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临床试验/NCT03990025
NCT03990025已完成不适用

A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors

Changi General Hospital4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
4
主要终点
Difference in detection rate of oesophageal lesions between Linked Color Imaging and White Light Imaging

研究概览

简要总结

This study aims to examine the use of Linked Color Imaging in detection of gastric cancer precursors, as well as oesophageal and duodenal lesions.

详细描述

Gastric cancer is the fifth most common cause of death worldwide. Early detection and removal of gastric cancer precursors and early gastric cancer is crucial for good outcomes. However, these lesions are subtle and often missed by conventional white light imaging (WLI) endoscopy. Image enhanced endoscopy techniques have been developed to enhance the detection and characterization of gastrointestinal lesions. Narrow band imaging (NBI) is one such technique. Though widely used, its drawbacks include a limited far view as a result of the optical filter causing a dark endoscopic view. Linked color imaging (LCI) is a more recent image enhanced endoscopy technique that acquires images by using both narrow-band wavelength light and white light in an appropriate balance, enhancing slight color differences in the red region of mucosa. It has been proven to improve detection of H pylori gastritis and colorectal neoplasms. Thus far, there has been no study to determine whether the use of LCI will increase the detection rate of gastric cancer precursors and early gastric cancer compared to WLI. This study aims to determine whether LCI can increase the detection rate of gastric cancer precursors and early gastric cancer when compared to white light endoscopy, with the null hypothesis being no difference in detection rates. This study will also examine the use of LCI with magnification to predict histology findings for focal lesions seen on endoscopy, as well as the use of LCI in identifying esophageal lesions (such as Barett's esophagus) and duodenal lesions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 50 years and above
  • Patients undergoing gastroscopy for symptom evaluation
  • Patients undergoing gastroscopy for surveillance of known intestinal metaplasia

排除标准

  • Emergent gastroscopy performed for suspected acute GI bleeding
  • Patients with previous surgical/endoscopic resection in stomach
  • Patients with deranged coagulation and platelet function (INR>1.5, Plt<50)
  • Patients with severe comorbid illness (ASA 3 and above)

结局指标

主要结局

Difference in detection rate of oesophageal lesions between Linked Color Imaging and White Light Imaging

时间窗: Immediately following the procedure

Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer

Difference in detection rate of gastric lesions between Linked Color Imaging and White Light Imaging

时间窗: Immediately following the procedure

Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer

Difference in detection rate of duodenal lesions between Linked Color Imaging and White Light Imaging

时间窗: Immediately following the procedure

Includes Duodenal adenoma, Duodenal adenocarcinoma

次要结局

  • Sensitivity and Specificity of detection of gastric lesions(Upon histological confirmation - within 2 weeks of the procedure)
  • Sensitivity and Specificity of detection of oesophageal lesions(Upon histological confirmation - within 2 weeks of the procedure)
  • Sensitivity and Specificity of detection of duodenal lesions(Upon histological confirmation - within 2 weeks of the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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