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

Sponsor
Changi General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03990025
Collaborator
Singapore General Hospital (Other)
100
2
2
18.7
50
2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Linked Color Imaging
  • Diagnostic Test: White Light Imaging
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors
Actual Study Start Date :
Mar 27, 2019
Anticipated Primary Completion Date :
Oct 17, 2020
Anticipated Study Completion Date :
Oct 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Linked Color Imaging - White Light Imaging

Participant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging

Diagnostic Test: Linked Color Imaging
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.

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

Other: White Light Imaging - Linked Color Imaging

Participant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging

Diagnostic Test: Linked Color Imaging
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.

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

Outcome Measures

Primary Outcome Measures

  1. Difference in detection rate of gastric lesions between Linked Color Imaging and White Light Imaging [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 [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 [Immediately following the procedure]

    Includes Duodenal adenoma, Duodenal adenocarcinoma

Secondary Outcome Measures

  1. Sensitivity and Specificity of detection of gastric lesions [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 [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 [Upon histological confirmation - within 2 weeks of the procedure]

    Includes Duodenal adenoma, Duodenal adenocarcinoma

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Singapore General Hospital Singapore Singapore 169608
2 Changi General Hospital Singapore Singapore 529889

Sponsors and Collaborators

  • Changi General Hospital
  • Singapore General Hospital

Investigators

  • Principal Investigator: Tiing Leong Ang, MBBS, Changi General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT03990025
Other Study ID Numbers:
  • 2018/2895
First Posted:
Jun 18, 2019
Last Update Posted:
Jan 23, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2020