ISRCTN13584097进行中（未招募）未知
Staging by thoracoscopy in potentially radically treatable non-small cell lung cancer associated with minimal pleural effusion
HS Greater Glasgow and Clyde0 个研究点目标入组 50 人开始时间: 2019年4月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37996118/ (added 24/11/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 18/08/2023:
- •1. Suspected or confirmed stage I-IIIA lung cancer
- •2. Mini-PE, defined as an ipsilateral pleural effusion, resulting in < 1/3 hemithorax opacification on erect chest radiograph which is either:
- •2.1. Too small to safely aspirate after US assessment (level 1 operator judgement)
- •2.2. Cytology-negative after diagnostic aspiration
- •3. Performance Status 0-2
- •4. Radical treatment feasible (Surgery, Radical RT or chemo-RT, +/- immunotherapy)) if OPM is excluded by thoracoscopy (local PI judgement)
- •5. Aged 16 or over
- •6. Informed written or remote consent
- •7. Willingness to comply with scheduled visits, study procedures and laboratory tests
- •Previous participant inclusion criteria:
- •Eligibility Criteria for the Main Study
- •1. Stage I-IIIA NSCLC, after completion of routine staging
- •2. Mini-PE, defined as an ipsilateral pleural effusion, which is = 40 mm in max depth on axial CT scan and either:
- •2.1 Too small to safely aspirate after US assessment (level 1 operator judgement)
- •2.2 Cytology-negative after diagnostic aspiration
- •3. Performance Status 0-2
- •4. Radical treatment feasible (Surgery, Radical RT or chemo-RT) if OPM excluded by LAT (MDT judgement)
- •5. Aged 16 or over
- •6. Informed written consent
- •7. Willingness to comply with scheduled visits, study procedures and laboratory tests
- •Eligibility Criteria for the MRI sub-study
- •1. Registered to the main STRATIFY study
- •2. Informed written consent
- •3. Willingness to comply with scheduled visits, and study procedures
排除标准
- •Current Participant exclusion criteria as of 18/08/2023:
- •1. Any metastatic disease, including confirmed pleural metastases
- •2. Any contraindication to the selected thoracoscopy method when LAT is the preferred method:
- •2.1. Absent lung sliding or extensive fluid loculation on pleural ultrasound (not applicable to VATS) when VATS is the preferred method:
- •2.2. Insufficient fitness for general anaesthesia (not applicable to LAT)
- •3. Uncorrectable bleeding disorder (applicable to LAT and VATS)
- •Previous participant exclusion criteria:
- •Main study:
- •1. Any metastatic disease, including confirmed pleural metastases
- •2. Bilateral pleural effusions
- •3. Any contraindication to LAT, e.g.:
- •3.1 Absent lung-sliding on pleural ultrasound
- •3.2 Uncontrollable cough
- •3.3 Uncorrectable bleeding disorder
- •MRI Sub-study Exclusion Criteria
- •1. Any contraindication to MRI, including but not limited to:
- •1.1 Claustrophobia, pregnancy
- •1.2 Metallic foreign body
- •1.3 Pacemaker/implant
- •1.4 Allergy to Gadolinium contrast
- •1.5 eGFR <30 ml/min
研究者
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