Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors
A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors
1 other identifier
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2019
CompletedStudy Start
First participant enrolled
March 27, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2020
CompletedFebruary 15, 2024
January 1, 2020
1.6 years
March 27, 2019
February 13, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (3)
Sensitivity and Specificity of detection of gastric lesions
Upon histological confirmation - within 2 weeks of the procedure
Sensitivity and Specificity of detection of oesophageal lesions
Upon histological confirmation - within 2 weeks of the procedure
Sensitivity and Specificity of detection of duodenal lesions
Upon histological confirmation - within 2 weeks of the procedure
Study Arms (2)
Linked Color Imaging - White Light Imaging
OTHERParticipant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging
White Light Imaging - Linked Color Imaging
OTHERParticipant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging
Interventions
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 (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.
Eligibility Criteria
You may qualify if:
- Patients aged 50 years and above
- Patients undergoing gastroscopy for symptom evaluation
- Patients undergoing gastroscopy for surveillance of known intestinal metaplasia
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changi General Hospitallead
- Singapore General Hospitalcollaborator
Study Sites (2)
Singapore General Hospital
Singapore, 169608, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Related 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 diagnosis of active Helicobacter pylori infection. Endosc Int Open. 2016 Jul;4(7):E800-5. doi: 10.1055/s-0042-109049.
PMID: 27556101RESULTPaggi 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 colonoscopy study. Endoscopy. 2018 Apr;50(4):396-402. doi: 10.1055/a-0580-7405. Epub 2018 Mar 14.
PMID: 29539651RESULTYao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.
PMID: 24714327RESULTSun 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.
PMID: 27641243RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tiing Leong Ang, MBBS
Changi General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2019
First Posted
June 18, 2019
Study Start
March 27, 2019
Primary Completion
October 17, 2020
Study Completion
October 17, 2020
Last Updated
February 15, 2024
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share