Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2019-10-31

Brief Summary

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\* single center, prospective study First, evaluate the lesion under the white light endoscopy (WLE) → IV fluorescein sodium 0.1mL/kg → evaluate the lesion under probe-based confocal laser microendoscopy → target biopsy under the pCLE → random biopsy under WLE

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Detailed Description

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The purpose of this study is to conduct a study on genetic pathology, obtaining of 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 of patients after chemotherapy is usually 30% or less. Because cancer cells are often replaced with regenerative cells after chemotherapy, even though there are still remnant cancer cells in the stomach. 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 no previous study about precious biopsy method for patients after chemotherapy. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for remnant gastric cancer after chemotherapy will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.

Conditions

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Advanced Gastric Cancer Neoadjuvant Chemotherapy Palliative Chemotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

All procedures were performed with both WLE and pCLE. One patient underwent both WLE and pCLE. Target biopsy under pCLE and random biopsy at cancer lesion under WLE will be done for one patient. The proportion of remnant cancer cells in biopsy samples will be compared.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Target biopsy under pCLE

(Cellvisio® with confocal minoprobe™, Mauna Kea Technologies, France)

Group Type EXPERIMENTAL

Confocal group

Intervention Type DEVICE

Under pCLE, target biopsy at cancer lesion will be done. 5 pieces of forcep biopsy will be obtained.

Random biopsy at cancer lesion under WLE

WLE (GIF-HQ290, Olympus, Japan) group

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type DEVICE

Random biopsy around cancer lesion will be done under WLE. 5 pieces with forcep biopsy will be obtained.

Interventions

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Confocal group

Under pCLE, target biopsy at cancer lesion will be done. 5 pieces of forcep biopsy will be obtained.

Intervention Type DEVICE

Control group

Random biopsy around cancer lesion will be done under WLE. 5 pieces with forcep biopsy will be obtained.

Intervention Type DEVICE

Other Intervention Names

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pCLE group

Eligibility Criteria

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Inclusion Criteria

A. Older than 20 years old and younger than 80 years old B. Patients who completed neoadjuvant chemotherapy with AGC C. Patients who underwent palliative chemotherapy with AGC

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No