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

Not Applicable

• Conditions: Lower Gastrointestinal Disorders
• Interventions: Procedure: probe-based confocal laser endomicroscopy

• Registration Number: NCT02091895
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-16
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-19
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

• Adults over 20 years old
• Patients with colorectal polyps
• Patients who undergo endoscopic submucosal dissection (ESD) due to lateral spreading tumors or early colorectal cancer
• Patients with submucosal tumor in colorectal cancer
• Patients with ileocecal ulcers
• Patients who consented to research

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Exclusion Criteria

• Patients who are impossible to biopsy or polypectomy due to underlying diseases.
• Patients who are not able to end the ESD because of a complication
• Patients who are already known the cause of ileocecal ulcers before the pCLE.
• Patients with contraindications to the use of disease fluorescent contrast agents
• Patients who did not consent to research
• Patients who are unsuitable for clinical trials in charge of the attending physician.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endo group	probe-based confocal laser endomicroscopy	colon polyp, early colon cancer, colorectal submucosal tumor, ileocecal ulcers

Primary Outcome Measures

Name	Time	Method
Sensitivity of pCLE diagnosis	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy of pCLE diagnosis	2 weeks	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.
Specificity of pCLE diagnosis	2 weeks	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.
amphoteric predict of pCLE diagnosis	2 weeks	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.

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of