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

NCT04233359 | Terminated

• 1 other identifier: SJ-790
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pleural Effusion, Malignant; Pleural Effusion; Pleura; Exudate

Keywords

Pleural effusion; Malignant Pleural effusion; Pleura diagnostics; US-guided pleural biopsy; Local anesthetic thoracoscopy

Outcome Measures

Primary Outcomes (2)

• 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

  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

  26 weeks

Secondary Outcomes (15)

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

  26 weeks

• Incidence of completed procedures

  1 week

• Time from randomization to conclusive, treatment-guiding diagnoses

  26 weeks

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

  Day of procedure/intervention

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

  Day of procedure/intervention

Study Arms (2)

US-guided pleural biopsy and thoracentesis

ACTIVE COMPARATOR

Pleural biopsy: Using ultrasound the optimal point of entry for thoracentesis is located, and local anesthesia is obtained. The area is wiped with disinfectant and a skin incision is made with a pointed scalpel. Six US-guided biopsies of 1x2 millimetres are taken from the parietal pleura using closed needle biopsies (Quick-core Biopsy Needle 18G, COOK Medical, Bloomington, Indiana, USA or Bard Max Core Biopsy Needle 18G, Tempe, Arizona, USA). Afterward, a thoracentesis is performed in the same incision as used by the pleural biopsy. A pigtail catheter is inserted and fastened and connected to a sealed bag and fluid is aspirated and sent to relevant analysis.

Procedure: US-guided pleural biopsy

LAT and thoracentesis

EXPERIMENTAL

Local anesthetic thoracoscopy: Pre-procedure a pleural pigtail catheter is inserted and pleural fluid is removed. The catheters one-way valve is opened and the patient takes several breaths thereby creating a pneumothorax prior to procedure start. The patient is sedated with midazolam and morphine. Midaxillary access through intercostal space 4-7 is achieved in local anesthesia and via a skin incision a trocar is placed for access to the thoracic space. A semi-rigid thoracoscope (model LTF 160; Olympus, Tokyo, Japan) is inserted via the trocar and the pleural cavity is inspected after removal of residual effusion whereof at least 40ml is sent to cytology. Pleural parietal biopsies are taken under direct visual guidance. The recommended number of biopsies is 10-15. If no abnormalities were seen, random biopsies are taken. After relevant biopsies are taken the instruments are removed the pigtail catheter stays inserted to allow for removal of air and expansion of the lung.

Procedure: Local anesthetic thoracoscopy

Interventions

Local anesthetic thoracoscopy PROCEDURE

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

Also known as: medical thoracoscopy

LAT and thoracentesis

US-guided pleural biopsy PROCEDURE

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.

US-guided pleural biopsy and thoracentesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naestved Hospital: lead

Study Sites (2)

Næstved Hospital

Næstved, 4700, Denmark

Location

University Hospital Zealand, Roskilde

Roskilde, 4000, Denmark

Location

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MeSH Terms

Conditions

Pleural Effusion, Malignant; Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Uffe Bødtger, MD ph.d.

  Næstved

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: December 20, 2019
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)