The Role of Decortication in Complex Empyema Cases: Multidrug Resistance and Tuberculosis at the Forefront

NCT ID: NCT07167823

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-08-31

Brief Summary

Empyema is a problem that thoracic surgeons deal in everyday practice. The main goal of treatment is evacuating the pus and fibrin deposits in the thoracic cavity for complete lung expansion. This study aims to report a detailed microbiological profile of patients operated for empyema thoracis and also correlate it with perioperative clinical outcomes. Patients who underwent surgery for empyema thoracis between January 2022 to June 2025 were included in the study. This study was carried out at two centers; Thoracic Surgery Department, Services Hospital Lahore. Patients were taken up for surgery after thorough preoperative evaluation. Perioperative outcomes were correlated with the results of microbiological analysis to evaluate their effect on clinical outcomes. This study highlights the emergence of Gram-negative organisms in bacterial empyema and emergence of multidrug resistance in tubercular empyema. Clinical outcome correlation revealed increased complications in culture-positive cases in both tubercular and nontubercular empyemas

Detailed Description

Pleural empyema, defined as the accumulation of infected pleural fluid, remains a significant clinical challenge globally despite advancements in medical and surgical therapies. In the United States, approximately 32,000 cases of pleural empyema are diagnosed annually , with mortality rates ranging from 5% to 20%. In Pakistan, though national data is lacking, the burden is presumed to be disproportionately higher due to the high prevalence of tuberculosis (TB) and the rising threat of multidrug resistance (MDR). This dual burden necessitates the adoption of robust, evidence-based strategies tailored to the healthcare challenges of the region.

Effective management of empyema requires a multidisciplinary approach involving thoracic surgeons, pulmonologists, infectious disease specialists, and microbiologists. While the initial management focuses on prompt antibiotic therapy and drainage of infected pleural fluid, the emergence of MDR bacterial pathogens and TB-specific challenges complicate the treatment landscape. In particular, MDR bacterial empyemas often demand susceptibility-guided antibiotic regimens, while tuberculous empyemas are complicated by delays in diagnosis and the increasing prevalence of MDR-TB. The intersection of these issues makes individualized management strategies essential in countries like Pakistan, where TB remains a major public health concern.

Surgical intervention is a cornerstone in the management of complicated or refractory empyema, with decortication being the gold-standard procedure to restore lung expansion and achieve definitive source control. At our tertiary care thoracic surgery center, approximately 30-40% of empyema cases require escalation to surgical decortication, consistent with global trends. Both thoracoscopic and open approaches are utilized depending on the stage of the disease and patient-specific factors. Surgical outcomes, however, are influenced by the underlying microbiological profile, as highlighted by a study involving 285 operated cases of empyema thoracis and reported that 58.2% of cases were tubercular in origin, with a mycobacterial culture positivity rate of 19.28%, of which 21.8% were MDR. Nontubercular cases, accounting for 41.8%, were predominantly caused by Gram-negative organisms, with Pseudomonas aeruginosa being the most frequent isolate. These findings align with the microbiological trends observed in our practice, where both MDR pathogens and TB complicate clinical decision-making.

Postoperative management, particularly the duration of antibiotic therapy following decortication, remains a contentious issue with significant variability in global guidelines. The British Thoracic Society recommends a minimum of three weeks of antibiotic therapy, while the American Association of Thoracic Surgery suggests at least two weeks following source control. However, these recommendations are based largely on expert opinion rather than high-quality evidence. Our clinical experience suggests that infectious disease consultation often leads to prolonged antibiotic durations, especially in MDR and tubercular empyema cases. While this approach may reduce recurrence rates, it also carries the risks of adverse drug reactions, increased costs, and the further promotion of antimicrobial resistance. This is particularly concerning in resource-limited settings like Pakistan, where resistance is already a major public health challenge.

The changing microbiological profile of empyema further complicates management. Historically dominated by Gram-positive organisms, the introduction of antibiotics has shifted the burden toward Gram-negative pathogens, many of which exhibit drug resistance. In tubercular empyema, the emergence of MDR-TB presents additional hurdles in both diagnosis and treatment. These microbiological trends highlight the importance of tailored antibiotic and antitubercular regimens informed by culture and sensitivity data. Furthermore, the role of intrapleural fibrinolytics and other adjunctive therapies warrants exploration in our setting, particularly for non-surgical cases.

This study aims to assess the prevalence of multidrug-resistant (MDR) bacterial pathogens and tuberculosis (TB) in patients with empyema requiring surgical intervention. In addition, it seeks to investigate the effectiveness of both thoracoscopic and open decortication techniques in the management of complicated and refractory empyema. By evaluating the microbiological profile and comparing surgical outcomes, the study aims to guide optimal treatment strategies for this challenging condition.

Conditions

Pleural Empyema; Tuberculosis (TB); Bacterial Sepsis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Bacterial empyema thoracis

all participants that were diagnosed as having empyema thoracis due to bacterial organisms, also included multi-drug resistant organisms.

Decortication

Intervention Type: PROCEDURE

removal of fibrinous infected material from pleural cavity and thick fibrous entrapping peel over the lung resulting in full expansion of lung.

Tuberculous Empyema Thoracis

all participants that were diagnosed as having empyema thoracis due to mycobacterium tuberculosis, also included multi-drug resistant organisms.

Decortication

Intervention Type: PROCEDURE

removal of fibrinous infected material and thick fibrinous entrapping peel over the lung

Interventions

Decortication

removal of fibrinous infected material from pleural cavity and thick fibrous entrapping peel over the lung resulting in full expansion of lung.

Intervention Type: PROCEDURE

Decortication

removal of fibrinous infected material and thick fibrinous entrapping peel over the lung

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with pleural empyema based on clinical, radiological, and microbiological confirmation.
• Patients who underwent surgical decortication for complicated or refractory empyema.

Exclusion Criteria

• Patients with non-infectious pleural effusions (e.g., malignant pleural effusion, hemothorax, or chylothorax).
• Empyema cases resolved with medical management alone (antibiotics and/or chest tube drainage) without requiring surgical intervention.
• Patients with severe systemic conditions (e.g., end-stage organ failure, terminal malignancy) where empyema management was not the primary therapeutic focus.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Health Sciences Lahore

OTHER

Sponsor Role: lead

Responsible Party

Zeeshan Sarwar

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Shoaib Nabi, Professor of Thoracic Surgery

Role: PRINCIPAL_INVESTIGATOR

Services Hospital, Lahore

Locations

Services Institute of Medical Sciences (SIMS), Services Hospital, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IRB/2025/1546/SIMS

Identifier Type: -

Identifier Source: org_study_id