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Completed

NCT Number: NCT03990025

Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors

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

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Key information

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Linked Color Imaging

Diagnostic Test

Linked Color Imaging (LCI) is a form of image enhanced endoscopy that uses a laser endoscopic system that acquires images by simultaneously using narrow-band wavelength light and white light in an appropriate balance. This enhances slight color differences in the red region of the mucosa.

White Light Imaging

Diagnostic Test

White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.

Primary outcomes

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

    Time frame: Immediately following the procedure

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

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

    Time frame: Immediately following the procedure

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

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

    Time frame: Immediately following the procedure

    Includes Duodenal adenoma, Duodenal adenocarcinoma

Secondary outcomes

  1. Sensitivity and Specificity of detection of gastric lesions

    Time frame: Upon histological confirmation - within 2 weeks of the procedure

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

  2. Sensitivity and Specificity of detection of oesophageal lesions

    Time frame: Upon histological confirmation - within 2 weeks of the procedure

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

  3. Sensitivity and Specificity of detection of duodenal lesions

    Time frame: Upon histological confirmation - within 2 weeks of the procedure

    Includes Duodenal adenoma, Duodenal adenocarcinoma

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Collaborators

  • Singapore General Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2019
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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