Clinical trial NCT06132997: Medical Thoracoscopy in Treatment Outcomes of Empyema Management
Official title: Medical Thoracoscopy Versus Conventional Intercostal Tube in Treatment Outcomes of Empyema Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Empyema
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Medical thoracoscopy group
Primary purpose: TREATMENT

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

Detailed description: Empyema is a serious infection characterized by pus accumulation in the pleural space. Effective drainage and treatment is necessary for resolution. Traditionally, intercostal tube placement was standard initial management. However, recent studies have compared outcomes of early medical thoracoscopy or video-assisted thoracoscopic surgery (VATS).

Thoracoscopy enables direct visualization for thorough pleural space cleansing and debridement under direct vision. medical thoracoscopy significantly improved drainage adequacy and reduced treatment failure risks compared to tube drainage alone. Also reported shorter hospital stays and lower complication rates with early thoracoscopy-directed management.

Additional benefits of thoracoscopy include enabling talc pleurodesis for reducing empyema recurrence. thoracoscopy-directed pleurodesis achieved higher long-term success rates than tube drainage followed by pleurodesis. Overall, current evidence indicates medical thoracoscopy provides superior empyema treatment outcomes to conventional tube drainage through optimized drainage and debridement under direct visualization.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Treatment success:
timeFrame: baseline
Secondary outcomes:
measure: Success of pleurodesis
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Doctor
name: Mustafa Ahmed, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Aboudara 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.