The Efficacy of Probe-based Confocal Laser Endomicroscopy in Staging OLGIM

NCT ID: NCT02932735

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-06-30

Brief Summary

Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.

Conditions

Probe-based Confocal Laser Endomicroscopy; the Operative Link on Gastric Intestinal Metaplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients aged 40 years or older with Helicobacter pylori infection;
• Histologically verified GIM, atrophic gastritis or dysplasia.

Exclusion Criteria

• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
• Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;
• Pregnancy or breastfeeding;
• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Vice president of Qilu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Yanqing, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Central Contacts

Li Yanqing, MD, PhD

Role: CONTACT

liyanqing@sdu.edu.cn

86-531-82169236

Other Identifiers

2016SDU-QILU-18

Identifier Type: -

Identifier Source: org_study_id