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A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Probe-based confocal laser endomicroscopy
White light endoscopy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age, between 20 and 80
  2. Initial-onset gastric cancer which would be treated with surgery

Exclusion Criteria:

  1. Previous subtotal gastrectomy
  2. Pregnancy or breast milk feeding
  3. Active infection
  4. Significant cardiopulmonary disease
  5. Active hepatitis or severe hepatic dysfunction
  6. Severe renal dysfunction
  7. Severe bone marrow dysfunction
  8. Severe neurologic or psychotic disorder

Sites / Locations

  • Institutional Review Board in Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Probe-based confocal laser endomicroscopy

White light endoscopy

Arm Description

Outcomes

Primary Outcome Measures

The percentage of cancer cells in biopsy samples
The percentages of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endosocpy

Secondary Outcome Measures

Full Information

First Posted
March 13, 2014
Last Updated
August 19, 2015
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02089373
Brief Title
A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to conduct a study on genetic pathology, obtaining of pure 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 is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells in biopsy samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probe-based confocal laser endomicroscopy
Arm Type
Experimental
Arm Title
White light endoscopy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Probe-based confocal laser endomicroscopy
Intervention Description
In this arm1, an investigator observes a cancerous lesion using white light endoscopy. In addition, contrast dye for confocal laser endomicorscopy (fluorescein sodium 0.1mL/kg) is administered. Then, the cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy would be done 5 times at the most suspcious parts of the cancerous lesion.
Intervention Type
Procedure
Intervention Name(s)
White light endoscopy
Intervention Description
In this arm2, an invesigator observes a cancerous lesion using white light endoscopy. The biopsy would be done 5 times at the most suspicious parts of the cancerous lesion.
Primary Outcome Measure Information:
Title
The percentage of cancer cells in biopsy samples
Description
The percentages of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endosocpy
Time Frame
After 3 days from the end of the endoscopic submucosal dissection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age, between 20 and 80 Initial-onset gastric cancer which would be treated with surgery Exclusion Criteria: Previous subtotal gastrectomy Pregnancy or breast milk feeding Active infection Significant cardiopulmonary disease Active hepatitis or severe hepatic dysfunction Severe renal dysfunction Severe bone marrow dysfunction Severe neurologic or psychotic disorder
Facility Information:
Facility Name
Institutional Review Board in Severance Hospital
City
Seodaemun-gu
State/Province
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy

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