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Pleural EmpyemaNCT07167823

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

An observational study of Pleural Empyema and Tuberculosis (TB), run by University of Health Sciences Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Decortication
Type of treatment
Surgery or procedure
How many people
350 participants
Where
1 sitePakistan
Study dates
1 Jan 2022to 31 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Services Institute of Medical Sciences (SIMS), Services Hospital, Lahore

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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.

Being tested
Decortication
Keywords
Multi-drug resistance, Decortication, Bacterial empyema thoracis, tuberculous empyema thoracis
Medical subject headings
Empyema, Pleural, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DecorticationProcedure or surgery

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

  • DecorticationProcedure or surgery

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

Study groups in NCT07167823
Study groupRoleWhat they receive
Bacterial empyema thoracisall participants that were diagnosed as having empyema thoracis due to bacterial organisms, also included multi-drug resistant organisms.
Receives: Procedure: Decortication
Tuberculous Empyema Thoracisall participants that were diagnosed as having empyema thoracis due to mycobacterium tuberculosis, also included multi-drug resistant organisms.
Receives: Procedure: Decortication

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: post-operative day 03 and day 30.

Secondary outcomes (1)
  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).

    Measured: post-operative day 01, day 3, day 07 and day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start1 Jan 2022
  3. Primary completion30 Jun 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07167823
Sponsor's protocol ID
IRB/2025/1546/SIMS
Status last verified
Sep 2025
First submitted
3 Sep 2025
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pleural Empyema and Tuberculosis (TB), run by University of Health Sciences Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

expansion of lung (time frame: post-operative day 03 and day 30.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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