Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer

Not Applicable

Completed

• Conditions: Undifferentiated Gastric Cancer
• Interventions: Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France; Device: white light endoscopy (WLE)

• Registration Number: NCT02799420
• 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. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-14
• Study Start: 2016-06-20
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

A. Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery

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Exclusion Criteria

A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pCLE group	GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France	The intervention group
WLE group	white light endoscopy (WLE)	The control group

Primary Outcome Measures

Name	Time	Method
The percentage of cancer cells in biopsy samples	Day 3	The percentage of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy

Secondary Outcome Measures

Name	Time	Method
The expression ratio of tumor marker in biopsy samples	Day 3	The expression ratio of tumor marker in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy

Trial Locations

Locations (1)

Yonsei university of medical center; 🇰🇷 Seoul, Korea, Republic of