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

Gastric Neoplasia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02863965
• Other study ID #: 2016SDU-QILU-13
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2016
• Last updated: August 8, 2016
• Start date: March 2016

Study information

• Verified date: July 2016
• Source: Shandong University
• Contact: Yanqing Li, PhD. MD.
• Phone: 18678827666
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Neoplasia
• Neoplasms

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia		8 months	No
Primary	Specificity of optical enhancement endoscopy in diagnosis of gastric neoplasia		8 months	No
Primary	Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia		8 months	No
Primary	Negative predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia		8 months	No
Secondary	The inter-observer and intra-observer agreement of optic enhancement endoscopy in gastric neoplasia		8 months	No