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

Gastric Intestinal Metaplasia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02930616
• Other study ID #: 2016SDU-QILU-17
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 10, 2016
• Last updated: October 11, 2016
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: Shandong University
• Contact: Li Yanqing, MD, PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Biopsy
• Confocal Laser Endomicroscopy
• Gastric Intestinal Metaplasia
• Metaplasia
• Operative Link on Gastric Intestinal Metaplasia

Intervention

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

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

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.		9 months	No
Primary	the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE.		9 months	No
Secondary	the overall detection rate of GIM by pCLE.		9 months	No
Secondary	the overall detection rate of GIM by WLE.		9 months	No