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临床试验/NCT04593186
NCT04593186招募中不适用

Trans-oral Magnifying Endoscopy With Narrow Band Imaging for Screening of Nasopharyngeal Carcinoma

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
246
试验地点
1
主要终点
Rate of Newly diagnosed Nasopharyngeal cancer

研究概览

简要总结

Diagnosis of nasopharyngeal carcinoma (NPC) is currently made by trans-nasal endoscopy and biopsy. The small caliber endoscope provides only a limited view of the nasopharynx and may not be able to provide a thorough assessment of the nasopharynx. The investigators have developed a novel endoscopic approach to access the nasopharynx by using a trans-oral high definition endoscope with magnification and image enhancement function. In this cohort study, we aim to investigate the efficacy of diagnosing NPC by applying the novel technique in a high risk patient group with elevated plasma EBV DNA but with negative screening with conventional trans-nasal endoscopy.

详细描述

Nasopharyngeal carcinoma (NPC) is endemic in our region and is the 9th most common cancer in Hong Kong. Traditionally diagnosis has been through a nasoendoscopic examination of the nasopharynx with white light followed by a biopsy of suspicious lesions for a confirmatory diagnosis. However, given the geometry of the anatomy of the nasopharynx, with its inherent crevices and varying amounts of lymphoid tissues, lesions are not always easily identified leading to potential missed lesions. The non-specific aspect of white light also leads to excessive biopsies that are not without risk and of some discomfort to patients. Recent advances in liquid biopsies have also allowed for the detection of earlier and smaller lesions that are not always easily identified on nasoendoscopy but rather are seen on Magnetic Resonance Imaging (MRI).

An alternative imaging technique is the use of Narrow Band Imaging (NBI) to view the vasculature of the mucosa to identify suspicious lesions for pre-malignancy and malignancy that has been popularized in the gastrointestinal tract. In NPC, NBI with the flexible nasoendoscopes has been used in the diagnosis of NPC with varying success. Researchers at Chinese University of Hong Kong has found that in NPC NBI has limitations arising from a lack of consensus on vascular findings on NBI that constitute malignancy, lack of magnification and long focal length of current nasoendoscopes1. Flexible endoscopy using conventional esophago-gastroscopy endoscope (OGD) with NBI and magnification power up to 80x overcome the limitations of current nasoendoscopes. The passage of the endoscope through the mouth and retroflexion at oropharynx could visualize the nasopharynx clearly and detailed assessment is feasible.

Here in this study the investigators will seek to use a trans-oral magnifying endoscopy with NBI and retroflexion into the nasopharynx to view the nasopharynx to evaluate the feasibility in the diagnosis of occult nasopharyngeal carcinoma.

The aim of this study is to investigate the clinical usefulness of trans-oral magnifying endoscopy with NBI as a screening tool for patients at increased risk of nasopharyngeal carcinoma (NPC).

The investigators hypothesize that with the use of magnifying NBI trans-oral endoscopy, the nasopharynx could improve the diagnostic yield of NPC in high risk patients with negative test on conventional investigations. As a result, such endoscopic screening tool could be used routinely to identify early NPC in patients deemed at risk.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male, age ≥ 18 years old
  • Positive result on plasma EBV-DNA analysis
  • No cancer identified on conventional investigations including nasoendoscopy and MRI

排除标准

  • History of nasopharyngeal, oropharyngeal cancer
  • Patients on anticoagulation (Including warfarin and other direct oral anti-coagulants)
  • Bleeding tendency (International Normalized Ratio (INR) > 1.5 or Platelet < 50 x109/L)
  • Trismus, unable to pass oral endoscope
  • Allergic to local anaesthetic agents (Lignocaine)
  • Failure of vital organ (heart, lungs, liver, or kidneys) function
  • Other conditions deemed unsuitable for endoscopy
  • Refusal to participate, or inability to sign consent for study

结局指标

主要结局

Rate of Newly diagnosed Nasopharyngeal cancer

时间窗: 1 month

Newly diagnosed nasopharyngeal cancer with the novel endoscopic approach

次要结局

  • Rate of adverse event - perforation(7 days)
  • Rate of Adverse event - overall(7 days)
  • Rate of adverse event - haemorrhage(7 days)
  • Stage of the newly diagnosed nasopharyngeal cancer(1 month)
  • Rate of adverse event - infection(7 days)
  • Rate of adverse event - aspiration pneumonia(7 days)
  • Duration of the endoscopic procedure(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hon Chi Yip

Associate consultant

Chinese University of Hong Kong

研究点 (1)

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