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

August 8, 2016 updated by: Yanqing Li, Shandong University
The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time Frame: 8 months
8 months
Specificity of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time Frame: 8 months
8 months
Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time Frame: 8 months
8 months
Negative predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The inter-observer and intra-observer agreement of optic enhancement endoscopy in gastric neoplasia
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

July 30, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016SDU-QILU-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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