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Validation of Clinical Efficacy and Development of New Diagnostic Algorithm of Probe-based Confocal Laser Endomicroscopy in Patients With Lower Gastrointestinal Disorder

NCT02091895 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2019-03-13

No results posted yet for this study

Summary

The aims of this research are to validate and develop of therapeutic strategies for patients with colorectal lesions in real time through pCLE(probe-based confocal laser endomicroscopy). Endomicroscopy is a technique for obtaining histology-like images from inside the human body in real-time. Total objections are 311 patients.

Specific research topics are as below.

1. Diagnosis and classification of colon polyps through pCLE
2. Evaluation of the depth of invasion of colorectal cancer or lateral growth type tumor through the pCLE
3. Differential diagnosis of colorectal submucosal tumor through the pCLE
4. Differential diagnosis of ileocecal ulcers through the pCLE

The study will be conducted to measure sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions Check diagnostic agreement of technical phrases which are derived, the matching degree between observers, and will develope a new classification method based on this.

Conditions

  • Lower Gastrointestinal Disorders

Interventions

PROCEDURE

probe-based confocal laser endomicroscopy

After shooting 10% fluorescein sodium in,2.5-5 .0 ml to the object with colorectal disease, the lesion will observed and evaluated with pCLE in real-time and also stored the inspection images. Then, determines the treatment plan to determine which is applied currently in clinical, Sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions Based on the inspection image stored, using Delphi approach tests, two or more are discussed, to derive a significant technical phrases. Check diagnostic agreement of technical phrases which are derived, the matching degree between observers, and developed a new classification method based on this.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02091895 on ClinicalTrials.gov