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

Primary Purpose

Lower Gastrointestinal Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
probe-based confocal laser endomicroscopy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lower Gastrointestinal Disorders focused on measuring probe-based confocal laser endomicroscopy, lower gastrointestinal disorders

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Severance hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endo group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 16, 2014
Last Updated
March 12, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02091895
Brief Title
Validation of Clinical Efficacy and Development of New Diagnostic Algorithm of Probe-based Confocal Laser Endomicroscopy in Patients With Lower Gastrointestinal Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. Diagnosis and classification of colon polyps through pCLE Evaluation of the depth of invasion of colorectal cancer or lateral growth type tumor through the pCLE Differential diagnosis of colorectal submucosal tumor through the pCLE 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Gastrointestinal Disorders
Keywords
probe-based confocal laser endomicroscopy, lower gastrointestinal disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
311 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endo group
Arm Type
Experimental
Arm Description
colon polyp, early colon cancer, colorectal submucosal tumor, ileocecal ulcers
Intervention Type
Procedure
Intervention Name(s)
probe-based confocal laser endomicroscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of pCLE diagnosis
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Specificity of pCLE diagnosis
Description
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.
Time Frame
2 weeks
Title
Accuracy of pCLE diagnosis
Description
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.
Time Frame
2 weeks
Title
amphoteric predict of pCLE diagnosis
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae Il Kim, MD, PhD
Phone
82-2-2228-1965
Email
taeilkim@yuhs.ac
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Il Kim, MD, PhD
Phone
82-2-2228-1965
Email
taeilkim@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

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

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