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Status unknownNCT01646528Updated Jul 20, 2012

The Value of Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

An observational study in Gastric Intestinal Metaplasia, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-07-20.

Sponsored by Shandong University · Observational

The sponsor has not verified this record recently (last verified Jul 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study aims to:

  1. Explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy (CLE).
  2. Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.
Read the detailed description

Gastric intestinal metaplasia (GIM) is confirmed to be a risk factor that may lead to the development of intestinal type gastric cancer. Previous study has shown that confocal laser endomicroscopy promising in the diagnosis of GIM. The investigators have found an elevated incidence of mesenchymal black spots in patients with GIM during previous CLE imaging. This study aims to explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy.

02

Conditions studied

  • Gastric Intestinal Metaplasia

Keywords

  • Gastric Intestinal Metaplasia
  • Confocal Laser Endomicroscopy
03

In context

Lead sponsor

Shandong University is the lead sponsor of 291 studies on the registry; 59 are open to participants now.

Browse Shandong University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients without any disease of heart, liver or kidney.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients will include male or female aged between 18 and 80 years with indications for upper-endoscopy , but without any disease of heart, liver or kidney.

Exclusion criteria

Exclusion Criteria:

  • Patients who are allergic to fluorescein sodium
  • Patients who are unwilling to sign or give the informed consent form
  • Patients with impaired cardiac, liver or renal function
  • Patients with coagulopathy
  • Patients with pregnancy or breastfeeding
05

Study design

Time perspective
Prospective
Enrollment
30 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Consecutive patients for CLE examination

    Procedure: CLE examination for upper gastrointestinal tract

Interventions

  • ProcedureCLE examination for upper gastrointestinal tract

    Routine upper GI endoscopy plus targeted CLE examination

    Also known as: confocal endomicroscopy

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What researchers measure

Primary outcomes

  1. Accuracy of black spots in diagnosis of gastric intestinal metaplasia

    Time frame: up to six months

07

Study locations

1 of 1 sites recruiting
  • Department of Gastroenterology, Qilu Hospital, Shandong University
    Jinan, Shandong 250012, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2012, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2012
First posted
Jul 20, 2012
Start
Jun 2012
Primary completionEst.
Dec 2012
CompletionEst.
Dec 2012
Last update
Jul 20, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01646528
Lead sponsor
Shandong University
Responsible party
Yanqing Li (Vice President, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University, Shandong University) — Principal investigator
First posted
Jul 20, 2012
Start date
Jun 2012
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Jul 20, 2012

Study contacts

Yanqing Li, MD, PhD
Contact
liyanqing@sdu.edu.cn
86-531-8216923 ext. 82169508
Yanqing Li, MD, PhD
study director · Department of Gastroenterology, Qilu Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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