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出境医 / 临床实验 / Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors

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

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.

Condition or disease Intervention/treatment Phase
Early Gastric Cancer Barrett Esophagus Diagnostic Test: Linked Color Imaging Diagnostic Test: White Light Imaging Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : October 17, 2020
Estimated Study Completion Date : October 17, 2020
Arms and Interventions
Arm Intervention/treatment
Linked Color Imaging - White Light Imaging
Participant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging
 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.

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

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.
Outcome Measures
Primary Outcome Measures :
  1. Difference in detection rate of gastric lesions between Linked Color Imaging and White Light Imaging [ Time Frame: Immediately following the procedure ]
    Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer

  2. Difference in detection rate of oesophageal lesions between Linked Color Imaging and White Light Imaging [ Time Frame: Immediately following the procedure ]
    Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer

  3. Difference in detection rate of duodenal lesions between Linked Color Imaging and White Light Imaging [ Time Frame: Immediately following the procedure ]
    Includes Duodenal adenoma, Duodenal adenocarcinoma


Secondary Outcome Measures :
  1. Sensitivity and Specificity of detection of gastric lesions [ Time Frame: Upon histological confirmation - within 2 weeks of the procedure ]
    Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer

  2. Sensitivity and Specificity of detection of oesophageal lesions [ Time Frame: Upon histological confirmation - within 2 weeks of the procedure ]
    Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer

  3. Sensitivity and Specificity of detection of duodenal lesions [ Time Frame: Upon histological confirmation - within 2 weeks of the procedure ]
    Includes Duodenal adenoma, Duodenal adenocarcinoma


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Contacts
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Contact: Tiing Leong Ang, MBBS 67888833 ang.tiing.leong@singhealth.com.sg
Contact: Nway Nway Aye 67888833 nway_nway_aye@cgh.com.sg

Locations
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Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Vikneswaran s/o Namasivayam, MBBS    62223322    vikneswaran.namasivayam@singhealth.com.sg   
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Tiing Leong Ang, MBBS    67888833    ang.tiing.leong@singhealth.com.sg   
Sponsors and Collaborators
Changi General Hospital
Singapore General Hospital
Investigators
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Principal Investigator: Tiing Leong Ang, MBBS Changi General Hospital
Tracking Information
First Submitted Date  ICMJE March 27, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE March 27, 2019
Estimated Primary Completion Date October 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2019)
  • Difference in detection rate of gastric lesions between Linked Color Imaging and White Light Imaging [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Immediately following the procedure ]
    Includes Duodenal adenoma, Duodenal adenocarcinoma
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2019)
  • Sensitivity and Specificity of detection of gastric lesions [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Upon histological confirmation - within 2 weeks of the procedure ]
    Includes Duodenal adenoma, Duodenal adenocarcinoma
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors
Official Title  ICMJE A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Early Gastric Cancer
  • Barrett Esophagus
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Linked Color Imaging - White Light Imaging
    Participant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging
    Interventions:
    • Diagnostic Test: Linked Color Imaging
    • Diagnostic Test: White Light Imaging
  • White Light Imaging - Linked Color Imaging
    Participant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging
    Interventions:
    • Diagnostic Test: Linked Color Imaging
    • Diagnostic Test: White Light Imaging
Publications *
  • 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.
  • 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.
  • Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 17, 2020
Estimated Primary Completion Date October 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tiing Leong Ang, MBBS 67888833 ang.tiing.leong@singhealth.com.sg
Contact: Nway Nway Aye 67888833 nway_nway_aye@cgh.com.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990025
Other Study ID Numbers  ICMJE 2018/2895
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Changi General Hospital
Study Sponsor  ICMJE Changi General Hospital
Collaborators  ICMJE Singapore General Hospital
Investigators  ICMJE
Principal Investigator: Tiing Leong Ang, MBBS Changi General Hospital
PRS Account Changi General Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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