A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Gastric Intestinal Metaplasia; Biopsy; Confocal Laser Endomicroscopy; Operative Link on Gastric Intestinal Metaplasia

Treatments: Device: patients in Group 2 will receive WLE at first and pCLE 2 months later.; Device: Patients in Group 1 will receive pCLE at first and WLE 2 months later

Study type: Interventional

Funder types: Other

Identifiers

NCT02930616

2016SDU-QILU-17

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

group 1

Experimental group

Description:

Patients in Group 1 will receive probe-based confocal endomicroscopy (pCLE) at first and Wight light endoscopy (WLE) 2 months later

Treatment:

Device: Patients in Group 1 will receive pCLE at first and WLE 2 months later

goup 2

Active Comparator group

Description:

patients in Group 2 will receive WLE at first and pCLE 2 months later.

Treatment:

Device: patients in Group 2 will receive WLE at first and pCLE 2 months later.