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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02932735
Enrollment
30
Registered
2016-10-13
Start date
2016-10-31
Completion date
2017-06-30
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
the sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).6 months
the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM).6 months

Secondary

MeasureTime frame
the of sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).6 months
the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM).6 months

Contacts

Primary ContactLi Yanqing, MD, PhD
liyanqing@sdu.edu.cn86-531-82169236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026