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

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.

Study Overview

• Status: Unknown
• Conditions: Lower Gastrointestinal Disorders
• Intervention / Treatment: Procedure: probe-based confocal laser endomicroscopy

• Study Type: Interventional
• Enrollment (Anticipated): 311
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tae Il Kim, MD, PhD; Phone Number: 82-2-2228-1965; Email: taeilkim@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Severance Hospital
    • Contact: Tae Il Kim, MD, PhD; Phone Number: 82-2-2228-1965; Email: taeilkim@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: endo group; colon polyp, early colon cancer, colorectal submucosal tumor, ileocecal ulcers

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of pCLE diagnosis	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of pCLE diagnosis	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.	2 weeks
Accuracy of pCLE diagnosis	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.	2 weeks
amphoteric predict of pCLE diagnosis	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.	2 weeks

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: March 16, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: probe-based confocal laser endomicroscopy, lower gastrointestinal disorders
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 4-2013-0942