Medical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection-a multicenter, prospective, randomized controlled study: study protocol
Abstract Background Pleural diseases is a common respiratory disorder, mainly characterized as pleural effusion and patients with pleural effusion caused by pneumonia and empyema constituted 29% of the cohort, which suggests pleural infection as the predominant etiology of pleural effusion in China....
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-01-01
|
| Series: | Respiratory Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12931-025-03106-y |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832594505765748736 |
|---|---|
| author | Kaige Wang Linhui Yang Panwen Tian Fen Tan Dan Liu Weimin Li |
| author_facet | Kaige Wang Linhui Yang Panwen Tian Fen Tan Dan Liu Weimin Li |
| author_sort | Kaige Wang |
| collection | DOAJ |
| description | Abstract Background Pleural diseases is a common respiratory disorder, mainly characterized as pleural effusion and patients with pleural effusion caused by pneumonia and empyema constituted 29% of the cohort, which suggests pleural infection as the predominant etiology of pleural effusion in China. Medical thoracoscopy (MT) combined with intrapleural injection of Urokinase holds significant therapeutic value for patients with early to moderate-stage empyema. However, there remains a lack of high-quality evidence regarding the efficacy and safety of combining MT with intrapleural injection of Urokinase administration in patients with pleural infections. Methods This study is a prospective, multicenter, randomized controlled clinical trial involving patients with pleural infections. The intervention involves medical thoracoscopy. The control group receives conventional treatment involving intrapleural urokinase injection followed by chest tube placement for drainage. The study outcomes include efficacy and health economic benefits. The estimated minimum sample size for each group is 64 cases, totaling 128 cases. The study groups are delineated as follows: patients in group A receives intrapleural urokinase injection followed by chest tube placement for drainage, while patients in group B undergoes MT to remove multiple septa and necrotic tissue followed by chest tube placement for drainage, and then intrapleural urokinase injection the day after MT. It is recommended that the diameter of the chest tube be 12–14 F, with three daily flushes of 30 ml normal saline to ensure optimal drainage. Subsequently, comprehensive statistical analyses will be conducted to compare treatment effects and complications across all groups, ultimately leading to conclusive findings. Discussion The study is the first prospective, multicenter clinical trial on the efficacy and safety of medical thoracoscopy combined with intrapleural urokinase injection for the treatment of pleural infection. This study aims to offer clinical guidance for the management of pleural infection. Registration number ChiCTR2300078352 (Registration Date: 2023/12/06). |
| format | Article |
| id | doaj-art-bb76fc9c7e6b476eb5599f39620beb99 |
| institution | Kabale University |
| issn | 1465-993X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Respiratory Research |
| spelling | doaj-art-bb76fc9c7e6b476eb5599f39620beb992025-01-19T12:36:24ZengBMCRespiratory Research1465-993X2025-01-012611710.1186/s12931-025-03106-yMedical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection-a multicenter, prospective, randomized controlled study: study protocolKaige Wang0Linhui Yang1Panwen Tian2Fen Tan3Dan Liu4Weimin Li5Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan UniversityDepartment of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan UniversityDepartment of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan UniversityDepartment of Critical Care Medicine, The Second Xiangya Hospital of Central South UniversityDepartment of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan UniversityDepartment of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan UniversityAbstract Background Pleural diseases is a common respiratory disorder, mainly characterized as pleural effusion and patients with pleural effusion caused by pneumonia and empyema constituted 29% of the cohort, which suggests pleural infection as the predominant etiology of pleural effusion in China. Medical thoracoscopy (MT) combined with intrapleural injection of Urokinase holds significant therapeutic value for patients with early to moderate-stage empyema. However, there remains a lack of high-quality evidence regarding the efficacy and safety of combining MT with intrapleural injection of Urokinase administration in patients with pleural infections. Methods This study is a prospective, multicenter, randomized controlled clinical trial involving patients with pleural infections. The intervention involves medical thoracoscopy. The control group receives conventional treatment involving intrapleural urokinase injection followed by chest tube placement for drainage. The study outcomes include efficacy and health economic benefits. The estimated minimum sample size for each group is 64 cases, totaling 128 cases. The study groups are delineated as follows: patients in group A receives intrapleural urokinase injection followed by chest tube placement for drainage, while patients in group B undergoes MT to remove multiple septa and necrotic tissue followed by chest tube placement for drainage, and then intrapleural urokinase injection the day after MT. It is recommended that the diameter of the chest tube be 12–14 F, with three daily flushes of 30 ml normal saline to ensure optimal drainage. Subsequently, comprehensive statistical analyses will be conducted to compare treatment effects and complications across all groups, ultimately leading to conclusive findings. Discussion The study is the first prospective, multicenter clinical trial on the efficacy and safety of medical thoracoscopy combined with intrapleural urokinase injection for the treatment of pleural infection. This study aims to offer clinical guidance for the management of pleural infection. Registration number ChiCTR2300078352 (Registration Date: 2023/12/06).https://doi.org/10.1186/s12931-025-03106-yPleural infectionMedical thoracoscopyIntrapleural urokinase injection |
| spellingShingle | Kaige Wang Linhui Yang Panwen Tian Fen Tan Dan Liu Weimin Li Medical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection-a multicenter, prospective, randomized controlled study: study protocol Respiratory Research Pleural infection Medical thoracoscopy Intrapleural urokinase injection |
| title | Medical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection-a multicenter, prospective, randomized controlled study: study protocol |
| title_full | Medical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection-a multicenter, prospective, randomized controlled study: study protocol |
| title_fullStr | Medical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection-a multicenter, prospective, randomized controlled study: study protocol |
| title_full_unstemmed | Medical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection-a multicenter, prospective, randomized controlled study: study protocol |
| title_short | Medical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection-a multicenter, prospective, randomized controlled study: study protocol |
| title_sort | medical thoracoscopy combined with intrapleural injection of urokinase for treatment of pleural infection a multicenter prospective randomized controlled study study protocol |
| topic | Pleural infection Medical thoracoscopy Intrapleural urokinase injection |
| url | https://doi.org/10.1186/s12931-025-03106-y |
| work_keys_str_mv | AT kaigewang medicalthoracoscopycombinedwithintrapleuralinjectionofurokinasefortreatmentofpleuralinfectionamulticenterprospectiverandomizedcontrolledstudystudyprotocol AT linhuiyang medicalthoracoscopycombinedwithintrapleuralinjectionofurokinasefortreatmentofpleuralinfectionamulticenterprospectiverandomizedcontrolledstudystudyprotocol AT panwentian medicalthoracoscopycombinedwithintrapleuralinjectionofurokinasefortreatmentofpleuralinfectionamulticenterprospectiverandomizedcontrolledstudystudyprotocol AT fentan medicalthoracoscopycombinedwithintrapleuralinjectionofurokinasefortreatmentofpleuralinfectionamulticenterprospectiverandomizedcontrolledstudystudyprotocol AT danliu medicalthoracoscopycombinedwithintrapleuralinjectionofurokinasefortreatmentofpleuralinfectionamulticenterprospectiverandomizedcontrolledstudystudyprotocol AT weiminli medicalthoracoscopycombinedwithintrapleuralinjectionofurokinasefortreatmentofpleuralinfectionamulticenterprospectiverandomizedcontrolledstudystudyprotocol |