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临床试验/NCT06541470
NCT06541470已完成不适用

IMAGE-GUIDED PLEURAL NEEDLE BIOPSY IN THE DIAGNOSIS OF PLEURAL DISEASES: ABRAMS NEEDLE OR CUTTING NEEDLE

Eskisehir Osmangazi University10 个研究点 分布在 2 个国家目标入组 148 人开始时间: 2021年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
148
试验地点
10
主要终点
Diagnostic yield of pleural needle biopsy

研究概览

简要总结

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.

详细描述

AIM A significant proportion of the most common exudative pleural effusions, approximately 40-50%, remain undiagnosed despite repeated thoracentesis and associated diagnostic procedures, including cytology. Histopathological analysis is often required for definitive diagnosis in these patients. For histopathological examination, medical thoracoscopy is generally considered to be the most effective and reliable method of obtaining tissue. However, many studies have shown that image-guided/assisted pleural needle biopsies also have a high diagnostic yield.

In recent years, respiratory physician-guided thoracic ultrasound (TUS) has become increasingly popular due to its contribution to managing pleural disease. TUS successfully guide pleural needle biopsies. Although the observational studies show that ultrasound guidance generally increases the success of 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.

METHODS This study was a prospective, randomized, parallel-group study. The Consolidated Standards of Reporting Trials (CONSORT) guidelines were followed for the study protocol. The study was conducted in the Department of Chest Diseases, Faculty of Medicine, Eskisehir Osmangazi University, and Lung and Pleural Cancer Research and Clinical Center from June 2022 to June 2023. The study was approved by the Ethical Committee of Eskisehir Osmangazi University (03.03. 2022/01) and the Ministry of Health ((E-66175679-514.04.01-800014) and was conducted according to the principles of the Declaration of Helsinki. Patients were thoroughly informed before randomization, and their written consent was obtained.

The study included one hundred and seventy-four patients who met the inclusion criteria. Before randomization, all patients underwent contrast-enhanced omputed tomography (CT).

The patients were divided into two groups: The cutting needle group (group A) and the Abrams needle group (group B). Randomization was performed on the subjects enrolled in the study. Block randomization was used with a sequence of 6.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Diagnostic yield of pleural needle biopsy

时间窗: 12 months

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

次要结局

  • Safety of pleural needle biopsy(12 months)

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muzaffer Metintas

Prof. MD

Eskisehir Osmangazi University

研究点 (10)

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