Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura

NCT04236037 | Terminated DMC

• 1 other identifier: SJ-787
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

The research group will investigate the diagnostic effect of early introduction of ultrasound guided pleural biopsy in the work-up of patients with one-sided pleural effusion, suspected of malignant pleural effusion.

Conditions

Malignant Pleural Effusion; Exudative Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Proportion of cases with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion.

  Our primary endpoint includes both patients who will receive palliative care and patients who will receive active treatment. For patients receiving palliative care, the presence of malignant cells is sufficient. However, for patients receiving active treatment, the primary endpoint is defined as a definite and treatment-guiding pathological result (immunohistochemistry, mutations, oncodrivers, culture and biochemistry) as decided by a multidisciplinary team conference.

  26 weeks post randomization

Secondary Outcomes (16)

• Proportion of cases achieving pleural immunohistochemistry, mutations, oncodrivers and culture.

  26 weeks post randomization

• Difference in diagnostic yield between Arm A and Arm B, including subgroup analysis of MPE.

  26 weeks post randomization

• Sensitivity of ultrasound-guided closed needle biopsy of parietal pleura for diagnosing malignancy and all causes of PE.

  26 weeks post randomization

• Time from inclusion to conclusive, treatment-guiding diagnoses in patients with MPE.

  26 weeks post randomization

• The negative likelihood ratio of additional ultrasound-guided closed needle biopsy of parietal pleura in aspect of MPE.

  26 weeks post randomization

Study Arms (2)

Ultrasound-guided thoracentesis

ACTIVE COMPARATOR

Ultrasound guided thoracentesis

Procedure: Thoracentesis

Ultrasound-guided pleural biopsy and thoracentesis

EXPERIMENTAL

Ultrasound-guided biopsy of the parietal pleura is taken through the same incision as the optimal site for thoracentesis and immediately prior to ultrasound-guided thoracentesis

Procedure: ultrasound-guided pleural biopsy; Procedure: Thoracentesis

Interventions

ultrasound-guided pleural biopsy PROCEDURE

Using ultrasound the optimal point of entry for thoracentesis is located. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site . Again, the area is wiped with disinfectant and a millimeter small skin incision is made with a pointed scalpel. Six US-guided biopsies of 1.2 millimetres using closed needle biopsies (Quick-core Biopsy Needle 18G, COOK Medical, Bloomington, Indiana, USA or Bard Max Core needle 18G, Temple, Arizona, USA). ) are taken from the parietal pleura. Thoracentesis is performed as described above using the same incision as the pleural biopsy.

Ultrasound-guided pleural biopsy and thoracentesis

Thoracentesis PROCEDURE

The optimal point of entry (the largest distance between parietal and visceral pleura) is identified using ultrasound. This is usually on the lower, dorsal side of the chest. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site. The area is wiped with disinfectant and a millimeter skin incision is made with a pointed scalpel. A 7 French (or up to 16 French, to the choice of the clinician) pigtail catheter is inserted and connected to sealed bag. Fluid is aspirated via a 3-way valve, and transferred to relevant bottles for culture, analysis of albumin and LDH, protein, and for cytology.

Ultrasound-guided pleural biopsy and thoracentesis; Ultrasound-guided 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.
• Patients with a previous thoracentesis of a unilateral exudative pleural effusion according to Light's criteria (1) without malignant cells.
• CT thorax or PET-CT with contrast performed.
• Clinical suspicion of cancer such as (but not limited to) weight loss or PET-CT results or former cancer diagnosis.
• Patients must be able to give informed consent.

You may not qualify if:

• Bilateral pleural effusions.
• Known cause of pleural effusions.
• Life expectancy \<3 months.
• Inability to understand written or spoken Danish.

Sponsors & Collaborators

• Naestved Hospital: lead

Study Sites (2)

Næstved Sygehus, department of pulmonary medicine

Næstved, Region Sjælland, 4700, Denmark

Location

Zealand University Hospital, Roskilde, Department of Pulmonary medicine

Roskilde, Region Sjælland, 4000, Denmark

Location

Related Publications (1)

• Light RW, Macgregor MI, Luchsinger PC, Ball WC Jr. Pleural effusions: the diagnostic separation of transudates and exudates. Ann Intern Med. 1972 Oct;77(4):507-13. doi: 10.7326/0003-4819-77-4-507. No abstract available.

  PMID: 4642731 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Thoracentesis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Uffe Bødtger, MD, PhD,

  Department of Respiratory Medicine; Naestved Hospital, Denmark

  PRINCIPAL INVESTIGATOR

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: October 31, 2019
• First Posted: January 22, 2020
• Study Start: November 11, 2019
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)