NCT04411589

Brief Summary

The purpose of this study is to valuation of the diagnostic ability of white light imaging and magnifying endoscopy with optical enhancement system in early gastric cancer and intraepithelial neoplasia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

May 24, 2020

Last Update Submit

September 23, 2020

Conditions

Early Gastric Cancer

Keywords

Early gastric cancer, Optical enhancement system

Outcome Measures

Primary Outcomes (1)

  • detection rate of GIN and EGC

    The primary outcome was the detection rate of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) in a per-patient analysis.

    3 months

Secondary Outcomes (4)

  • sensitivity, specificity of diagnostic performances of GIN and EGC

    3 months

  • positive predictive value of diagnostic performances of GIN and EGC

    3 months

  • negative predictive value of diagnostic performances of GIN and EGC

    3 months

  • diagnostic accuracy in a per-biopsy analysis

    3 months

Study Arms (2)

Magnifying endoscopy with optical enhancement system group

EXPERIMENTAL

Patients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system.

Device: magnifying endoscopy with optical enhancement system

white light endoscopy group

ACTIVE COMPARATOR

Patients in this group go through gastroscopy under white light endoscopy.

Device: white light endoscopy system

Interventions

magnifying endoscopy with optical enhancement systemDEVICE

A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. After visualization in white light mode, the stomach was reinspected by using OE mode2. Then, in vivo diagnoses of lesions were made by using OE mode1 according to VS theory. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.

Magnifying endoscopy with optical enhancement system group
white light endoscopy systemDEVICE

A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.

white light endoscopy group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 years with H. pylori infection or histologically verified gastric lesions (chronic atrophic gastritis, intestinal metaplasia, GIN or EGC)
  • Or patients aged 40-80 years from a region with high incidence of gastric cancer
  • Or patients aged 40-80 years with first-degree relative of patients with gastric cancer
  • Or patients aged 40-80 years with high-risk factors for gastric cancer (high salt or pickle diet or smoking or heavy drinking)

You may not qualify if:

  • A history of gastrectomy
  • Active gastrointestinal bleeding or advanced gastric carcinoma
  • Coagulopathy or severe underlying diseases
  • Pregnancy or lactation
  • Absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (1)

  • Wan M, Li GC, Ma MJ, Liu J, Li Z, Zuo XL, Li YQ. Optical enhancement with magnification versus white-light endoscopy for detecting gastric intestinal metaplasia and neoplasia: a randomized controlled trial. Gastrointest Endosc. 2025 Sep;102(3):337-344.e1. doi: 10.1016/j.gie.2025.02.015. Epub 2025 Feb 15.

    PMID: 39956464DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yanqing Li, MD, PhD

    Shandong University Qilu hosipital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, MD, PhD

CONTACT

86-531-82169236liyanqing@sdu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral supervisor of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

May 24, 2020

First Posted

June 2, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2022

Last Updated

September 25, 2020

Record last verified: 2020-09

Locations

CN(1)