Efficacy and Safety of Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.
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 (Participant)
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;
- •Evidence of exudative pleural effusion in which a specific diagnosis could not be determined using clinical, radiological, laboratory, or cytological examinations
- •Willingness to participate in the study and undergo an invasive procedure.;
排除标准
- •Pleural thickening or pleural-based mass without pleural effusion on radiologic examination;
- •Hemodynamic instability;
- •Presence of parapneumonic effusion;
- •Any contraindication to pleural biopsy or semirigid thoracoscopy;
- •Participation in other studies within three months without withdrawal or termination.
研究组 & 干预措施
pCLE guided pleural biopsy via semi-rigid thoracoscopy
pCLE will be introduced to detect suspected areas of the parietal pleura. The pCLE inspection will follow a standardized protocol with two main steps. First, any visible abnormalities under white light, such as nodules or thickening, will be examined with pCLE to evaluate intralesional heterogeneity and determine the best biopsy site. Second, the basal pleura will be systematically swept, covering at least two intercostal spaces above the costophrenic recess, including the diaphragmatic pleura and lower posterior chest wall, which are common sites for malignant involvement. After confirming the targeted area of the parietal pleura for pleural biopsy, the pCLE probe will be withdrawn, and a flexible forceps biopsy will be performed. This process will be repeated eight times, and eight samples will be obtained. All specimens will be transported in separate formalin containers with biopsy sequences for histopathological analysis.
干预措施: Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy (Procedure)
Conventional Pleural biopsy via semi-rigid thoracoscopy
For patients assigned to receive pleural biopsy via semi-rigid thoracoscopy alone, the parietal, visceral, and diaphragmatic pleura will be inspected, and eight biopsies will be obtained under direct vision in all suspected areas of the parietal pleura.
干预措施: Plerual biopsy using medical thoracoscopy (Procedure)
结局指标
主要结局
Diagnostic yield
时间窗: Up to 12 months after the procedure
The proportion of participants in whom a specific diagnosis is established following pleural biopsy via semirigid thoracoscopy, based on histopathological analysis and final reference diagnosis (including 12-month follow-up for initially benign or nonspecific results).
The number of biopsies obtained for pathological diagnosis
时间窗: 12 months
次要结局
- Negative likelihood ratio(Up to 12 months after the procedure)
- Diagnostic sensitivity for specific diseases(Up to 12 months after the procedure)
- Procedural time(Day of procedure)
- Rate of adequate specimens for achieving molecular diagnosis(Within 2 weeks after the procedure (upon pathological reporting))
- Incidence of procedure-related complications(From start of procedure up to 30 days post-procedure (or until chest tube removal and hospital discharge, whichever is longer))
- Sampling quality (tissue depth and interpretability)(Within 2 weeks after the procedure (upon pathological assessment))
- Incidence of operation-related complications(7 days)
- Diagnostic accuracy of pleural diseases(12 months)
- time of operation(the day of operation)
- Overall diagnosis rate of pleural disease(12 months)
研究者
Gang Hou
Chief physician
China-Japan Friendship Hospital