NCT03006588Unknown2 期
Fine Needle Aspiration of Retropharyngeal Lymph Node Guided by Endoscopic Ultrasound for the Diagnosis of Patients With Suspected Recurrent Nasopharyngeal Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Accuracy
研究概览
简要总结
EUS-FNA for RPLN in NPC
详细描述
To evaluate the safety and efficacy of a novel minimally invasive sampling technique -- fine needle aspiration (FNA) guided by endoscopic ultrasound (EUS), which aims to sample tissues from retropharyngeal lymph nodes (RPLN) for the diagnosis of patients with suspected recurrent nasopharyngeal carcinoma (NPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had undifferentiated, non-keratinizing carcinoma at the initial diagnosis (WHO, 1991 criteria) and no evidence of distant metastasis obtained before radiotherapy;
- •received regular chemotherapy with cytotoxic agents such as cisplatin, carboplatin, 5-fluorouracil, paclitaxel, etc, and coordinated with radiotherapy with standard doses (approximate 50-70 Gy) in nasopharynx and neck respectively. Within 3 months after radiotherapy, no local and distant lesions were found;
- •during regular follow-up , the enlarged RPLN was detected by MRI more than 6 months later since radiotherapy accomplished;
- •didn't receive chemotherapy radiotherapy, immunotherapy or salvage surgery from completion of radiotherapy to suspicious recurrent lesion in RPLN detected;
- •no recurrent lesion in nasopharynx was found by white light endoscopy as well as cancer cell negative in pathology by bite biopsy;
- •single lesion in RPLN, and no other recurrent or metastatic lesion was found in local region or distant organ.
- •the minimum axial diameter of RPLN was more than 5mm.
排除标准
- •(1) patients with nasal stenosis; (2) patients with coagulation dysfunction; (3) patients with distant metastasis
结局指标
主要结局
Accuracy
时间窗: Up to 24 weeks
Number of participants with cancer positive and negative
次要结局
未报告次要终点
研究者
Jian-jun Li
Associate Professor
Sun Yat-sen University
研究点 (1)
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