Linked Color Imaging Based CMV Diagnosis for Gastric Mucosal Lesions

CMV Criteria in the Detection of Gastric Diseases Using Linked Color Imaging

The newly developed linked color imaging (LCI) system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. This system can obtain bright endoscopic images even at a distant view because LCI has more intense white light than the short-wavelength narrow-band laser light. Short-wavelength narrow-band laser light enhances the vessels on the mucosal surface and the patterns of the mucosa. Therefore, LCI may facilitate the detection of gastric mucosal lesions. Further studies are needed to confirm the clinical utility of LCI.

Study Overview

• Status: Unknown
• Conditions: Gastric Disease
• Intervention / Treatment: Procedure: WLE and then LCI; Procedure: LCI and then WLE

Detailed Description

LCI enhances differences in hue, in the red region of the spectrum, through digital processing. This makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. Based on previous experience, a new LCI based endoscopic diagnosis criteria called CMV (color- microstructure-vessel) criteria has been proposed, which could be used for judging the gastric mucosal lesions. LCI has the advantage of detecting color changes of the mucosa, and this could provide very valuable and useful evidence for making endoscopic diagnosis. In this study, a blinded random controlled clinical trial is designed to further validate the diagnostic value of LCI based CMV criteria for gastric diseases.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100071
    • Affiliated Hospital to Academy of Military Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Above 18 years old patients
• Who agree to participate in the study
• Patients with the indications for gastroduodenoscopy

Exclusion Criteria:

• Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
• Severe uncontrolled coagulopathy
• Prior history of gastric surgery.
• Pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients with indications for gastroduodenoscopy will be evaluated with WLE and then LCI.	Procedure: WLE and then LCI; The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.
Experimental: Group B; Patients with indications for gastroduodenoscopy will be evaluated with LCI and then WLE.	Procedure: LCI and then WLE; The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	Diagnostic accuracy of LCI for gastric diseases was calculated by comparing the LCI endoscopic diagnosis with pathological diagnosis.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of lesions in the stomach	The numbers of lesion detected under WLE and LCI will be recorded and compared.	4 months
Endoscopic examination duration	The time spent on the endoscopic examination using WLE and LCI will be compared.	4 months

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• Ono S, Abiko S, Kato M. Linked color imaging enhances gastric cancer in gastric intestinal metaplasia. Dig Endosc. 2017 Mar;29(2):230-231. doi: 10.1111/den.12757. Epub 2016 Nov 21. No abstract available.
• Min M, Dong TH, Liu Y, Bi YL, Ma CY. Novel endoscopic findings as visualized by non-magnification endoscopy with linked color imaging are indicative of gastric intestinal metaplasia. Chin Med J (Engl). 2019 Apr 5;132(7):782-788. doi: 10.1097/CM9.0000000000000172.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 25, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases
• Other Study ID Numbers: 307-LCI-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No