Rational Approach to a Unilateral Pleural Effusion

Summary

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.

Conditions

• Lung Neoplasms

Interventions

DEVICE

Thoracoscopy

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

DEVICE

VATS (thoracoscopy)

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

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• University Hospital, Gentofte, Copenhagen

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Naestved Hospital

  lead OTHER

Principal Investigators

• Uffe Boedtger, MD, PhD · Syddansk Universitet

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2020-12-15

Completion

2020-12-15

Countries

• Denmark

Study Locations