Early Gastric Cancer, Barrett Esophagus
Conditions
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.
Interventions
DIAGNOSTIC_TESTLinked 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_TESTWhite 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.
Sponsors
Singapore General Hospital
Changi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 duodenal lesions between Linked Color Imaging and White Light Imaging | Immediately following the procedure | Includes Duodenal adenoma, Duodenal adenocarcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Singapore
Outcome results
None listed