A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy
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ClinicalTrials.gov Identifier: NCT02089373 |
Recruitment Status :
Completed
First Posted : March 17, 2014
Last Update Posted : August 21, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Procedure: Probe-based confocal laser endomicroscopy Procedure: White light endoscopy | Not Applicable |
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 |

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. |
- 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

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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 |
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

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
Korea, Republic of | |
Institutional Review Board in Severance Hospital | |
Seodaemun-gu, Seoul, Korea, Republic of, 120-752 |
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 |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |