A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer.

Naestved Hospital4 enrolled

Overview

Pleural fluid can be caused by cancer. Patients with repeated presentation of pleural fluid where initial diagnostic tests have been inconclusive are the focus of this trial. In this clinical trial patients are randomized into two groups and the efficacy of local anesthetic thoracoscopy (LAT) is compared to an ultrasound guided biopsy of the outer lining of the lung. The aim is not only the diagnostic yield in diagnosing cancer, but also the procedures ability to diagnose specific cancer mutations and immune system markings. Methods and objectives: Patients with reoccuring one-sided pleural fluid, with a marked clinical risk of cancer based on findings in medical work-up, radiological scans, biochemistry and medical history and who are undiagnosed upon initial pleural fluid analysis are the target patients of the trial. Patients are randomized into two groups to have undertaken either pleural biopsy at the optimal site for a repeat thoracentesis or LAT. Thus diagnostic yield for both fluid analysis and biopsy analysis will be compared to tissue samples taken with LAT. We hypothesize that LAT is superior both to pleural biopsy and repeat thoracentesis in providing diagnostic clarification and providing sufficient basis for treatment without further procedures resulting in less time consumption, cost and discomfort for the patient.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pleural Effusion, Malignant

Interventions

Local anesthetic thoracoscopyPROCEDURE

Procedure to obtain histological biopsies of the parietal pleura on awake, fastening patients.

US-guided pleural biopsyPROCEDURE

In local anesthesia, a closed needle biopsy is performed Ultrasound guided of the parietal pleura at the place of deepest fluid recess in the intrathoracic space. A pigtail catheter French 7-16 is placed afterwards for fluid drainage.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older patients with single previous thoracentesis of a unilateral pleural exudate according to Lights criteria without malignant cells. * Lights Criteria: Pleural fluid protein/serum protein ratio greater than 0.5 pleural fluid LDH/serum LDH ratio greater than 0.6 Pleural fluid LDH greater than two-thirds the upper limits of the Laboratorys normal Serum LDH * Contrast enhanced CT of the Chest and abdomen performed * Clinical suspicion of cancer such as, but not limited to, weight loss, malaise, anemia * Pet-CT results or former cancer diagnosis Informed consent Exclusion Criteria: * bilateral pleural effusions * known cause of pleural effusion * likely non-malignant course of a unilateral pleura effusion such as (but not restricted to) pneumonia, trauma, pleuritis, heart failure * any contraindication to the study procedures

Outcomes

Primary Outcomes

Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate, local anesthetic thoracoscopy vs 2. thoracentesis

Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus 2nd thoracentesis

Time frame: 26 weeks

Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate. Local anesthetic thoracoscopy vs US-guided pleural biopsy.

Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus US-guided pleural biopsy prior to 2nd thoracentesis

Time frame: 26 weeks

Secondary Outcomes

Incidence of achieving pleural immunohistochemistry, mutations, oncodrivers, culture and biochemistry.

Time frame: 26 weeks

Incidence of completed procedures

Time frame: 1 week

Time from randomization to conclusive, treatment-guiding diagnoses

Time frame: 26 weeks

Time from start of consultation with medical staff until end of consultation with medical staff on the day of the procedure

Time frame: Day of procedure/intervention

Time from procedure start to patient leaving the procedure room and leaving the recovery room

Time frame: Day of procedure/intervention

Adverse event; complication to procedure: mortality