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

NCT ID: NCT02091895

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2020-02-29

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.

Conditions

Lower Gastrointestinal Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

endo group

colon polyp, early colon cancer, colorectal submucosal tumor, ileocecal ulcers

Group Type: EXPERIMENTAL

probe-based confocal laser endomicroscopy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Tae Il Kim, MD, PhD

Role: CONTACT

taeilkim@yuhs.ac

82-2-2228-1965

Facility Contacts

Tae Il Kim, MD, PhD

Role: primary

taeilkim@yuhs.ac

82-2-2228-1965

Other Identifiers

4-2013-0942

Identifier Type: -

Identifier Source: org_study_id