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

Gastric Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01642797
• Other study ID #: 20120621
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Gastric Carcinoma
• Gastric Intestinal Metaplasia
• Gastric Intraepithelial Neoplasia
• Gastritis, Atrophic
• Metaplasia
• Neoplasms
• Stomach Neoplasms

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