Post Operative Pulmonary Air LeakPhase 2NCT07548047
Effectiveness of Dextrose Pleurodesis for the Management of Post-Operative Air Leak
A Phase 2 study testing 50% Dextrose Pleurodesis in people with Post Operative Pulmonary Air Leak, run by Thomas Jefferson University.
Trial summary
A common complication following lung resection surgery is the presence of a post-operative air leak. This occurs when the resected lung tissue does not seal adequately, resulting in continued leakage of air from the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pulmonary Air Leak
- What is being tested?
- 50% Dextrose Pleurodesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Jun 2029
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who have undergone lung resection
- Persistent post-operative air leak >24 hours after surgery with air leak >20 mL/min
Who cannot join
- pregnant patients
- incarcerated patients
- patients with early post-operative complications
- hemodynamic instability
- need for mechanical ventilator support
- high volume chest tube output (>750 mL over 24h)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dextrose Pleurodesis Versus Standard of Care for the Management of Post-Operative Air Leak: A Single Center Prospective Trial
A common complication following lung resection surgery is the presence of a post-operative air leak. This occurs when the resected lung tissue does not seal adequately, resulting in continued leakage of air from the lung. For most patient, an air leak will self-resolve by maintaining a drainage catheter in the chest for a prolonged period. However, for some patients, additional measures are required to help seal the affected tissue. Known strategies for managing post-operative air leak include placing one-way valves, surgical revision, and chemical pleurodesis. Chemical pleurodesis involves injecting an irritant through the chest drainage catheter to promote sealing of the leaking lung tissue. While many agents exist for chemical pleurodesis, a relatively new method for treating an air leak is by using dextrose solution. Dextrose is appealing due to low cost and availability. Dextrose solution has shown some efficacy in other countries and undergone Phase 1 clinical investigation in Canada to show its safety and dosing recommendations. In this study, our aim is to compare the effectiveness of using dextrose solution for treating post-operative air leak compared to usual care with chest tube drainage alone.
- Conditions
- Post Operative Pulmonary Air Leak
- Being tested
- 50% Dextrose Pleurodesis, Standard of Care Chest Drainage
- Keywords
- dextrose, air leak, lung resection, pleurodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% Dextrose PleurodesisDrug
Also called Dextrose, D50
A one time intrapleural instillation of 150mL of dextrose will be administered following analgesia with 10mL lidocaine
Standard of Care Chest DrainageOther
Also called Standard of Care
maintenance of post operative pulmonary drain without additional intervention
| Study group | Role | What they receive |
|---|---|---|
| Dextrose Pleurodesis | Experimental | A one-time intrapleural administration of 150 mL dextrose solution will be administered Receives: Drug: 50% Dextrose Pleurodesis |
| Standard of Care | Active comparator | Patients will maintain chest tube drainage system without additional intervention and air leak will be monitored Receives: Other: Standard of Care Chest Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to air leak resolution
air leak <20mL/min as measured by digital tracking atrium
Measured: from randomization to resolution of air leak (<20 mL/min), assessed up to 30 days
Secondary outcomes (3)
Chest tube duration
time until chest tube removal
Measured: from randomization until chest tube removal, assessed up to 30 days
Hospital Length of Stay
time until patient discharge
Measured: from randomization until hospital discharge, assessed up to 30 days
Adverse Events
occurrence of complications including respiratory failure, pneumonia, and fever
Measured: from randomization through 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pulmonary Air LeakStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olugbenga Okusanya, Thomas Jefferson University
- Investigators
- Olugbenga Okusanya, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548047
- Sponsor's protocol ID
- TJUH-iRISID-2025-0028
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: data will not be shared per internal IRB
Publications
Qiabi, Mehdi. "PLeurodesis Using hypertonic Glucose administration to treat post-operative air leaks following lung resection surgery (PLUG): Phase I trial." (2021).
Tsukioka T, Inoue K, Oka H, Mizuguchi S, Morita R, Nishiyama N. Pleurodesis with a 50% glucose solution in patients with spontaneous pneumothorax in whom an operation is contraindicated. Ann Thorac Cardiovasc Surg. 2013;19(5):358-63. doi: 10.5761/atcs.oa.12.01986. Epub 2012 Dec 26.
PubMed 23269268Fujino K, Motooka Y, Koga T, Osumi H, Matsubara E, Shibata H, Ikeda K, Shiraishi K, Mori T, Hayashi K, Yoshimoto K, Wakimoto J, Kubota I, Suzuki M. Novel approach to pleurodesis with 50 % glucose for air leakage after lung resection or pneumothorax. Surg Today. 2016 May;46(5):599-602. doi: 10.1007/s00595-015-1223-2. Epub 2015 Jul 24.
PubMed 26206407Hong JI, Lee JH, Kim HK. Early Pleurodesis for Postoperative Air Leak with Autologous Blood and 50% Glucose Solution. J Chest Surg. 2023 Jan 5;56(1):16-22. doi: 10.5090/jcs.22.096. Epub 2022 Dec 19.
PubMed 36530129Mueller MR, Marzluf BA. The anticipation and management of air leaks and residual spaces post lung resection. J Thorac Dis. 2014 Mar;6(3):271-84. doi: 10.3978/j.issn.2072-1439.2013.11.29.
PubMed 24624291Stephan F, Boucheseiche S, Hollande J, Flahault A, Cheffi A, Bazelly B, Bonnet F. Pulmonary complications following lung resection: a comprehensive analysis of incidence and possible risk factors. Chest. 2000 Nov;118(5):1263-70. doi: 10.1378/chest.118.5.1263.
PubMed 11083673Elsayed H, McShane J, Shackcloth M. Air leaks following pulmonary resection for lung cancer: is it a patient or surgeon related problem? Ann R Coll Surg Engl. 2012 Sep;94(6):422-7. doi: 10.1308/003588412X13171221592258.
PubMed 22943333Dugan KC, Laxmanan B, Murgu S, Hogarth DK. Management of Persistent Air Leaks. Chest. 2017 Aug;152(2):417-423. doi: 10.1016/j.chest.2017.02.020. Epub 2017 Mar 4.
PubMed 28267436
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextrose Pleurodesis Versus Standard of Care for the Management of Post-Operative Air Leak: A Single Center Prospective Trial
- ClinicalTrials.gov ID
- NCT07548047
- Acronym / sponsor ID
- TJUH-iRISID-2025-0028
- Conditions
- Post Operative Pulmonary Air Leak
- Keywords
- dextrose, air leak, lung resection, pleurodesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 23 Apr 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.
A common complication following lung resection surgery is the presence of a post-operative air leak. This occurs when the resected lung tissue does not seal adequately, resulting in continued leakage of air from the lung. For most patient, an air leak will self-resolve by maintaining a drainage catheter in the chest for a prolonged period. However, for some patients, additional measures are required to help seal the affected tissue. Known strategies for managing post-operative air leak include placing one-way valves, surgical revision, and chemical pleurodesis. Chemical pleurodesis involves injecting an irritant through the chest drainage catheter to promote sealing of the leaking lung tissue. While many agents exist for chemical pleurodesis, a relatively new method for treating an air leak is by using dextrose solution. Dextrose is appealing due to low cost and availability. Dextrose solution has shown some efficacy in other countries and undergone Phase 1 clinical investigation in Canada to show its safety and dosing recommendations. In this study, our aim is to compare the effectiveness of using dextrose solution for treating post-operative air leak compared to usual care with chest tube drainage alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextrose Pleurodesis | Experimental | Drug: 50% Dextrose PleurodesisA one-time intrapleural administration of 150 mL dextrose solution will be administered |
| Standard of Care | Active comparator | Other: Standard of Care Chest DrainagePatients will maintain chest tube drainage system without additional intervention and air leak will be monitored |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who have undergone lung resection
- Persistent post-operative air leak >24 hours after surgery with air leak >20 mL/min
Key exclusion criteria (6 listed)
- pregnant patients
- incarcerated patients
- patients with early post-operative complications
- hemodynamic instability
- need for mechanical ventilator support
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 |
|---|---|---|
| 50% Dextrose PleurodesisAlso: Dextrose, D50A one time intrapleural instillation of 150mL of dextrose will be administered following analgesia with 10mL lidocaine | Drug | Dextrose Pleurodesis |
| Standard of Care Chest DrainageAlso: Standard of Caremaintenance of post operative pulmonary drain without additional intervention | Other | Standard of Care |
Primary outcome
Time to air leak resolution
Time frame: from randomization to resolution of air leak (<20 mL/min), assessed up to 30 days
air leak <20mL/min as measured by digital tracking atrium
3 secondary outcomes
Chest tube duration
Time frame: from randomization until chest tube removal, assessed up to 30 days
Hospital Length of Stay
Time frame: from randomization until hospital discharge, assessed up to 30 days
Adverse Events
Time frame: from randomization through 30 days post-procedure
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 23 Apr 2026.
- BackgroundQiabi, Mehdi. "PLeurodesis Using hypertonic Glucose administration to treat post-operative air leaks following lung resection surgery (PLUG): Phase I trial." (2021).
- Background: PubMed 23269268Tsukioka T, Inoue K, Oka H, Mizuguchi S, Morita R, Nishiyama N. Pleurodesis with a 50% glucose solution in patients with spontaneous pneumothorax in whom an operation is contraindicated. Ann Thorac Cardiovasc Surg. 2013;19(5):358-63. doi: 10.5761/atcs.oa.12.01986. Epub 2012 Dec 26.
- Background: PubMed 26206407Fujino K, Motooka Y, Koga T, Osumi H, Matsubara E, Shibata H, Ikeda K, Shiraishi K, Mori T, Hayashi K, Yoshimoto K, Wakimoto J, Kubota I, Suzuki M. Novel approach to pleurodesis with 50 % glucose for air leakage after lung resection or pneumothorax. Surg Today. 2016 May;46(5):599-602. doi: 10.1007/s00595-015-1223-2. Epub 2015 Jul 24.
- Background: PubMed 36530129Hong JI, Lee JH, Kim HK. Early Pleurodesis for Postoperative Air Leak with Autologous Blood and 50% Glucose Solution. J Chest Surg. 2023 Jan 5;56(1):16-22. doi: 10.5090/jcs.22.096. Epub 2022 Dec 19.
- Background: PubMed 24624291Mueller MR, Marzluf BA. The anticipation and management of air leaks and residual spaces post lung resection. J Thorac Dis. 2014 Mar;6(3):271-84. doi: 10.3978/j.issn.2072-1439.2013.11.29.
- Background: PubMed 11083673Stephan F, Boucheseiche S, Hollande J, Flahault A, Cheffi A, Bazelly B, Bonnet F. Pulmonary complications following lung resection: a comprehensive analysis of incidence and possible risk factors. Chest. 2000 Nov;118(5):1263-70. doi: 10.1378/chest.118.5.1263.
- Background: PubMed 22943333Elsayed H, McShane J, Shackcloth M. Air leaks following pulmonary resection for lung cancer: is it a patient or surgeon related problem? Ann R Coll Surg Engl. 2012 Sep;94(6):422-7. doi: 10.1308/003588412X13171221592258.
- Background: PubMed 28267436Dugan KC, Laxmanan B, Murgu S, Hogarth DK. Management of Persistent Air Leaks. Chest. 2017 Aug;152(2):417-423. doi: 10.1016/j.chest.2017.02.020. Epub 2017 Mar 4.
- Individual participant dataSharing planned: No. data will not be shared per internal IRB
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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.
Olugbenga Okusanya, MD principal investigator
Thomas Jefferson University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50% Dextrose Pleurodesis in people with Post Operative Pulmonary Air Leak, run by Thomas Jefferson University.
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 2 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: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jacob F Woodroof, MD (215-955-6996, jacob.woodroof@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to air leak resolution (time frame: from randomization to resolution of air leak (<20 mL/min), assessed up to 30 days). 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 NCT07548047, which also lists 8 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 23 Apr 2026.