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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02089373

Enrollment

Registered

2014-03-17

Start date

2014-03-31

Completion date

2015-03-31

Last updated

2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

PROCEDUREProbe-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.

PROCEDUREWhite 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The percentage of cancer cells in biopsy samples	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026