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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03449966
Other study ID # 4-2017-0770
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2018
Est. completion date October 2019

Study information

Verified date January 2019
Source Yonsei University
Contact Sang Kil Lee, MD
Phone 82-2-2228-1996
Email sklee@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design


Intervention

Device:
Confocal group
Under pCLE, target biopsy at cancer lesion will be done. 5 pieces of forcep biopsy will be obtained.
Control group
Random biopsy around cancer lesion will be done under WLE. 5 pieces with forcep biopsy will be obtained.

Locations

Country Name City State
Korea, Republic of Yonsei university of medical center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percentage of remnant cancer cells in biopsy samples 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 within the first day after pCLE
Secondary pCLE findings of residual cancer cells after chemotherapy 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…) within the first day after pCLE
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