Medical Thoracoscopy in Treatment Outcomes of Empyema Management

• Sponsor: Hend Mohamed Sayed Mohamed (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06132997
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 15

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Empyema	Procedure: Thoracoscopy procedure; Procedure: Chest tube thoracostomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Medical thoracoscopy groupMedical thoracoscopy group
• Masking: Single (Participant)
• Masking Description: Intercostal chest tube group
• Primary Purpose: Treatment
• Official Title: Medical Thoracoscopy Versus Conventional Intercostal Tube in Treatment Outcomes of Empyema Management
• Anticipated Study Start Date: Dec 24, 2023
• Anticipated Primary Completion Date: Dec 28, 2024
• Anticipated Study Completion Date: Mar 24, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Medical thoracoscopy group Medical thoracoscopy is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions.	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.; Procedure: Chest tube thoracostomy; Insert chest intercostal tube without thoracoscopy
Active Comparator: Intercostal tube group Intercostal chest tube placed without thoracoscopy for patients with confirmed empyema.	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.; Procedure: Chest tube thoracostomy; Insert chest intercostal tube without thoracoscopy

Outcome Measures

Primary Outcome Measures

1. Treatment success: [baseline]

   Asses by chest ultrasound

Secondary Outcome Measures

1. Success of pleurodesis [baseline]

   measured by assessing the recurrence rate of pleural effusion over a specified follow-up period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hend Mohamed Sayed Mohamed

Investigators

• Study Chair: Mustafa Ahmed, MD, Doctor

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Hend Mohamed Sayed Mohamed, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT06132997
• Other Study ID Numbers: Medical thoracoscopy&Empyem
• First Posted: Nov 15, 2023
• Last Update Posted: Nov 15, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Empyema

Study Results

No Results Posted as of Nov 15, 2023