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

• Sponsor: Yonsei University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02091895
• Collaborator: (none)
• Enrollment: 311
• Location: 1
• Arm: 1
• Duration (Months): 71.1
• Patients Per Site Per Month: 4.4

Study Details

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.

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 or Disease	Intervention/Treatment	Phase
Lower Gastrointestinal Disorders	Procedure: probe-based confocal laser endomicroscopy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 311 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Mar 1, 2014
• Anticipated Primary Completion Date: Feb 1, 2020
• Anticipated Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02091895
• Other Study ID Numbers: 4-2013-0942
• First Posted: Mar 19, 2014
• Last Update Posted: Mar 13, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Yonsei University: probe-based confocal laser endomicroscopy, lower gastrointestinal disorders
• Additional relevant MeSH terms: Gastrointestinal Diseases; Digestive System Diseases

Study Results

No Results Posted as of Mar 13, 2019