is inserted through the anterior port hole with all port holes closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.	Procedure or surgery	Chest drain group, Drain-free group
Intraoperative chest drain removalChest drain is removed intraoperatively.	Procedure or surgery	Drain-free group
Standard chest drain placementChest drain is left in pleura.	Procedure or surgery	Chest drain group

Primary outcome

Acute Pain
Time frame: Up to postoperative day 1
Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire at 3 and 6 hours after surgery, and on the morning of postoperative day 1 at 8 a.m
Rescue analgesics
Time frame: Up to postoperative day 1
The amount of rescue analgesics given assessed as cumulative amount of morphine during the first 24 hours after surgery milligram equivalents (MME) as defined by pro.medicine.dk hosted by the Danish Association of the Pharmaceutical Industry

9 secondary outcomes

Pneumothorax
Time frame: Up to postoperative 2 weeks
Complications
Time frame: Up to postoperative day 30
Chest drain reinsertion
Time frame: Up to postoperative day 30
Length of stay
Time frame: Through post-operative discharge, an average of 2 days
Time to fulfilled discharge criteria
Time frame: Through post-operative discharge, an average of 2 days
Readmission
Time frame: Through post-operative admission, an average of 7 days
Quality of recovery after surgery
Time frame: Up to postoperative day 1
Standard analgesics given
Time frame: Up to postoperative 2 weeks
Persistent pain
Time frame: Up to postoperative day 6

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 20 Mar 2024.
Results publication: PubMed 20619231Cerfolio RJ, Bryant AS. The management of chest tubes after pulmonary resection. Thorac Surg Clin. 2010 Aug;20(3):399-405. doi: 10.1016/j.thorsurg.2010.04.001.
Results publication: PubMed 17588421Luckraz H, Rammohan KS, Phillips M, Abel R, Karthikeyan S, Kulatilake NE, O'Keefe PA. Is an intercostal chest drain necessary after video-assisted thoracoscopic (VATS) lung biopsy? Ann Thorac Surg. 2007 Jul;84(1):237-9. doi: 10.1016/j.athoracsur.2007.03.007.
Results publication: PubMed 26514281Holbek BL, Horsleben Petersen R, Kehlet H, Hansen HJ. Fast-track video-assisted thoracoscopic surgery: future challenges. Scand Cardiovasc J. 2016;50(2):78-82. doi: 10.3109/14017431.2015.1114665. Epub 2015 Dec 1.
Results publication: PubMed 22219425Refai M, Brunelli A, Salati M, Xiume F, Pompili C, Sabbatini A. The impact of chest tube removal on pain and pulmonary function after pulmonary resection. Eur J Cardiothorac Surg. 2012 Apr;41(4):820-2; discussion 823. doi: 10.1093/ejcts/ezr126. Epub 2011 Dec 21.
Results publication: PubMed 26016583Mao M, Hughes R, Papadimos TJ, Stawicki SP. Complications of chest tubes: a focused clinical synopsis. Curr Opin Pulm Med. 2015 Jul;21(4):376-86. doi: 10.1097/MCP.0000000000000169.
Results publication: PubMed 12693389Bardell T, Petsikas D. What keeps postpulmonary resection patients in hospital? Can Respir J. 2003 Mar;10(2):86-9. doi: 10.1155/2003/610570.
Results publication: PubMed 22219442Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.
Results publication: 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.
Results publication: PubMed 20308263Koc T, Routledge T, Chambers A, Scarci M. Do patients undergoing lung biopsy need a postoperative chest drain at all? Interact Cardiovasc Thorac Surg. 2010 Jun;10(6):1022-5. doi: 10.1510/icvts.2010.232892. Epub 2010 Mar 22.
Results publication: PubMed 27510705Holbek BL, Hansen HJ, Kehlet H, Petersen RH. Thoracoscopic pulmonary wedge resection without post-operative chest drain: an observational study. Gen Thorac Cardiovasc Surg. 2016 Oct;64(10):612-7. doi: 10.1007/s11748-016-0692-6. Epub 2016 Aug 10.
Results publication: PubMed 30233854Park JB, Hwang JJ, Lee WS, Kim YH, Lee SA. Postoperative chest tube placement after thoracoscopic wedge resection of lung for primary spontaneous pneumothorax: is it mandatory? J Thorac Dis. 2018 Aug;10(8):4812-4818. doi: 10.21037/jtd.2018.07.13.
Results publication: PubMed 31843633Liao HC, Yang SM, Hung MH, Cheng YJ, Hsu HH, Chen JS. Thoracoscopic Surgery Without Drainage Tube Placement for Peripheral Lung Nodules. Ann Thorac Surg. 2020 Mar;109(3):887-893. doi: 10.1016/j.athoracsur.2019.10.048. Epub 2019 Dec 13.
Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication are planned to share to other researchers if they connect with the corresponding author of the publication.

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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.

René H Petersen, MD, PhD study chair

Copenhagen University Hospital, Rigshospitalet

Thomas D Christensen, MD, PhD study director

Aarhus University Hospital

Bo L Holbek, MD, PhD principal investigator

Copenhagen University Hospital, Rigshospitalet

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. 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?

Acute Pain (time frame: Up to postoperative day 1). 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?

On the ClinicalTrials.gov record for NCT05358158, which also lists 28 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 20 Mar 2024.