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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089373
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Probe-based confocal laser endomicroscopy Procedure: White light endoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Probe-based confocal laser endomicroscopy Procedure: Probe-based confocal laser endomicroscopy
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.
Active Comparator: White light endoscopy Procedure: White light endoscopy
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.


Outcome Measures
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Primary Outcome Measures :
  1. The percentage of cancer cells in biopsy samples [ Time Frame: After 3 days from the end of the endoscopic submucosal dissection ]
    The percentages of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endosocpy


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089373


Locations
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Korea, Republic of
Institutional Review Board in Severance Hospital
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02089373    
Other Study ID Numbers: 4-2013-0392
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases