Know Cancer

forgot password

Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial

18 Years
80 Years
Not Enrolling
Gastric Intestinal Metaplasia, Gastric Intraepithelial Neoplasia, Gastric Carcinoma

Thank you

Trial Information

Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial

Gastric cancer remains the world's second leading cause of cancer-related deaths. The
prognosis for patients with this cancer clearly depends on stage at diagnosis. At least for
the intestinal subtype of gastric adenocarcinoma, a cascade of histopathologic lesions has
been defined: chronic gastritis, atrophic chronic gastritis, intestinal metaplasia (IM), and
intraepithelial neoplasia (IN). The identification of these lesions and follow-up of
patients in whom they are found could lead to diagnosis of gastric cancer at an early stage,
thus improving patients' survival. The diagnosis of these lesions, which often appear in
flat mucosa, is currently based on histopathologic examination of endoscopic biopsy
specimens. However, conventional white-light endoscopy (WLE) for this purpose has high
interobserver variability and a poor correlation with histopathologic finding.

Confocal laser endomicroscopy (CLE), producing both conventional WLE and confocal
microscopic images, can provide a direct histological observation of the in vivo tissue
without the need for biopsy. Recently, CLE has shown its value for diagnosing gastric IM,
intraepithelial neoplasia and carcinoma. However, none of those CLE criteria for gastric IM,
IN or carcinoma (CA) has been validated in various endoscopic centers, hence reducing the
reliability and clinical application of them.

Inclusion Criteria:

- Male or Female aged 18-80

- Patients with H. pylori infection, or histologically verified gastric intestinal
metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis

Exclusion Criteria:

- Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer

- Patients under conditions unsuitable for performing CLE including coagulopathy,
impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein

- Inability to provide informed consent and other situations that could interfere with
the examination protocol

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

number of participant with gastric IM/IN/CA

Outcome Description:

To determine whether CLE with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.

Outcome Time Frame:

1 year

Safety Issue:



China: Ministry of Health

Study ID:




Start Date:

August 2012

Completion Date:

September 2013

Related Keywords:

  • Gastric Intestinal Metaplasia
  • Gastric Intraepithelial Neoplasia
  • Gastric Carcinoma
  • confocal laser endomicroscopy
  • gastric intestinal metaplasia
  • gastric intraepithelial neoplasia
  • gastric carcinoma
  • Neoplasms
  • Carcinoma
  • Stomach Neoplasms
  • Metaplasia
  • Gastritis, Atrophic
  • Carcinoma in Situ