Medical Thoracoscopy in Treatment Outcomes of Empyema Management

Empyema Clinical Trial

Official title:

Medical Thoracoscopy Versus Conventional Intercostal Tube in Treatment Outcomes of Empyema Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06132997
• Other study ID #: Medical thoracoscopy&Empyem
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 24, 2023
• Est. completion date: March 24, 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Hend saleh, MD
• Phone: 01098988712
• Email: hend.m.saleh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 24, 2025
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Empyema

Intervention

Procedure:
• Thoracoscopy procedure
is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions.
• Chest tube thoracostomy
Insert chest intercostal tube without thoracoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hend Mohamed Sayed Mohamed

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success:	Asses by chest ultrasound	baseline
Secondary	Success of pleurodesis	measured by assessing the recurrence rate of pleural effusion over a specified follow-up period.	baseline