Lower Gastrointestinal Disorders
Conditions
Keywords
probe-based confocal laser endomicroscopy, lower gastrointestinal disorders
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.
Interventions
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.
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of pCLE diagnosis | 2 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Specificity of pCLE diagnosis | 2 weeks | 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 | 2 weeks | 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 | 2 weeks | 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. |
Countries
South Korea
Contacts
Primary ContactTae Il Kim, MD, PhD
Outcome results
None listed