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

Lower Gastrointestinal Disorders Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02091895
• Other study ID #: 4-2013-0942
• Status: Recruiting
• Phase: N/A
• Start date: March 2014
• Est. completion date: February 2020

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: Tae Il Kim, MD, PhD
• Phone: 82-2-2228-1965
• Email: taeilkim[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 311
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Lower Gastrointestinal Disorders

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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