PDF(Pubmed)
Abstract：
Recurrence rate following radical therapy for lung cancer remains high, potentially reflecting occult metastatic disease, and better staging tools are required. Minimal pleural effusion (mini-PE) is associated with particularly high recurrence risk and is defined as an ipsilateral pleural collection (<1/3 hemithorax on chest radiograph), which is either too small to safely aspirate fluid for cytology using a needle, or from which fluid cytology is negative. Thoracoscopy (local anaesthetic thoracoscopy (LAT) or video-assisted thoracoscopic surgery (VATS)) is the gold-standard diagnostic test for pleural malignancy in patients with larger symptomatic effusions. Staging by Thoracoscopy in potentially radically treatable Lung Cancer associated with Minimal Pleural Effusion (STRATIFY) will prospectively evaluate thoracoscopic staging in lung cancer associated-mini-PE for the first time.
STRATIFY is a prospective multicentre observational study. Recruitment opened in January 2020. The primary objective is to determine the prevalence of detectable occult pleural metastases (OPM). Secondary objectives include assessment of technical feasibility and safety, and the impact of thoracoscopy results on treatment plans, overall survival and recurrence free survival. Inclusion criteria are (1) suspected/confirmed stages I-III lung cancer, (2) mini-PE, (3) Performance Status 0-2 (4), radical treatment feasible if OPM excluded, (5) ≥16 years old and (6) informed consent. Exclusion criteria are any metastatic disease or contraindication to the chosen thoracoscopy method (LAT/VATS). All patients have LAT or VATS within 7 (±5) days of registration, with results returned to lung cancer teams for treatment planning. Following an interim analysis, the sample size was reduced from 96 to 50, based on a lower-than-expected OPM rate. An MRI substudy was removed in November 2022 due to pandemic-related site setup/recruitment delays. These also necessitated a no-cost recruitment extension until October 2023.
Protocol approved by the West of Scotland Research Ethics Committee (Ref: 19/WS/0093). Results will be published in peer-reviewed journals and presented at international meetings.
ISRCTN13584097.
STRATIFY is a prospective multicentre observational study. Recruitment opened in January 2020. The primary objective is to determine the prevalence of detectable occult pleural metastases (OPM). Secondary objectives include assessment of technical feasibility and safety, and the impact of thoracoscopy results on treatment plans, overall survival and recurrence free survival. Inclusion criteria are (1) suspected/confirmed stages I-III lung cancer, (2) mini-PE, (3) Performance Status 0-2 (4), radical treatment feasible if OPM excluded, (5) ≥16 years old and (6) informed consent. Exclusion criteria are any metastatic disease or contraindication to the chosen thoracoscopy method (LAT/VATS). All patients have LAT or VATS within 7 (±5) days of registration, with results returned to lung cancer teams for treatment planning. Following an interim analysis, the sample size was reduced from 96 to 50, based on a lower-than-expected OPM rate. An MRI substudy was removed in November 2022 due to pandemic-related site setup/recruitment delays. These also necessitated a no-cost recruitment extension until October 2023.
Protocol approved by the West of Scotland Research Ethics Committee (Ref: 19/WS/0093). Results will be published in peer-reviewed journals and presented at international meetings.
ISRCTN13584097.
摘要：
背景：肺癌根治性治疗后的复发率仍然很高，潜在反映隐匿性转移性疾病，和更好的分期工具是必需的。最小胸腔积液（mini-PE）与特别高的复发风险相关，被定义为同侧胸膜集合（胸片上<1/3半胸膜），要么太小，无法使用针头安全地抽吸细胞学液体，或液体细胞学检查阴性。胸腔镜检查（局部麻醉胸腔镜检查（LAT）或电视辅助胸腔镜手术（VATS））是对症状性积液较大的患者进行胸膜恶性肿瘤的金标准诊断测试。通过胸腔镜检查在潜在可根本治疗的与微小胸腔积液（STRATIFY）相关的肺癌中进行分期，将首次前瞻性地评估肺癌相关微型PE的胸腔镜分期。
方法：STRATIFY是一项前瞻性多中心观察性研究。2020年1月开始招聘。主要目标是确定可检测的隐匿性胸膜转移（OPM）的患病率。次要目标包括技术可行性和安全性评估，以及胸腔镜检查结果对治疗计划的影响，总生存率和无复发生存率。纳入标准是（1）疑似/确诊I-III期肺癌，（2）迷你PE，（3）性能状态0-2（4），如果排除OPM，根治性治疗可行，（5）≥16岁，（6）知情同意。排除标准是选择的胸腔镜检查方法（LAT/VATS）的任何转移性疾病或禁忌症。所有患者在登记后7（±5）天内进行LAT或VATS，结果返回肺癌团队进行治疗计划。经过中期分析，根据低于预期的OPM率,样本量从96例减少到50例.由于与大流行相关的站点设置/招募延迟，2022年11月取消了一项MRI子研究。这些还需要将免费招聘延长至2023年10月。
背景：苏格兰西部研究伦理委员会批准的协议（编号：19/WS/0093）。结果将在同行评审的期刊上发表，并在国际会议上发表。
背景：ISRCTN13584097。
方法：STRATIFY是一项前瞻性多中心观察性研究。2020年1月开始招聘。主要目标是确定可检测的隐匿性胸膜转移（OPM）的患病率。次要目标包括技术可行性和安全性评估，以及胸腔镜检查结果对治疗计划的影响，总生存率和无复发生存率。纳入标准是（1）疑似/确诊I-III期肺癌，（2）迷你PE，（3）性能状态0-2（4），如果排除OPM，根治性治疗可行，（5）≥16岁，（6）知情同意。排除标准是选择的胸腔镜检查方法（LAT/VATS）的任何转移性疾病或禁忌症。所有患者在登记后7（±5）天内进行LAT或VATS，结果返回肺癌团队进行治疗计划。经过中期分析，根据低于预期的OPM率,样本量从96例减少到50例.由于与大流行相关的站点设置/招募延迟，2022年11月取消了一项MRI子研究。这些还需要将免费招聘延长至2023年10月。
背景：苏格兰西部研究伦理委员会批准的协议（编号：19/WS/0093）。结果将在同行评审的期刊上发表，并在国际会议上发表。
背景：ISRCTN13584097。
