Image-Guided Pleural Needle Biopsy in Pleural Diseases

NCT06541470 | Completed DMC

• 1 other identifier: 03.03.2022.01
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 5

Brief Summary

In recent observational studies show that ultrasound guidance generally increases the success of pleural needle biopsies, it has been shown that the diagnostic success of needle biopsies is compromised and increased when the presence of pleural fluid is associated with a pleural lesion or pleural thickening or pleural nodular lesions. There is no evidence to support a common view on which needle is appropriate in which situation in terms of diagnostic success, reliability of benign diagnoses, and safety of side effects. This study aimed to compare and evaluate the diagnostic yield of the Abrams biopsy needle and the cutting biopsy needle in US-guided pleural needle biopsy to determine which needle is appropriate in which situation. As a result of the study, the diagnostic yield of the cutting needle was found to be higher in cases with pleural thickening of 1 cm or more, and the diagnostic yield of the Abrams needle was found to be higher in patients with pleural thickening of less than 1 cm.

Conditions

Biopsy; Diagnosis; Pleura; Exudate

Keywords

Pleura,; Biopsy; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of pleural needle biopsy

  Diagnostic accuracy, sensitiviy and -LR of pleural needle biopsies with cutting or Abrams needle biopsy.

  12 months

Secondary Outcomes (1)

• Safety of pleural needle biopsy

  12 months

Study Arms (2)

Arm A: Cutting needle biopsy

OTHER

Patients with pleural disease underwent US-assisted cutting needle biopsy.

Procedure: Cutting needle biopsy

Arm B: Abrams needle biopsy

OTHER

Patients with pleural disease underwent US-assisted Abrams needle biopsy.

Procedure: Abrams needle biopsy

Interventions

Cutting needle biopsy PROCEDURE

Effectivity, reliability and safety of pleural needle biopsy in histopathological diagnosis of pleural diseases.

Arm A: Cutting needle biopsy

Abrams needle biopsy PROCEDURE

Effectivity, reliability and safety of pleural needle biopsy in histopathological diagnosis of pleural diseases.

Arm B: Abrams needle biopsy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of exudative pleural effusion for which a specific diagnosis could not be established by clinical, radiological, laboratory, and cytological examination
• Patients who do not have a high risk of side effects or contraindications for the procedures in question (without bleeding diathesis, who can be positioned appropriately for the biopsy procedure)
• Willingness to participate in the study
• Willingness to undergo an invasive procedure
• Willingness to undergo written consent for randomization and participation in the study.

You may not qualify if:

• Presence of parapneumonic effusion
• Patients with consciousness problems
• Any contraindication to pleural biopsy (patients with pathology in the chest wall biopsy site (infection) that would preclude biopsy, patients who are taking blood thinners (anticoagulants/antiaggregants) and cannot be interrupted for the procedure to be performed or can be interrupted by bridging with another blood thinner.)
• Any other systemic disease that could interfere with thoracic computed tomography or ultrasonography assessment.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (5)

ESOGU Medical Faculty Department of Chest Diseases

Eskişehir, Meselik - Eskisehir, 26040, Turkey (Türkiye)

Location

Muzaffer Metintas

Eskişehir, Meselik, 26040, Turkey (Türkiye)

Location

Selma Metintas

Eskişehir, Meselik, 26040, Turkey (Türkiye)

Location

ESOGU Lung and Pleural Cancers Clinical and Research Center

Eskişehir, Meselik, 26220, Turkey (Türkiye)

Location

Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases

Eskişehir, Tepebaşı, 260140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emre Celik, MD

  Eskisehir Osmangazi University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Model Details: Prospective randomized, parallel controlled

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 7, 2024
• Study Start: February 11, 2021
• Primary Completion: February 11, 2024
• Study Completion: June 2, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 MONTHS AFTER PUBLICATION
• Access Criteria: Optional

Locations

TU (5)