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

Not Applicable

Completed

• Conditions: Early Gastric Cancer; Barrett Esophagus
• Interventions: Diagnostic Test: Linked Color Imaging; Diagnostic Test: White Light Imaging

• Registration Number: NCT03990025
• Lead Sponsor: Changi General Hospital

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.

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 Timeline

• Study Start: 2019-03-27
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-06-16
• Study First Posted: 2019-06-18
• Status Verified: 2020-01
• Primary Completion: 2020-10-17
• Study Completion: 2020-10-17
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
White Light Imaging - Linked Color Imaging	Linked Color Imaging	Participant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging
White Light Imaging - Linked Color Imaging	White Light Imaging	Participant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging
Linked Color Imaging - White Light Imaging	White Light Imaging	Participant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging
Linked Color Imaging - White Light Imaging	Linked Color Imaging	Participant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging

Primary Outcome Measures

Name	Time	Method
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
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
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

Name	Time	Method
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
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
Sensitivity and Specificity of detection of duodenal lesions	Upon histological confirmation - within 2 weeks of the procedure	Includes Duodenal adenoma, Duodenal adenocarcinoma

Trial Locations

Locations (2)

Singapore General Hospital; 🇸🇬 Singapore, Singapore

Changi General Hospital; 🇸🇬 Singapore, Singapore