CClinicalTrials.gg
CompletedNCT07167823Updated Sep 15, 2025

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

An observational study in Pleural Empyema, Tuberculosis (TB) and Bacterial Sepsis, sponsored by University of Health Sciences Lahore. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by University of Health Sciences Lahore · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
350
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Pleural Empyema
  • Tuberculosis (TB)
  • Bacterial Sepsis

Keywords

  • Multi-drug resistance
  • Decortication
  • Bacterial empyema thoracis
  • tuberculous empyema thoracis
03

In context

Empyema, Pleural

30 studies on the registry are indexed under Empyema, Pleural; 10 are open to participants now.

Browse Empyema, Pleural studies →

Lead sponsor

University of Health Sciences Lahore is the lead sponsor of 77 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with pleural empyema (MDR bacterial and tuberculous) who underwent surgical decortication (VATS or open thoracotomy) and admitted in thoracic surgery unit of Services hospital Lahore.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
350 participants (actual)
Patient registry
No

Groups and cohorts

  • Bacterial empyema thoracis

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

    Procedure: Decortication

  • Tuberculous Empyema Thoracis

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

    Procedure: Decortication

Interventions

  • ProcedureDecortication

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

  • ProcedureDecortication

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

06

What researchers measure

Primary outcomes

  1. expansion of lung

    After decortication, complete re-expansion is defined as ≥90% of the ipsilateral hemithorax occupied by aerated lung on standardized postero-anterior chest radiograph, assessed at full inspiration. Results will be reported as the proportion of participants meeting the ≥90% threshold and units of measurement is percent of hemithorax.

    Time frame: post-operative day 03 and day 30.

Secondary outcomes

  1. Post-operative pain

    Pain will be assessed using a Visual Analogue Scale (VAS, 0-10 cm), where 0 = no pain and 10 = worst imaginable pain. Assessments will be performed at rest and during deep inspiration/cough. Scores will be collected by trained nursing staff once daily. The primary analysis will report mean VAS score at each time point (with SD).

    Time frame: post-operative day 01, day 3, day 07 and day 30

07

Study locations

1 site
  • Services Institute of Medical Sciences (SIMS), Services Hospital, Lahore
    Lahore, Punjab Province 54000, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07167823
Lead sponsor
University of Health Sciences Lahore
Responsible party
Zeeshan Sarwar (Principle Investigator, University of Health Sciences Lahore) — Principal investigator
First posted
Sep 11, 2025
Start date
Jan 1, 2022
Primary completion
Jun 30, 2025
Completion
Aug 31, 2025
Last update
Sep 15, 2025

Study contacts

Muhammad Shoaib Nabi, Professor of Thoracic Surgery
principal investigator · Services Hospital, Lahore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion