Clinical trial NCT03449966: Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status
Official title: Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Gastric Cancer
Neoadjuvant Chemotherapy
Palliative Chemotherapy
Keywords: pCLE
confocal
Advanced gastric cancer
chemotherapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of remnant cancer cells in biopsy samples
timeFrame: within the first day after pCLE
Secondary outcomes:
measure: pCLE findings of residual cancer cells after chemotherapy
timeFrame: within the first day after pCLE
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university of medical center
Study officials:
References: