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

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990025
• Other study ID #: 2018/2895
• Status: Completed
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: October 17, 2020

Study information

• Verified date: January 2020
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 17, 2020
• Est. primary completion date: October 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Barrett Esophagus
• Early Gastric Cancer
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Changi General Hospital	Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

Dohi O, Yagi N, Onozawa Y, Kimura-Tsuchiya R, Majima A, Kitaichi T, Horii Y, Suzuki K, Tomie A, Okayama T, Yoshida N, Kamada K, Katada K, Uchiyama K, Ishikawa T, Takagi T, Handa O, Konishi H, Naito Y, Itoh Y. Linked color imaging improves endoscopic diagn — View Citation

Paggi S, Mogavero G, Amato A, Rondonotti E, Andrealli A, Imperiali G, Lenoci N, Mandelli G, Terreni N, Conforti FS, Conte D, Spinzi G, Radaelli F. Linked color imaging reduces the miss rate of neoplastic lesions in the right colon: a randomized tandem col — View Citation

Sun X, Dong T, Bi Y, Min M, Shen W, Xu Y, Liu Y. Linked color imaging application for improving the endoscopic diagnosis accuracy: a pilot study. Sci Rep. 2016 Sep 19;6:33473. doi: 10.1038/srep33473. — View Citation

Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in detection rate of gastric lesions between Linked Color Imaging and White Light Imaging	Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer	Immediately following the procedure
Primary	Difference in detection rate of oesophageal lesions between Linked Color Imaging and White Light Imaging	Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer	Immediately following the procedure
Primary	Difference in detection rate of duodenal lesions between Linked Color Imaging and White Light Imaging	Includes Duodenal adenoma, Duodenal adenocarcinoma	Immediately following the procedure
Secondary	Sensitivity and Specificity of detection of gastric lesions	Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer	Upon histological confirmation - within 2 weeks of the procedure
Secondary	Sensitivity and Specificity of detection of oesophageal lesions	Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer	Upon histological confirmation - within 2 weeks of the procedure
Secondary	Sensitivity and Specificity of detection of duodenal lesions	Includes Duodenal adenoma, Duodenal adenocarcinoma	Upon histological confirmation - within 2 weeks of the procedure