Clinical trial NCT03990025: 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
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Barrett Esophagus
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2019-06-18
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Difference in detection rate of gastric lesions between Linked Color Imaging and White Light Imaging
timeFrame: Immediately following the procedure
measure: Difference in detection rate of oesophageal lesions between Linked Color Imaging and White Light Imaging
timeFrame: Immediately following the procedure
measure: Difference in detection rate of duodenal lesions between Linked Color Imaging and White Light Imaging
timeFrame: Immediately following the procedure
Secondary outcomes:
measure: Sensitivity and Specificity of detection of gastric lesions
timeFrame: Upon histological confirmation - within 2 weeks of the procedure
measure: Sensitivity and Specificity of detection of oesophageal lesions
timeFrame: Upon histological confirmation - within 2 weeks of the procedure
measure: Sensitivity and Specificity of detection of duodenal lesions
timeFrame: Upon histological confirmation - within 2 weeks of the procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Tiing Leong Ang, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.
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.