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

October 23, 2017 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of cancer cells in biopsy samples
Time Frame: 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
Day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The expression ratio of tumor marker in biopsy samples
Time Frame: 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
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-0257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no plan to share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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