High Definition Endoscopy and Optic Enhancement Endoscopy in Gastric Neoplasia: A Prospective Study

NCT ID: NCT02863965

Last Updated: 2016-08-11

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

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Brief Summary

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The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia.

Detailed Description

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Conditions

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Gastric Neoplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High definition endoscopy and optic enhancement

All the patients underwent routine preparation before the procedure. The detected lesions in high definition endoscopy were observed with optic enhancement mode. The endoscopist was required to give the real-time descriptions of surface pit patterns of the lesions, based on surface pattern classification. After that, biopsy specimens will be obtained respectively by forceps from each detected lesion recorded for histologic diagnosis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients with dyspeptic symptoms and aged 40 years or older
* or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
* or patients with family history of gastric cancer

Exclusion Criteria

* presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
* presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
* inability to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, PhD. MD.

Role: CONTACT

18678827666

Facility Contacts

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Yanqing Li, PhD. MD.

Role: primary

18678827666

Other Identifiers

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2016SDU-QILU-13

Identifier Type: -

Identifier Source: org_study_id

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