Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Behaviors and Mental Disorders

Pleural Effusion

Lung Neoplasms

Pain

Pleural Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Quality of Life

According to BTS guideline thoracoscopy is the next procedure for patients who remain undiagnosed despite PET-CT and attempts to obtain biopsies. Eligible patients will be randomised to pleuroscopy or VATS. Patients with inconclusive pleuroscopy will proceed to VATS.

50 % of patients will have performed af medical thoracoscopy (pleuroscopy)

Thoracoscopy

50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy

VATS (thoracoscopy)

Uffe Boedtger, MD, PhD

Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is difficult, as the pleural surface is large and \<33% of pleural malignancies shed malignant cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing mutation status for targeted therapies.

Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than conventional CT for detecting malignant lesions \>10mm. However, no randomised trial has investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely PET-positive lesions in e.g. colon, however, lead to more derived tests than do CT alone.

Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows only sampling from the parietal pleura. To date, no randomised studies have compared medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.

Investigators will perform two randomized studies to investigate whether

1. PET/CT is comparable to CT alone
2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.

Rational Approach to a Unilateral Pleural Effusion

Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy

(cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control).

Questionnaire developed to assess the quality of life of cancer patients, QLQC 30

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Rational Approach to a Unilateral Pleural Effusion	NCT03272087	Lung Neoplasms	Thoracoscopy VATS (thoracosc...	18 Years -	Naestved Hospital
Rational Approach to a Unilateral Pleural Effusion	NCT03272087	Lung Neoplasms	Thoracoscopy VATS (thoracosc...	18 Years -	Naestved Hospital

Spots Global Cancer Trial Database for vats (thoracoscopy)