Medical Thoracoscopy in Treatment Outcomes of Empyema Management

NCT ID: NCT06132997

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-24
• Study Completion Date: 2025-03-24

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.

Conditions

Empyema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Thoracoscopy procedure

Intervention Type: 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

Intervention Type: PROCEDURE

Insert chest intercostal tube without thoracoscopy

Intercostal tube group

Intercostal chest tube placed without thoracoscopy for patients with confirmed empyema.

Group Type: ACTIVE_COMPARATOR

Thoracoscopy procedure

Intervention Type: 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

Intervention Type: PROCEDURE

Insert chest intercostal tube without thoracoscopy

Interventions

Thoracoscopy procedure

is a minimally invasive endoscopic procedure utilized by pulmonologists to evaluate, diagnose, and treat pleural pathologies of the lung, mainly pleural effusions.

Intervention Type: PROCEDURE

Chest tube thoracostomy

Insert chest intercostal tube without thoracoscopy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hend Mohamed Sayed Mohamed

OTHER

Sponsor Role: lead

Responsible Party

Hend Mohamed Sayed Mohamed

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mustafa Ahmed, MD

Role: STUDY_CHAIR

Doctor

Central Contacts

Hend saleh, MD

Role: CONTACT

hend.m.saleh@gmail.com

01098988712

Mohamed yassen, MD

Role: CONTACT

Mfawzy2013@hotmail.com

0100680052

References

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.

Reference Type: BACKGROUND

PMID: 31525811 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30955515 (View on PubMed)

Other Identifiers

Medical thoracoscopy&Empyem

Identifier Type: -

Identifier Source: org_study_id