PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

Diagnostic Yield of Gastric Neoplasia Clinical Trial

— PCLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02515721
• Other study ID #: 2015SDU-QILU-G06
• Status: Recruiting
• Phase: N/A
• First received: August 3, 2015
• Last updated: August 3, 2015
• Start date: July 2014

Study information

• Verified date: August 2015
• Source: Shandong University
• Contact: Li Yanqing, PhD, MD
• Phone: 053182169385
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: the Ministry of Health of China':'
• Study type: Interventional

Clinical Trial Summary

Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• aged between 18 and 80;

• patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia;

• agree to give written informed consent.

Exclusion Criteria:

• Patients with gastrectomy, acute GI bleeding, and known gastric neoplasia;

• Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;

• Inability to provide informed consent

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 in Situ
• Diagnostic Yield of Gastric Neoplasia
• Gastritis, Atrophic
• Metaplasia
• Neoplasms

Intervention

Device:
• pCLE-TB
Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.
• virtual chromoendoscopy-TB
Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.

Locations

Country	Name	City	State
China	Endoscopic unit of Qilu Hospital Shandong University	Jinan	Shandong

Sponsors (4)

Lead Sponsor	Collaborator
Shandong University	Tongji Hospital, Wuhan Union Hospital, China, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer		12 months	No
Secondary	the biopsy number needed for diagnosis		12 months	No