Lower Gastrointestinal DisordersNCT02091895
Validation of Clinical Efficacy and Development of New Diagnostic Algorithm of Probe-based Confocal Laser Endomicroscopy in Patients With Lower Gastrointestinal Disorder
A study testing probe-based confocal laser endomicroscopy in people with Lower Gastrointestinal Disorders, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lower Gastrointestinal Disorders
- What is being tested?
- probe-based confocal laser endomicroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul, 120-752
Tae Il Kim, MD, PhD, 82-2-2228-1965, taeilkim@yuhs.ac
About this study
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.
Read more
- 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.
- Conditions
- Lower Gastrointestinal Disorders
- Being tested
- probe-based confocal laser endomicroscopy
- Keywords
- probe-based confocal laser endomicroscopy, lower gastrointestinal disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probe-based confocal laser endomicroscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| endo group | Experimental | colon polyp, early colon cancer, colorectal submucosal tumor, ileocecal ulcers Receives: Procedure: probe-based confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (3)
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 311 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091895
- Sponsor's protocol ID
- 4-2013-0942
- Status last verified
- Mar 2019
- First submitted
- 16 Mar 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clinical Efficacy and Development of New Diagnostic Algorithm of Probe-based Confocal Laser Endomicroscopy in Patients With Lower Gastrointestinal Disorder
- ClinicalTrials.gov ID
- NCT02091895
- Acronym / sponsor ID
- 4-2013-0942
- Conditions
- Lower Gastrointestinal Disorders
- Keywords
- probe-based confocal laser endomicroscopy, lower gastrointestinal disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 311 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endo group | Experimental | Procedure: probe-based confocal laser endomicroscopycolon polyp, early colon cancer, colorectal submucosal tumor, ileocecal ulcers |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probe-based confocal laser endomicroscopyAfter 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. | Procedure or surgery | endo group |
Primary outcome
Sensitivity of pCLE diagnosis
Time frame: 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 secondary outcomes
Specificity of pCLE diagnosis
Time frame: 2 weeks
Accuracy of pCLE diagnosis
Time frame: 2 weeks
amphoteric predict of pCLE diagnosis
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probe-based confocal laser endomicroscopy in people with Lower Gastrointestinal Disorders, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae Il Kim, MD, PhD (82-2-2228-1965, taeilkim@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of pCLE diagnosis (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.