Medical Thoracoscopy in Treatment Outcomes of Empyema Management

Not Applicable

Not yet recruiting

• Conditions: Empyema
• Interventions: Procedure: Thoracoscopy procedure; Procedure: Chest tube thoracostomy

• Registration Number: NCT06132997
• Lead Sponsor: Hend Mohamed Sayed Mohamed

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.

Study Timeline

• Study First Submitted: 2023-10-26
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-09
• Last Update Submitted: 2023-11-09
• Study First Posted: 2023-11-15
• Last Update Posted: 2023-11-15
• Study Start: 2023-12-24
• Primary Completion: 2024-12-28
• Study Completion: 2025-03-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical thoracoscopy group	Thoracoscopy procedure	Medical 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	Thoracoscopy procedure	Intercostal chest tube placed without thoracoscopy for patients with confirmed empyema.
Medical thoracoscopy group	Chest tube thoracostomy	Medical 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	Chest tube thoracostomy	Intercostal chest tube placed without thoracoscopy for patients with confirmed empyema.

Primary Outcome Measures

Name	Time	Method
Treatment success:	baseline	Asses by chest ultrasound

Secondary Outcome Measures

Name	Time	Method
Success of pleurodesis	baseline	measured by assessing the recurrence rate of pleural effusion over a specified follow-up period.