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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextrose Pleurodesis | Experimental | A one-time intrapleural administration of 150 mL dextrose solution will be administered |
|
| Standard of Care | Active Comparator | Patients will maintain chest tube drainage system without additional intervention and air leak will be monitored |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50% Dextrose Pleurodesis | Drug | A one time intrapleural instillation of 150mL of dextrose will be administered following analgesia with 10mL lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to air leak resolution | air leak <20mL/min as measured by digital tracking atrium | from randomization to resolution of air leak (<20 mL/min), assessed up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Chest tube duration | time until chest tube removal | from randomization until chest tube removal, assessed up to 30 days |
| Hospital Length of Stay | time until patient discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob F Woodroof, MD | Contact | 215-955-6996 | jacob.woodroof@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Olugbenga Okusanya, MD | Thomas Jefferson University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Qiabi, Mehdi. "PLeurodesis Using hypertonic Glucose administration to treat post-operative air leaks following lung resection surgery (PLUG): Phase I trial." (2021). | ||
| 23269268 | Background | 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. | |
| 26206407 |
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data will not be shared per internal IRB
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D019984 |
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|
| Standard of Care Chest Drainage | Other | maintenance of post operative pulmonary drain without additional intervention |
|
|
| from randomization until hospital discharge, assessed up to 30 days |
| Adverse Events | occurrence of complications including respiratory failure, pneumonia, and fever | from randomization through 30 days post-procedure |
| Background |
| Fujino 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. |
| 36530129 | Background | Hong 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. |
| 24624291 | Background | Mueller 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. |
| 11083673 | Background | Stephan 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. |
| 22943333 | Background | Elsayed 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. |
| 28267436 | Background | Dugan 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. |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |