Using Local Anesthesia Thoracoscopy as First Test to Diagnose Suspected Malignant Pleural Effusion
Compared to Standard Diagnostic Methods in Adults
Led by National and Kapodistrian University of Athens · Updated on 2025-04-27
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating diagnostic approaches for patients with unexplained lymphocytic pleural effusion suspected to be malignant. The study compares two groups one undergoing immediate Local Anesthesia Thoracoscopy LAT for pleural biopsy and the other receiving the standard diagnostic care involving multiple pleural fluid cytological tests followed by biopsy if needed. The goal is to assess the effectiveness, sensitivity, hospitalization duration, and safety between these methods.
Patients in the study group receive LAT under conscious sedation, where local anesthesia is applied and biopsy samples are taken through a thoracoscope. This procedure also allows for therapeutic pleurodesis if needed. The control group is managed with standard care, including at least three pleural fluid cytology samples and other diagnostic tests, with biopsy referrals made if diagnosis remains uncertain. Both groups undergo imaging and laboratory evaluations as clinically indicated.
Participants are monitored for time to diagnosis and hospital stay length, with assessments extending up to 12 months for diagnosis and 3 months for hospitalization. Additional evaluations include patient discomfort and pain immediately post-procedure and daily until chest tube removal or discharge, as well as monitoring for complications and rates of non-specific pleuritis. Follow-up includes chest X-rays and clinical evaluations, ensuring comprehensive safety and outcome tracking during the study period.
CONDITIONS
Brief Title
First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.
Research Team
N
Nektarios ANAGNOSTOPOULOS, Ass. professor
M
Michail Kon/nos Tsatsis, MD, MSc, PhDc
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Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 12 months
Participants undergo diagnostic procedures to determine the cause of pleural effusion. The LAT Group will have Local Anesthesia Thoracoscopy as the first diagnostic approach, while the Control Group will follow the standard of care involving multiple fluid cytology samples and other tests before biopsy if needed.
Multiple visits depending on diagnostic procedures and clinical assessment
Post-procedure Monitoring
Duration - Up to 2 weeks for pain assessment and chest tube removal; complications monitored up to 3 months
Participants are monitored for pain, complications, and recovery after diagnostic procedures including thoracoscopy and chest tube management.
Daily visits during chest tube management and follow-up visits as needed up to 3 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Baseline predictors of negative and incomplete pleural cytology in patients with suspected pleural malignancy - Data supporting 'Direct to LAT' in selected groups.
Selina Tsim, Sarah Paterson, Douglas Cartwright...