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

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Probe-based confocal laser endomicroscopy; Procedure: White light endoscopy

• Registration Number: NCT02089373
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probe-based confocal laser endomicroscopy	Probe-based confocal laser endomicroscopy	-
White light endoscopy	White light endoscopy	-

Primary Outcome Measures

Name	Time	Method
The percentage of cancer cells in biopsy samples	After 3 days from the end of the endoscopic submucosal dissection	The percentages of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endosocpy

Trial Locations

Locations (1)

Institutional Review Board in Severance Hospital; 🇰🇷 Seodaemun-gu, Seoul, Korea, Republic of