A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy

Yonsei University

Status: Completed

Conditions: Gastric Cancer

Treatments: Procedure: White light endoscopy; Procedure: Probe-based confocal laser endomicroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02089373

4-2013-0392

Details and patient eligibility

About

The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells in biopsy samples.

Enrollment: 30 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age, between 20 and 80
2. Initial-onset gastric cancer which would be treated with surgery

Exclusion criteria

1. Previous subtotal gastrectomy
2. Pregnancy or breast milk feeding
3. Active infection
4. Significant cardiopulmonary disease
5. Active hepatitis or severe hepatic dysfunction
6. Severe renal dysfunction
7. Severe bone marrow dysfunction
8. Severe neurologic or psychotic disorder

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Probe-based confocal laser endomicroscopy

Experimental group

Treatment:

Procedure: Probe-based confocal laser endomicroscopy

White light endoscopy

Active Comparator group

Treatment:

Procedure: White light endoscopy