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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Shandong University.
Recruitment status was  Not yet recruiting
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
  Purpose

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.


Condition Intervention
Gastric Intestinal Metaplasia
Gastric Intraepithelial Neoplasia
Gastric Carcinoma
Device: Confocal laser endomicroscopy (Pentax, EG3870K)
Device: Standard White-light endoscopy (Pentax, 90i)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 242
Study Start Date: August 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLE-TB
Confocal laser endomicroscopy with Targeted Biopsy
Device: Confocal laser endomicroscopy (Pentax, EG3870K)
Confocal laser endomicroscopy with Targeted Biopsy
Experimental: WLE-SB
Standard White-light endoscopy with Standard Biopsy
Device: Standard White-light endoscopy (Pentax, 90i)
Standard White-light endoscopy with Standard Biopsy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642797

Contacts
Contact: Yanqing Li, PhD. MD. 86-531-8216923 ext 82169508 qiluliyanqign@gmail.com

Locations
Australia
the University of New South Wales, Bankstown-Lidcombe Hospital Not yet recruiting
Bankstown, Australia
Contact: Rupert W. L. Leong, MD. PhD.         
Principal Investigator: Rupert W Leong, MD. PhD.         
China, Hongkong
the Prince of Wales Hospital, Chinese University of Hong Kong Not yet recruiting
Hongkong, Hongkong, China
Contact: Joseph Jao-Yiu Sung, MD. PhD.         
Principal Investigator: Joseph Jao-Yiu Sung, MD. PhD.         
China, Shandong
Qilu Hospital, Shandong University Not yet recruiting
Jinan, Shandong, China, 20012
Principal Investigator: Yanqing Li, MD. PhD.         
Singapore
National University Hospital, National University of Singapore Not yet recruiting
Singapore, Singapore
Contact: Ho Khek Yu, MD. PhD.         
Principal Investigator: Ho Khek Yu, MD. PhD.         
Sponsors and Collaborators
Shandong University
Prince of Wales Hospital, Shatin, Hong Kong
National University Hospital, Singapore
The University of New South Wales
  More Information

No publications provided

Responsible Party: Yanqing Li, Chief of the department of Gastroenterology, Shandong University
ClinicalTrials.gov Identifier: NCT01642797     History of Changes
Other Study ID Numbers: 20120621
Study First Received: July 11, 2012
Last Updated: July 17, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
confocal laser endomicroscopy
gastric intestinal metaplasia
gastric intraepithelial neoplasia
gastric carcinoma

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Stomach Neoplasms
Metaplasia
Gastritis, Atrophic
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathologic Processes
Gastritis
Gastroenteritis

ClinicalTrials.gov processed this record on August 21, 2014