Linked Color Imaging Based CMV Diagnosis for Gastric Mucosal Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Patients with indications for gastroduodenoscopy will be evaluated with WLE and then LCI.

Group Type EXPERIMENTAL

WLE and then LCI

Intervention Type PROCEDURE

The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.

Group B

Patients with indications for gastroduodenoscopy will be evaluated with LCI and then WLE.

Group Type EXPERIMENTAL

LCI and then WLE

Intervention Type PROCEDURE

The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.

Interventions

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WLE and then LCI

The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.

Intervention Type PROCEDURE

LCI and then WLE

The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes