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

Phase 4

• Conditions: Gastric Intestinal Metaplasia; Biopsy; Confocal Laser Endomicroscopy; Operative Link on Gastric Intestinal Metaplasia
• Interventions: Device: Patients in Group 1 will receive pCLE at first and WLE 2 months later; Device: patients in Group 2 will receive WLE at first and pCLE 2 months later.

• Registration Number: NCT02930616
• Lead Sponsor: Shandong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-11
• Last Update Submitted: 2016-10-11
• Study First Posted: 2016-10-12
• Last Update Posted: 2016-10-12
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.	9 months
the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE.	9 months

Secondary Outcome Measures

Name	Time	Method
the overall detection rate of GIM by WLE.	9 months
the overall detection rate of GIM by pCLE.	9 months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China