Colorectal PolypsNCT02033980
Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions
A study testing NBI in people with Colorectal Polyps, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Recently, a new category classification (NICE classification) using non-magnified NBI has been proposed. We design this multicenter study to evaluate the reliability and validity of the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both image and real-time process. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- NBI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Aug 2017
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with colorectal lesions during colonoscopy examination
- Informed consent available
Who cannot join
- Suspect of advanced colorectal cancer
- History of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
- Poor bowel preparation
- Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200001
Zhizheng Ge, MD, Ph.D
About this study
Official title: Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China
Recently, a new category classification (NICE classification) using non-magnified NBI has been proposed. We design this multicenter study to evaluate the reliability and validity of the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both image and real-time process.
Read the detailed description
Many reports have demonstrated the efficacy of narrow band imaging (NBI) with magnification in predicting the histology and invasion depth of colorectal polyps. In China, however, the magnifying endoscope is not used in some medical centers. Even in centers equipped with this technique, the magnifying colonoscope is not sufficiently used in daily practice. Recently, a simple category classification (NICE classification) using non-magnified NBI has been proposed, which classifies colorectal tumors into types 1-3 based on different characteristics of color, surface pattern, and microvessels. Type-1 is considered an index for hyperplastic lesions, type-2 is an index for adenoma or mucosal/SM scanty invasive carcinoma and type-3 is an index for deep SM invasive carcinoma. The new classification has soon arouse attention and been validated in some centers on the efficacy of differentiating adenomatous and hyperplastic polyps. However, most studies enrolled diminutive polyps less than 5mm and the efficacy of non-magnified NBI in differentiating type-2 and type-3 lesions has not been reported. To promote this simple classification, we design this multicenter study to evaluate the predictive validity and performance characteristics of the non-magnified NBI in diagnosing polyps during both image and real-time process.
- Conditions
- Colorectal Polyps
- Being tested
- NBI
- Keywords
- narrow band imaging(NBI), NICE classification, colorectal lesions, predicting histology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBIDevice
Also called Evis Lucera system (CV-260, Olympus Inc, Japan), high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan), magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)
All detected colorectal lesions will be examined by high-definition NBI. For type 2 and type 3 lesions, subsequent magnifying NBI examination will be performed.
| Study group | Role | What they receive |
|---|---|---|
| colorectal lesions | Other | All lesions will be observed with NBI and removed endoscopically or surgically for histological diagnosis. Receives: Device: NBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of NICE classification in histological prediction by gastroenterological fellows
Diagnostic accuracy of gastroenterological fellows using non-magnified NBI according to NICE classification in histological prediction of polyps, compared with histologic examination
Measured: within two weeks after polypectomy
Secondary outcomes (1)
Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions.
For lesions identified as type 2 or type 3, subsequent magnifying NBI examination will be performed by NBI experts. Before that, experts will make their own assessment according to all the images taken by gastroenterological fellows, blind to their diagnosis. Then experts will examine the lesions using magnifying endoscopy with NBI capability and make a new assessment.
Measured: two weeks after endoscopical or surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startMay 2016
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Peking University People's Hospital, Peking Union Medical College Hospital, Chinese PLA General Hospital
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhizheng Ge, MD,Ph.D, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai ,China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033980
- Sponsor's protocol ID
- rjxh[2013]125
- Status last verified
- May 2016
- First submitted
- 27 Dec 2013
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zhang QW, Zhang JJ, Yang AM, Sheng JQ, Liu YL, Li ZS, Chen HY, Feng N, Jiang QW, Jin P, Zhang LM, Fu HY, Gao YJ, Ge ZZ, Li XB. Feasibility of using narrow band imaging international colorectal endoscopic classification for diagnosing colorectal neoplasia in China: A multicenter pilot observational study. J Dig Dis. 2020 Feb;21(2):88-97. doi: 10.1111/1751-2980.12841.
PubMed 31895484
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China
- ClinicalTrials.gov ID
- NCT02033980
- Acronym / sponsor ID
- rjxh[2013]125
- Conditions
- Colorectal Polyps
- Keywords
- narrow band imaging(NBI), NICE classification, colorectal lesions, predicting histology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Changhai Hospital, Peking University People's Hospital, Peking Union Medical College Hospital, Chinese PLA General Hospital
- Study start
- May 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 13 Jan 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.
Recently, a new category classification (NICE classification) using non-magnified NBI has been proposed. We design this multicenter study to evaluate the reliability and validity of the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both image and real-time process.
Detailed description
Many reports have demonstrated the efficacy of narrow band imaging (NBI) with magnification in predicting the histology and invasion depth of colorectal polyps. In China, however, the magnifying endoscope is not used in some medical centers. Even in centers equipped with this technique, the magnifying colonoscope is not sufficiently used in daily practice. Recently, a simple category classification (NICE classification) using non-magnified NBI has been proposed, which classifies colorectal tumors into types 1-3 based on different characteristics of color, surface pattern, and microvessels. Type-1 is considered an index for hyperplastic lesions, type-2 is an index for adenoma or mucosal/SM scanty invasive carcinoma and type-3 is an index for deep SM invasive carcinoma. The new classification has soon arouse attention and been validated in some centers on the efficacy of differentiating adenomatous and hyperplastic polyps. However, most studies enrolled diminutive polyps less than 5mm and the efficacy of non-magnified NBI in differentiating type-2 and type-3 lesions has not been reported. To promote this simple classification, we design this multicenter study to evaluate the predictive validity and performance characteristics of the non-magnified NBI in diagnosing polyps during both image and real-time process.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal lesions | Other | Device: NBIAll lesions will be observed with NBI and removed endoscopically or surgically for histological diagnosis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with colorectal lesions during colonoscopy examination
- Informed consent available
Key exclusion criteria (4 listed)
- Suspect of advanced colorectal cancer
- History of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
- Poor bowel preparation
- Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc
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 |
|---|---|---|
| NBIAlso: Evis Lucera system (CV-260, Olympus Inc, Japan), high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan), magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)All detected colorectal lesions will be examined by high-definition NBI. For type 2 and type 3 lesions, subsequent magnifying NBI examination will be performed. | Device | colorectal lesions |
Primary outcome
Accuracy of NICE classification in histological prediction by gastroenterological fellows
Time frame: within two weeks after polypectomy
Diagnostic accuracy of gastroenterological fellows using non-magnified NBI according to NICE classification in histological prediction of polyps, compared with histologic examination
1 secondary outcome
Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions.
Time frame: two weeks after endoscopical or surgical resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Derived from this study: PubMed 31895484Zhang QW, Zhang JJ, Yang AM, Sheng JQ, Liu YL, Li ZS, Chen HY, Feng N, Jiang QW, Jin P, Zhang LM, Fu HY, Gao YJ, Ge ZZ, Li XB. Feasibility of using narrow band imaging international colorectal endoscopic classification for diagnosing colorectal neoplasia in China: A multicenter pilot observational study. J Dig Dis. 2020 Feb;21(2):88-97. doi: 10.1111/1751-2980.12841.
- Individual participant dataSharing planned: Undecided
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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.
Zhizheng Ge, MD,Ph.D principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai ,China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NBI in people with Colorectal Polyps, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 2 inclusion and 4 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 10 May 2016. 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 China. 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 Zhizheng Ge, MD,Ph.D (86-21-58752345, zhizhengge@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of NICE classification in histological prediction by gastroenterological fellows (time frame: within two weeks after polypectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02033980, which also lists 1 linked publication.
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 10 May 2016.