Image-guided Pleural Needle Biopsy or Medical Thoracoscopy: Which Method for Which Patient? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- The efficacy of pleural biopsy methods for the diagnosis of pleural diseases.
研究概览
简要总结
Pleural diseases can occur due to numerous pathological conditions. The increasing prevalence of etiologic causes and aging population worldwide will make pleural diseases a growing problem in the coming years. As a result of this increase, the need for diagnostic investigations is also increasing. In recent years, the use of image-guided needle biopsies under ultrasound (US) or computed tomography (CT) and the increasing use of medical thoracoscopy (MT) have significantly increased the accuracy of diagnosis of pleural disease. There is not yet a generally accepted algorithm for invasive diagnosis of pleural disease, widely used in clinics, that determines which method should be used in which patient. It would be necessary and valuable to develop an algorithm based on imaging findings in particular to improve the diagnostic accuracy, safety, and cost of the procedure. The investigators aimed to test the algorithm in an interventional study to increase the level of evidence in this study.
详细描述
No consensus exists regarding which biopsy methods are appropriate for specific procedures. In this randomized prospective study, the investigators aimed to compare image guided - pleural biopsy using an Abrams' needle (IG-ANPB) with medical thoracoscopy (MT) according to the CT findings of the patients concerning both diagnostic yield and safety.
Between May 2017 and March 2022, 228 patients with exudative pleural effusion who the cytological analysis could not diagnose were included. All patients were separated into two groups regarding the CT findings: Only pleural effusion or pleural effusion with pleural thickening/lesion. In each group, the patients were randomized to either underwent IG-ANPB or underwent MT. The two groups were compared in terms of diagnostic sensitivity, accuracy, and complications.
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
- Single (Participant)
盲法说明
Participants do not know which method will apply.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pleural effusion Malignant pleural diseases Pleurisy tuberculosis Benign pleural diseases
排除标准
- •Age less than 18 years, Parapneumonic effusion, Presence of other systemic diseases that could interfere radiological evaluation.
研究组 & 干预措施
Only pleural effusion
The patients with only pleural effusion on their CT scans.
干预措施: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases. (Procedure)
Pleural effusion associated with pleural thickening or any other lesion like mass or nodules.
The patients with pleural effusion associated with pleural thickening or any other lesion-like mass or nodules on their CT scans.
干预措施: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases. (Procedure)
结局指标
主要结局
The efficacy of pleural biopsy methods for the diagnosis of pleural diseases.
时间窗: 60 months
To compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.
次要结局
未报告次要终点
研究者
Muzaffer Metintas
Professor
Eskisehir Osmangazi University