Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia (pCLE)

September 19, 2012 updated by: Gene Hyun Bok, Soonchunhyang University Hospital

The Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias

Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are limited data exploring the application of pCLE to gastric lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the final specimens obtained from endoscopic resection as a reference standard. The aims of this study were (1) the accuracy of pCLE compared to conventional forceps biopsy using histopathology results following endoscopic resection as a reference, and (2) comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis, and off-line interobserver agreement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 140-743
        • SoonChunHyang University Seoul Hospital

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients referred to a tertiary medical center for endoscopic resection of gastric superficial lesions.

Description

Inclusion Criteria:

  • Patients with biospy proven superficial gastric neoplasia, suitable for endoscopic resection.

Exclusion Criteria:

  • Patients with uncorrectable coagulopathy,
  • liver cirrhosis,
  • acute gastrointestinal bleeding,
  • pregnancy,
  • breast feeding,
  • documented allergy to fluorescein,
  • patients with lesions that were deemed unsuitable for endoscopic resection, and
  • patients without documented conventional biopsy results.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Superficial gastric neoplasia
Patients with superficial gastric neoplasia on diagnostic endoscopy, recieved both conventional endoscopic forcpes biopsies and pCLE. All patients were subject to endoscopic resection of the lesion.
Procedure: Endoscopic submucosal dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of pCLE compared to conventional forceps biopsy
Time Frame: in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.
The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference
in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis.
Time Frame: 1-3 months after endoscopic resection and final histopathological analysis
1-3 months after endoscopic resection and final histopathological analysis
Off-line pCLE interobserver agreement
Time Frame: 1-3 months after endoscopic resection and final histopathological analysis
1-3 months after endoscopic resection and final histopathological analysis

Collaborators and Investigators

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

Sponsor

Soonchunhyang University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 6, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 20, 2012

Study Record Updates

Last Update Posted (Estimate)

September 20, 2012

Last Update Submitted That Met QC Criteria

September 19, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-2012-01

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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