此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Endoscopy Screening for Esophageal Cancer

2010年10月18日 更新者:Lotung Poh-Ai Hospital

Endoscopy Screening for Esophageal Neoplasm With Narrow Band Imaging in Patients With Head and Neck Cancer: A Controlled Tandem Endoscopy Trial

Patients with head and neck cancer frequently develop synchronous or metachronous esophageal malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions. However, whether the application of NBI improves the detection results have not been critically evaluated.

This study aims to investigate the diagnostic value of the NBI system in the endoscopic screening for esophageal neoplastic lesions in patients with head and neck cancer.

研究概览

详细说明

This is a prospective blinded controlled tandem endoscopy trial conducted in a regional medical center (Lotung Poh-Ai Hospital, Taiwan). Patients with tissue diagnosis of head and neck cancer are enrolled. Endoscopy screening for esophageal lesions is first performed by using the conventional white light system. Suspicious lesions are recorded. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy. After the endoscopic inspection completed, all suspicious lesions are biopsied. Before each procedure, which one of the two participating endoscopists applies the conventional or NBI system is randomized. The diagnostic rate of esophageal neoplasm by the conventional white light system and that of the NBI system are compared.

The endpoint is the neoplastic lesion detected on endoscopic biopsy. We considered invasive cancer, carcinoma in-situ, and high-grade dysplasia (which usually cannot be distinguished from carcinoma in situ) as the primary points. Any dysplastic lesions were considered as secondary points.

研究类型

观察性的

注册 (预期的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Yilan、台湾、265
        • Lotung Poh-Ai Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with tissue diagnosis of head and neck carcinoma

描述

Inclusion Criteria:

  • patients with tissue diagnosis of head and neck cancer
  • histopathology of head and neck cancer is carcinoma (including squamous cell carcinoma, adenocarcinoma or undifferentiated)
  • aged more than 18 years old
  • agree to under go upper gastrointestinal endoscopy

Exclusion Criteria:

  • lack of written informed consent
  • the origin of head and neck cancer is metastatic
  • histopathology of head and neck cancer is not carcinoma (e.g., sarcoma, lymphoma, etc)
  • incomplete upper gastrointestinal endoscopy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Endoscopy screening
Patients with tissue diagnosis of head and neck cancer undergo endoscopy screening with conventional white light system first. Then the entire esophagus is examined under the NBI system by another endoscopist, who is blinded to the result of the conventional endoscopy.
Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions.
其他名称:
  • 北向接口

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia
大体时间:Within 3 days of endoscopy examination
Within 3 days of endoscopy examination

次要结果测量

结果测量
大体时间
Pathological interpretation of biopsy specimen for any grade of dysplasia
大体时间:within 3 days of endoscopy examination
within 3 days of endoscopy examination

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tzeng-Huey Yang, M.D.、Lotung Poh-Ai Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年6月1日

初级完成 (实际的)

2010年4月1日

研究完成 (实际的)

2010年4月1日

研究注册日期

首次提交

2009年6月22日

首先提交符合 QC 标准的

2009年6月24日

首次发布 (估计)

2009年6月25日

研究记录更新

最后更新发布 (估计)

2010年10月19日

上次提交的符合 QC 标准的更新

2010年10月18日

最后验证

2010年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • OMCP-98-006

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅