Medical Thoracoscopy in Treatment Outcomes of Empyema Management
Medical Thoracoscopy Versus Conventional Intercostal Tube in Treatment Outcomes of Empyema Management
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
To evaluate the efficacy of drainage achieved by thoracoscopy vs tube drainage alone. To compare clinical outcomes such as length of hospital stay, need for additional procedures, and treatment failure rates between the two drainage methods. To asses resolution of pleural infection and rates of fluid re-accumulation over follow-up. To compare safety profiles and complication rates of thoracoscopy versus tube drainage alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2023
CompletedFirst Posted
Study publicly available on registry
November 15, 2023
CompletedStudy Start
First participant enrolled
December 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2025
CompletedNovember 15, 2023
November 1, 2023
1 year
October 26, 2023
November 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment success:
Asses by chest ultrasound
baseline
Secondary Outcomes (1)
Success of pleurodesis
baseline
Study Arms (2)
Medical thoracoscopy group
ACTIVE COMPARATORMedical thoracoscopy is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions.
Intercostal tube group
ACTIVE COMPARATORIntercostal chest tube placed without thoracoscopy for patients with confirmed empyema.
Interventions
is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions.
Insert chest intercostal tube without thoracoscopy
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of empyema via Imaging tests (e.g. chest x-ray/CT scan)
- Age 18 years or older
- Clinical signs/symptoms consistent with Empyema such as fever, chest pain, coughs
- Pleural fluid loculations/septations seen on Imaging requiring drainage
- No previous drainage procedures done for Current empyema
You may not qualify if:
- Age less than 18 years
- Immunocompromised state or other conditions Contraindications to thoracoscopy
- Previous drainage procedure for current Empyema
- Residual pleural fluid not amenable to drain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Godfrey MS, Bramley KT, Detterbeck F. Medical and Surgical Management of Empyema. Semin Respir Crit Care Med. 2019 Jun;40(3):361-374. doi: 10.1055/s-0039-1694699. Epub 2019 Sep 16.
PMID: 31525811BACKGROUNDAboudara M, Maldonado F. Update in the Management of Pleural Effusions. Med Clin North Am. 2019 May;103(3):475-485. doi: 10.1016/j.mcna.2018.12.007.
PMID: 30955515BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mustafa Ahmed, MD
Doctor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Intercostal chest tube group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 26, 2023
First Posted
November 15, 2023
Study Start
December 24, 2023
Primary Completion
December 28, 2024
Study Completion
March 24, 2025
Last Updated
November 15, 2023
Record last verified: 2023-11