Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia

NCT ID: NCT03672708

Last Updated: 2019-05-14

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

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-16

Study Completion Date

2019-01-02

Brief Summary

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Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye

Detailed Description

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Conditions

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Gastric Intestinal Metaplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cresyl violet

Group Type OTHER

Cresyl violet

Intervention Type DIAGNOSTIC_TEST

cresyl violet is applicated at the concentration of 0.15% via a spraying catheter to visualize cellular and tissue architecture in the pCLE

Interventions

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Cresyl violet

cresyl violet is applicated at the concentration of 0.15% via a spraying catheter to visualize cellular and tissue architecture in the pCLE

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above
* patients with H. pylori infection, or known GIM or atrophic gastritis

Exclusion Criteria

* patients with a history of GI surgery
* advanced gastric carcinoma or any other malignancy in the GI tract
* acute upper GI bleeding
* patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function
* patients refused to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD,MD

Role: STUDY_DIRECTOR

Department of Gastroenterology,Qilu Hospital,shandong University

Zhen Li, PhD,MD

Role: STUDY_DIRECTOR

Department of Gastroenterology,Qilu Hospital,shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2018SDU-QILU-06

Identifier Type: -

Identifier Source: org_study_id

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