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Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

This study is not yet open for participant recruitment.
Verified July 2012 by Shandong University
Sponsor:
Collaborators:
Prince of Wales Hospital, Shatin, Hong Kong
National University Hospital, Singapore
The University of New South Wales
Information provided by (Responsible Party):
Yanqing Li, Shandong University
ClinicalTrials.gov Identifier:
NCT01642797
First received: July 11, 2012
Last updated: July 17, 2012
Last verified: July 2012
History of Changes

July 11, 2012
July 17, 2012
August 2012
August 2013   (final data collection date for primary outcome measure)
number of participant with gastric IM/IN/CA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01642797 on ClinicalTrials.gov Archive Site
number of biopsies needed per patient [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/CA without the loss of corresponding diagnostic yield.
Same as current
Not Provided
Not Provided
 
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial

i. To determine whether Confocal Laser Endomicroscopy (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.

ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.

iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Gastric Intestinal Metaplasia
  • Gastric Intraepithelial Neoplasia
  • Gastric Carcinoma
  • Device: Confocal laser endomicroscopy (Pentax, EG3870K)
    Confocal laser endomicroscopy with Targeted Biopsy
  • Device: Standard White-light endoscopy (Pentax, 90i)
    Standard White-light endoscopy with Standard Biopsy
  • Experimental: CLE-TB
    Confocal laser endomicroscopy with Targeted Biopsy
    Intervention: Device: Confocal laser endomicroscopy (Pentax, EG3870K)
  • Experimental: WLE-SB
    Standard White-light endoscopy with Standard Biopsy
    Intervention: Device: Standard White-light endoscopy (Pentax, 90i)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
242
September 2013
August 2013   (final data collection date for primary outcome measure)

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 sodium
  • Inability to provide informed consent and other situations that could interfere with the examination protocol
Both
18 Years to 80 Years
No
Contact: Yanqing Li, PhD. MD. 86-531-8216923 ext 82169508 qiluliyanqign@gmail.com
Australia,   China,   Singapore
 
NCT01642797
20120621
Yes
Yanqing Li, Shandong University
Shandong University
  • Prince of Wales Hospital, Shatin, Hong Kong
  • National University Hospital, Singapore
  • The University of New South Wales
Not Provided
Shandong University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP