Early Gastric CancerNCT03990025
Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors
A study testing Linked Color Imaging and White Light Imaging in people with Early Gastric Cancer and Barrett Esophagus, run by Changi General Hospital at 2 sites in Singapore.
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Early Gastric Cancer, Barrett Esophagus
- What is being tested?
- Linked Color Imaging and White Light Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSingapore
- Study dates
- 27 Mar 2019to 17 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 50 years and above
- Patients undergoing gastroscopy for symptom evaluation
- Patients undergoing gastroscopy for surveillance of known intestinal metaplasia
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
Singapore, 169608
Changi General Hospital
Singapore, 529889
About this study
Official title: A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors
This study aims to examine the use of Linked Color Imaging in detection of gastric cancer precursors, as well as oesophageal and duodenal lesions.
Read the 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.
- Conditions
- Early Gastric Cancer, Barrett Esophagus
- Being tested
- Linked Color Imaging, White Light Imaging
- Medical subject headings
- Stomach Neoplasms, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linked Color ImagingDiagnostic 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 ImagingDiagnostic test
White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.
| Study group | Role | What they receive |
|---|---|---|
| Linked Color Imaging - White Light Imaging | Other | Participant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging Receives: Diagnostic Test: Linked Color Imaging; Diagnostic Test: White Light Imaging |
| White Light Imaging - Linked Color Imaging | Other | Participant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging Receives: Diagnostic Test: Linked Color Imaging; Diagnostic Test: White Light Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Immediately following the procedure
Difference in detection rate of duodenal lesions between Linked Color Imaging and White Light Imaging
Includes Duodenal adenoma, Duodenal adenocarcinoma
Measured: Immediately following the procedure
Secondary outcomes (3)
Sensitivity and Specificity of detection of gastric lesions
Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer
Measured: Upon histological confirmation - within 2 weeks of the procedure
Sensitivity and Specificity of detection of oesophageal lesions
Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer
Measured: Upon histological confirmation - within 2 weeks of the procedure
Sensitivity and Specificity of detection of duodenal lesions
Includes Duodenal adenoma, Duodenal adenocarcinoma
Measured: Upon histological confirmation - within 2 weeks of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start27 Mar 2019
- Primary completion17 Oct 2020
- Study completion17 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Tiing Leong Ang, MBBS, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990025
- Sponsor's protocol ID
- 2018/2895
- Status last verified
- Jan 2020
- First submitted
- 27 Mar 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27556101Paggi 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.
PubMed 29539651Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.
PubMed 24714327Sun 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.
PubMed 27641243
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors
- ClinicalTrials.gov ID
- NCT03990025
- Acronym / sponsor ID
- 2018/2895
- Conditions
- Early Gastric Cancer, Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 17 Oct 2020 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linked Color Imaging - White Light Imaging | Other | Diagnostic Test: Linked Color Imaging, Diagnostic Test: White Light ImagingParticipant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging |
| White Light Imaging - Linked Color Imaging | Other | Diagnostic Test: Linked Color Imaging, Diagnostic Test: White Light ImagingParticipant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 50 years and above
- Patients undergoing gastroscopy for symptom evaluation
- Patients undergoing gastroscopy for surveillance of known intestinal metaplasia
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linked Color ImagingLinked 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 | Linked Color Imaging - White Light Imaging, White Light Imaging - Linked Color Imaging |
| White Light ImagingWhite Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images. | Diagnostic test | Linked Color Imaging - White Light Imaging, White Light Imaging - Linked Color Imaging |
Primary outcome
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
3 secondary outcomes
Sensitivity and Specificity of detection of gastric lesions
Time frame: Upon histological confirmation - within 2 weeks of the procedure
Sensitivity and Specificity of detection of oesophageal lesions
Time frame: Upon histological confirmation - within 2 weeks of the procedure
Sensitivity and Specificity of detection of duodenal lesions
Time frame: Upon histological confirmation - within 2 weeks of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Results publication: PubMed 27556101Dohi 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 publication: PubMed 29539651Paggi 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 publication: PubMed 24714327Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.
- Results publication: PubMed 27641243Sun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiing Leong Ang, MBBS principal investigator
Changi General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linked Color Imaging and White Light Imaging in people with Early Gastric Cancer and Barrett Esophagus, run by Changi General Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in detection rate of gastric lesions between Linked Color Imaging and White Light Imaging (time frame: Immediately following the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03990025, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.