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

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Yonsei University

Status

Completed

Conditions

Undifferentiated Gastric Cancer

Treatments

Device: white light endoscopy (WLE)
Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France

Study type

Interventional

Funder types

Other

Identifiers

NCT02799420
4-2016-0257

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. 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.

Enrollment

74 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

pCLE group
Experimental group
Description:
The intervention group
Treatment:
Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France
WLE group
Active Comparator group
Description:
The control group
Treatment:
Device: white light endoscopy (WLE)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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