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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01642797
Other study ID # 20120621
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 11, 2012
Last updated July 17, 2012
Start date August 2012
Est. completion date September 2013

Study information

Verified date July 2012
Source Shandong University
Contact Yanqing Li, PhD. MD.
Phone 86-531-8216923
Email qiluliyanqign@gmail.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 242
Est. completion date September 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

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


Intervention

Device:
Confocal laser endomicroscopy (Pentax, EG3870K)
Confocal laser endomicroscopy with Targeted Biopsy
Standard White-light endoscopy (Pentax, 90i)
Standard White-light endoscopy with Standard Biopsy

Locations

Country Name City State
Australia the University of New South Wales, Bankstown-Lidcombe Hospital Bankstown
China the Prince of Wales Hospital, Chinese University of Hong Kong Hongkong Hongkong
China Qilu Hospital, Shandong University Jinan Shandong
Singapore National University Hospital, National University of Singapore Singapore

Sponsors (4)

Lead Sponsor Collaborator
Shandong University National University Hospital, Singapore, Prince of Wales Hospital, Shatin, Hong Kong, The University of New South Wales

Countries where clinical trial is conducted

Australia,  China,  Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of participant with gastric IM/IN/CA 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. 1 year No
Secondary number of biopsies needed per patient 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. 1 year No
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