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

NCT ID: NCT03990025

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2020-10-17

Brief Summary

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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

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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.

Conditions

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Early Gastric Cancer Barrett Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Linked Color Imaging - White Light Imaging

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

Group Type OTHER

Linked Color Imaging

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.

White Light Imaging - Linked Color Imaging

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

Group Type OTHER

Linked Color Imaging

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role collaborator

Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiing Leong Ang, MBBS

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status

Changi General Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type RESULT
PMID: 27556101 (View on PubMed)

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 colonoscopy study. Endoscopy. 2018 Apr;50(4):396-402. doi: 10.1055/a-0580-7405. Epub 2018 Mar 14.

Reference Type RESULT
PMID: 29539651 (View on PubMed)

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

Reference Type RESULT
PMID: 24714327 (View on PubMed)

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.

Reference Type RESULT
PMID: 27641243 (View on PubMed)

Other Identifiers

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2018/2895

Identifier Type: -

Identifier Source: org_study_id

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