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

NCT ID: NCT02089373

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Probe-based confocal laser endomicroscopy

Group Type: EXPERIMENTAL

Probe-based confocal laser endomicroscopy

Intervention Type: PROCEDURE

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.

White light endoscopy

Group Type: ACTIVE_COMPARATOR

White light endoscopy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institutional Review Board in Severance Hospital

Seodaemun-gu, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2013-0392

Identifier Type: -

Identifier Source: org_study_id