Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152263
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-10-29
Brief Title:
LCI in Chronic Atrophic Gastritis and Early Gastric Cancer
Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Organization:
Affiliated Hospital to Academy of Military Medical Sciences
Study Overview
Official Title:
Color Information From Linked Color Imaging is Associated With Mucosal Microvascular Density in Chronic Atrophic Gastritis and Early Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Color change is a useful marker for the endoscopic identification of chronic atrophic gastritis CAG and gastric cancer GC Several histopathological studies have suggested a correlation between certain gastrointestinal lesions and intramucosal vascularity The aim of this study is to investigate the association between the color and mucosal microvascular density of CAG and early GC using linked color imaging LCI In this study Lesions diagnosed as CAG and early GC will be observed using LCI In each image the color values of atrophic and non-atrophic mucosa as well as cancerous and non-cancerous mucosa will be quantified using the International Commission on Illumination 1976 L a b color space Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining Color differences at the atrophic border and cancerous border defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa as well as cancerous and non-cancerous mucosa will be calculated according to mucosal microvascular density
Detailed Description:
In this study 10 patients diagnosed with CAG or early GC by esophagogastroduodenoscopy at Fifth Medical Center of Chinese PLA General Hospital between September 2023 and December 2023 will be enrolled The following equipment will be used for the study LCI endoscope EG-760Z FUJIFILM Co Tokyo Japan light sources LASEREO LL-4450 Fujifilm Co and video processors AdvanciaHD VP-4450HD FUJIFILM Co During esophagogastroduodenography the atrophic or cancerous border will be identified Following identical compositions images will be continuously captured via LCI Endoscopic biopsy or resection will be performed and the mucosal microvascular density will be histopathologically analyzed using the specimens The color values of atrophic and non-atrophic mucosa as well as cancerous and non-cancerous mucosa will be quantified using the International Commission on Illumination 1976 L a b color space Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining Color differences at the atrophic border and cancerous border defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa as well as cancerous and non-cancerous mucosa will be calculated according to mucosal microvascular density
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None