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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02091895
First received: March 16, 2014
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Lower Gastrointestinal Disorders
Procedure: probe-based confocal laser endomicroscopy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Sensitivity of pCLE diagnosis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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:
  • Specificity of pCLE diagnosis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Accuracy of pCLE diagnosis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 311
Study Start Date: March 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02091895

Contacts
Contact: Tae Il Kim, MD, PhD 82-2-2228-1965 taeilkim@yuhs.ac

Locations
Korea, Republic of
Severance hospital Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Tae Il Kim, MD, PhD    82-2-2228-1965    taeilkim@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02091895     History of Changes
Other Study ID Numbers: 4-2013-0942
Study First Received: March 16, 2014
Last Updated: March 17, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
probe-based confocal laser endomicroscopy, lower gastrointestinal disorders

Additional relevant MeSH terms:
Disease
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014