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

Not Applicable

• Conditions: Palliative Chemotherapy; Advanced Gastric Cancer; Neoadjuvant Chemotherapy
• Interventions: Device: Confocal group; Device: Control group

• Registration Number: NCT03449966
• Lead Sponsor: Yonsei University

Brief Summary

\* 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

Detailed Description

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.

Study Timeline

• Study Start: 2018-02-20
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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

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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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Target biopsy under pCLE	Confocal group	(Cellvisio® with confocal minoprobe™, Mauna Kea Technologies, France)
Random biopsy at cancer lesion under WLE	Control group	WLE (GIF-HQ290, Olympus, Japan) group

Primary Outcome Measures

Name	Time	Method
The percentage of remnant cancer cells in biopsy samples	within the first day after pCLE	The percentage of remnant 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
pCLE findings of residual cancer cells after chemotherapy	within the first day after pCLE	The specific findins of remnant cancer cells under probe-based confocal laser endomicroscopy (ex. Destruction of gland structure, increased numbers of blood vessel, dark cells...)

Trial Locations

Locations (1)

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