NCT02724280

Brief Summary

H. pylori infection plays a very important role in gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally cancer. It is difficult to diagnose H. pylori related gastritis and gastric atrophy on the basis of endoscopic findings. Histology is currently considered to be the gold standard for detecting H. pylori infection. The reliability of detecting H. pylori infection histologically depends on the site, number, and size of gastric biopsy specimens. The blind biopsy sampling of normal appearing mucosa has the risk of missing pathology and sampling errors. Most studies conclude that as well as on expertise in staining and visualizing the bacteria. Considerable error also occurs in identifying gastric atrophy using blind biopsy sampling, and neither the original nor the revised version of the Sydney system reliably identifies more than half the cases in patients with confirmed gastric atrophy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
253

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 18, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

March 18, 2016

Last Update Submit

October 30, 2018

Conditions

GastritisHelicobacter Pylori Associated GastritisAtrophic Gastritis

Outcome Measures

Primary Outcomes (1)

  • Diagnosis rate of normal gastric mucosa, H. pylori associated gastritis and gastric atrophy

    Number of patients with normal gastric mucosa, H. pylori associated gastritis and gastric atrophy will be calculated.

    6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients with indications for gastroduodenoscopy will be evaluated with WLE and then LCI.

Device: WLE and then LCI

Group B

PLACEBO COMPARATOR

Patients with indications for gastroduodenoscopy will be evaluated with LCI and then WLE.

Device: LCI and then WLE

Interventions

WLE and then LCIDEVICE

The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.

Also known as: White light endoscopy (WLE) / linked color imaging (LCI)
Group A
LCI and then WLEDEVICE

The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.

Also known as: Linked color imaging (LCI) / White light endoscopy (WLE)
Group B

Eligibility Criteria

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

You may qualify if:

  • Above 18 years old patients
  • Who agree to participate in the study
  • Patients with the indications for gastroduodenoscopy

You may not qualify if:

  • Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
  • Severe uncontrolled coagulopathy
  • Prior history of gastric surgery.
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, China

Location

Related Publications (2)

  • Anagnostopoulos GK, Yao K, Kaye P, Fogden E, Fortun P, Shonde A, Foley S, Sunil S, Atherton JJ, Hawkey C, Ragunath K. High-resolution magnification endoscopy can reliably identify normal gastric mucosa, Helicobacter pylori-associated gastritis, and gastric atrophy. Endoscopy. 2007 Mar;39(3):202-7. doi: 10.1055/s-2006-945056. Epub 2007 Feb 1.

    PMID: 17273960RESULT

  • Yao K, Anagnostopoulos GK, Ragunath K. Magnifying endoscopy for diagnosing and delineating early gastric cancer. Endoscopy. 2009 May;41(5):462-7. doi: 10.1055/s-0029-1214594. Epub 2009 May 5.

    PMID: 19418401RESULT

MeSH Terms

Conditions

GastritisGastritis, Atrophic

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • Yan Liu, M.D., Ph.D.

    Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 31, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

CN(1)