Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer

NCT02799420 | Completed

• 1 other identifier: 4-2016-0257
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.

Conditions

Undifferentiated Gastric Cancer

Keywords

confocal laser endomicroscopy; undifferentiated gastric cancer; target biopsy

Outcome Measures

Primary Outcomes (1)

• The percentage of cancer cells in biopsy samples

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

  Day 3

Secondary Outcomes (1)

• The expression ratio of tumor marker in biopsy samples

  Day 3

Study Arms (2)

pCLE group

EXPERIMENTAL

The intervention group

Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France

WLE group

ACTIVE COMPARATOR

The control group

Device: white light endoscopy (WLE)

Interventions

GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France DEVICE

The patients who enrolled the pCLE group will undergo endoscopic biopsy using pCLE. The cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy was done at the most suspicious parts of the cancerous lesion.

pCLE group

white light endoscopy (WLE) DEVICE

The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy

WLE group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery

You may not qualify if:

• A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei university of medical center

Seoul, 03722, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 14, 2016
• Study Start: June 20, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)