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

Primary Purpose

Early Gastric Cancer, Barrett Esophagus

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Linked Color Imaging
White Light Imaging
Sponsored by
Changi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Early Gastric Cancer

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Singapore General HospitalRecruiting
  • Changi General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Linked Color Imaging - White Light Imaging

White Light Imaging - Linked Color Imaging

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
Difference in detection rate of duodenal lesions between Linked Color Imaging and White Light Imaging
Includes Duodenal adenoma, Duodenal adenocarcinoma

Secondary Outcome Measures

Sensitivity and Specificity of detection of gastric lesions
Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer
Sensitivity and Specificity of detection of oesophageal lesions
Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer
Sensitivity and Specificity of detection of duodenal lesions
Includes Duodenal adenoma, Duodenal adenocarcinoma

Full Information

First Posted
March 27, 2019
Last Updated
January 22, 2020
Sponsor
Changi General Hospital
Collaborators
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03990025
Brief Title
Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors
Official Title
A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
October 17, 2020 (Anticipated)
Study Completion Date
October 17, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital
Collaborators
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer, Barrett Esophagus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Linked Color Imaging - White Light Imaging
Arm Type
Other
Arm Description
Participant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging
Arm Title
White Light Imaging - Linked Color Imaging
Arm Type
Other
Arm Description
Participant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging
Intervention Type
Diagnostic Test
Intervention Name(s)
Linked Color Imaging
Intervention Description
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
Intervention Name(s)
White Light Imaging
Intervention Description
White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.
Primary Outcome Measure Information:
Title
Difference in detection rate of gastric lesions between Linked Color Imaging and White Light Imaging
Description
Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer
Time Frame
Immediately following the procedure
Title
Difference in detection rate of oesophageal lesions between Linked Color Imaging and White Light Imaging
Description
Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer
Time Frame
Immediately following the procedure
Title
Difference in detection rate of duodenal lesions between Linked Color Imaging and White Light Imaging
Description
Includes Duodenal adenoma, Duodenal adenocarcinoma
Time Frame
Immediately following the procedure
Secondary Outcome Measure Information:
Title
Sensitivity and Specificity of detection of gastric lesions
Description
Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer
Time Frame
Upon histological confirmation - within 2 weeks of the procedure
Title
Sensitivity and Specificity of detection of oesophageal lesions
Description
Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer
Time Frame
Upon histological confirmation - within 2 weeks of the procedure
Title
Sensitivity and Specificity of detection of duodenal lesions
Description
Includes Duodenal adenoma, Duodenal adenocarcinoma
Time Frame
Upon histological confirmation - within 2 weeks of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiing Leong Ang, MBBS
Phone
67888833
Email
ang.tiing.leong@singhealth.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Nway Nway Aye
Phone
67888833
Email
nway_nway_aye@cgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiing Leong Ang, MBBS
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikneswaran s/o Namasivayam, MBBS
Phone
62223322
Email
vikneswaran.namasivayam@singhealth.com.sg
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiing Leong Ang, MBBS
Phone
67888833
Email
ang.tiing.leong@singhealth.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27556101
Citation
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.
Results Reference
result
PubMed Identifier
29539651
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 colonoscopy study. Endoscopy. 2018 Apr;50(4):396-402. doi: 10.1055/a-0580-7405. Epub 2018 Mar 14.
Results Reference
result
PubMed Identifier
24714327
Citation
Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.
Results Reference
result
PubMed Identifier
27641243
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.
Results Reference
result

Learn more about this trial

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

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