Linked Color Imaging Based CMV Diagnosis for Gastric Mucosal Lesions

Not Applicable

• Conditions: Gastric Disease
• Interventions: Procedure: LCI and then WLE; Procedure: WLE and then LCI

• Registration Number: NCT03092414
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

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.

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 Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-21
• Last Update Submitted: 2017-03-25
• Study First Posted: 2017-03-27
• Last Update Posted: 2017-03-28
• Study Start: 2017-05
• Primary Completion: 2017-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	LCI and then WLE	Patients with indications for gastroduodenoscopy will be evaluated with LCI and then WLE.
Group A	WLE and then LCI	Patients with indications for gastroduodenoscopy will be evaluated with WLE and then LCI.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	4 months	Diagnostic accuracy of LCI for gastric diseases was calculated by comparing the LCI endoscopic diagnosis with pathological diagnosis.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Affiliated Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, China