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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02799420

Collaborator

(none)

Enrollment

Location

Arms

14.4

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Undifferentiated Gastric Cancer	Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France Device: white light endoscopy (WLE)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Actual Study Start Date :

Jun 20, 2016

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pCLE group The intervention group	Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France 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.
Active Comparator: WLE group The control group	Device: white light endoscopy (WLE) The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy

Arm

Intervention/Treatment

Experimental: pCLE group

The intervention group

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

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.

Active Comparator: WLE group

The control group

Device: white light endoscopy (WLE)

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

Outcome Measures

Primary Outcome Measures

The percentage of cancer cells in biopsy samples [Day 3]
The percentage of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy

Secondary Outcome Measures

The expression ratio of tumor marker in biopsy samples [Day 3]
The expression ratio of tumor marker in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei university of medical center	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT02799420

Other Study ID Numbers:

4-2016-0257

First Posted:

Jun 14, 2016

Last Update Posted:

Oct 24, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Yonsei University

confocal laser endomicroscopy

undifferentiated gastric cancer

target biopsy

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Oct 24, 2017