Medical Thoracoscopy in Treatment Outcomes of Empyema Management

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Empyema
• Intervention / Treatment: Procedure: Thoracoscopy procedure; Procedure: Chest tube thoracostomy

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hend saleh, MD; Phone Number: 01098988712; Email: hend.m.saleh@gmail.com
• Study Contact Backup: Name: Mohamed yassen, MD; Phone Number: 0100680052; Email: Mfawzy2013@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success:	Asses by chest ultrasound	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of pleurodesis	measured by assessing the recurrence rate of pleural effusion over a specified follow-up period.	baseline

Collaborators and Investigators

• Sponsor: Hend Mohamed Sayed Mohamed
• Investigators: Study Chair: Mustafa Ahmed, MD, Doctor

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 24, 2023
• Primary Completion (Estimated): December 28, 2024
• Study Completion (Estimated): March 24, 2025

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Empyema
• Other Study ID Numbers: Medical thoracoscopy&Empyem

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No