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

Changi General Hospital

Status: Completed

Conditions: Early Gastric Cancer; Barrett Esophagus

Treatments: Diagnostic Test: Linked Color Imaging; Diagnostic Test: White Light Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03990025

2018/2895

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Linked Color Imaging - White Light Imaging

Other group

Description:

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

Treatment:

Diagnostic Test: White Light Imaging

Diagnostic Test: Linked Color Imaging

White Light Imaging - Linked Color Imaging

Other group

Description:

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

Treatment:

Diagnostic Test: White Light Imaging

Diagnostic Test: Linked Color Imaging