Dual-function Semirigid Thoracoscopy Versus Rigid Thoracoscopy for the Diagnosis of Pleural Disease: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 主要终点
- Diagnostic yield
研究概览
简要总结
Medical thoracoscopy (rigid and semirigid) is an effective, safe method for diagnosing and managing pleural diseases. Rigid thoracoscopy demonstrates superior overall diagnostic yield compared to semirigid techniques (flexible forceps/cryobiopsy) due to its ability to obtain larger, deeper biopsies with rigid forceps. However, diagnostic rates become similar when biopsies are successfully obtained.
Limitations of rigid thoracoscopy include restricted maneuverability (especially in posterior/mediastinal areas), increased procedural pain from leveraging against ribs and larger trocars, higher sedation requirements, and a steep learning curve for pulmonologists.
To address these issues, a novel dual-function semirigid thoracoscope (UE FET-680, China) was developed. Its straight working channel accommodates standard rigid biopsy forceps, potentially matching rigid thoracoscopy's diagnostic yield while improving usability. This randomized trial will compare the efficacy and safety of this new device versus conventional rigid thoracoscopy in undiagnosed exudative pleural effusions.
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
- Double (Participant, Outcomes Assessor)
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 unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis;
- •Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
排除标准
- •Patients with PaO2/FiO2 <300;
- •Patients with a tendency for uncontrolled bleeding, unstable cardiovascular status or severe heart failure;
- •Patients with complete pleural symphysis, where it was not possible to create a pneumothorax, were excluded subsequently;
- •Patients with refractory cough;
- •Patients with Eastern Cooperative Oncology Group performance status 4;
- •Patients did not agree to participate in this study;
- •Participation in other studies within three months without withdrawal or termination will affect the observation of this study.
研究组 & 干预措施
Dual-function Semi-rigid Thoracoscopy
干预措施: Dual-function semi-rigid thoracoscopy (Device)
Rigid Thoracoscopy
干预措施: Rigid thoracoscopy (Device)
结局指标
主要结局
Diagnostic yield
时间窗: 7 days after the procedure.
Diagnostic yield is defined as the percentage of participants for whom the allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis. Malignant pleural disease and other defined histopathological diagnoses will be classified as diagnostic results. Non-specific pleuritis, fibrinous pleuritis, non-interpretable specimens, and cases in which no biopsy is obtained will be classified as non-diagnostic results.
次要结局
- Procedural Sedative and Analgesic Requirements(The day of thoracoscopy.)
- Disease-specific Diagnostic Sensitivity(Up to 12 months after thoracoscopy.)
- Sampling Quality of Pleural Biopsy Specimens(Up to 4 weeks after thoracoscopy.)
- Procedure Duration(The day of thoracoscopy.)
- Operator-assessed Device Performance(Immediately after the thoracoscopic procedure)
- Post-thoracoscopy Pain Score(At 2, 6, 12, 24, and 48 hours after thoracoscopy)
- Procedure-related Complications(At discharge from the index hospitalization, up to 30 days after thoracoscopy.)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital