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

NCT02091895 | Unknown

• 1 other identifier: 4-2013-0942
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

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

Conditions

Lower Gastrointestinal Disorders

Keywords

probe-based confocal laser endomicroscopy, lower gastrointestinal disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Specificity of pCLE diagnosis

  2 weeks

• Accuracy of pCLE diagnosis

  2 weeks

• amphoteric predict of pCLE diagnosis

  2 weeks

Study Arms (1)

endo group

EXPERIMENTAL

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

Procedure: probe-based confocal laser endomicroscopy

Interventions

probe-based confocal laser endomicroscopy 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.

endo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

RECRUITING

Central Study Contacts

Tae Il Kim, MD, PhD

CONTACT

82-2-2228-1965; taeilkim@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2014
• First Posted: March 19, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

KR (1)