Ultrasounic Elastography-guided Pleural Biopsy Followed by As-needed Medical Thoracoscopic Pleural Biopsy Versus Immediate Medical Thoracoscopic Pleural Biopsy for the Diagnosis of Pleural Effusion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
Brief Summary
The goal of this clinical trial is to determine whether an initial diagnostic approach using ultrasound elastography-guided pleural biopsy (UEPB) is non-inferior to immediate medical thoracoscopic pleural biopsy in terms of diagnostic yield for obtaining a definitive histopathological diagnosis in patients with exudative pleural effusion of unclear etiology.
The main questions it aims to answer are:
Is the step-up strategy (UEPB first, reserving thoracoscopy for non-diagnostic cases) non-inferior to immediate medical thoracoscopy in diagnostic yield?
Does the step-up strategy provide advantages in safety, patient tolerance, hospital stay, and cost-effectiveness compared to immediate thoracoscopy?
Researchers will compare a step-up strategy (initial UEPB, followed by medical thoracoscopy if UEPB is non-diagnostic) versus immediate medical thoracoscopic pleural biopsy to see if the step-up approach achieves comparable diagnostic accuracy while potentially reducing procedure-related burden and healthcare resource use.
Participants will:
Be randomly assigned in a 1:1 ratio to either the step-up strategy arm or the immediate medical thoracoscopy arm.
If assigned to the step-up arm: undergo UEPB under local anesthesia; if the biopsy is non-diagnostic, proceed to semi-rigid medical thoracoscopy.
If assigned to the immediate thoracoscopy arm: undergo semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure.
Provide tissue samples for histopathological, immunohistochemical, and molecular analyses as clinically indicated.
Complete short-term follow-up at 7 days post-procedure (by telephone or clinic visit) to monitor adverse events and symptom recovery.
If initially diagnosed with non-specific benign disease or remain undiagnosed, complete a long-term follow-up at 12 months to establish a final diagnosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Patients with exudative pleural effusion of unknown origin;
- •Patients with negative pleural fluid cytology results;
- •Patients who had not undergone pleural biopsy before enrolment.
排除标准
- •Significantly bleeding risk, including uncorrectable coagulopathy (such as INR >1.5, platelet count <50×109 /L) or the need for ongoing anticoagulant/antiplatelet therapy that cannot be safely paused;
- •Hemodynamic instability;
- •Refractory hypoxemia despite supplemental oxygen;
- •Any severe concurrent illness or cardiopulmonary compromise that, in the investigator's judgment, makes either procedural sedation (for thoracoscopy) or a bedside biopsy (for UEPB) unsafe;
- •Pleural effusion conclusively identified as a transudate;
- •Pregnancy or lactation;
- •Any condition that, in the investigator's judgment, would compromise protocol compliance or follow-up.
研究组 & 干预措施
Step-up strategy
Participants in this arm will first undergo ultrasound elastography-guided pleural biopsy (UEPB) under local anaesthesia. If the biopsy specimen is non-diagnostic, participants will proceed to semi-rigid medical thoracoscopic pleural biopsy under local anaesthesia or moderate sedation.
干预措施: Ultrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsy (Procedure)
Immidiate semi-rigid thoracoscopy
Participants in this arm will undergo semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure. The procedure is performed under local anaesthesia or moderate sedation. Biopsy specimens are obtained under direct visualization from macroscopically abnormal pleural areas.
干预措施: Semi-rigid thoracoscopic pleural biopsy (Procedure)
结局指标
主要结局
Diagnostic yield
时间窗: 7 days after the procedure
The proportion of cases with a specific diagnosis made based on the initial biopsy (UEPB or semi-rigid thoracoscopic pleural biopsy) specimens.
次要结局
- diagnostic sensitivity(7 days after procedure)
- Diagnostic specificity(7 days after procedure)
- The avoidance of semi-rigid thoracoscopy(7 days after the procedure)
- The rate of unexpected chest tube drainage(7 days after procedure)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital