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

Sponsor
Yonsei University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03449966
Collaborator
(none)
55
Enrollment
1
Location
2
Arms
19.3
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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
Condition or Disease Intervention/Treatment Phase
  • Device: Confocal group
  • Device: Control group
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status
Actual Study Start Date :
Feb 20, 2018
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Target biopsy under pCLE

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

Device: Confocal group
Under pCLE, target biopsy at cancer lesion will be done. 5 pieces of forcep biopsy will be obtained.
Other Names:
  • pCLE group

    		•
    Active Comparator: Random biopsy at cancer lesion under WLE

    WLE (GIF-HQ290, Olympus, Japan) group

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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…)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. 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:
    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei university of medical center Seoul Korea, Republic of 03722

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT03449966
    Other Study ID Numbers:
    • 4-2017-0770
    First Posted:
    Feb 28, 2018
    Last Update Posted:
    Jan 11, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yonsei University
    pCLE
    confocal
    Advanced gastric cancer
    chemotherapy
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Jan 11, 2019