Colorectal LesionNCT01431703
The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions
An observational study of Colorectal Lesion, run by Zhizheng Ge.
Trial summary
It exists a learning curve in using NBI with magnification to differentiating colorectal lesions. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Colorectal Lesion
- How many people
- 326 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Apr 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: academic hospital endoscopist of digestive department
Who may be able to join
- Ages 16 to 85
- Any patient undergoing NBI with magnification colonoscopy exam and found with colorectal lesions
Who cannot join
- Unwilling to consent
- Had surgery of colorectal tumors
- Using NSAIDS
- Diagnosed or suspected IBD
- Familial adenomatous polyposis(FAP) or hereditary non-polyposis colorectal(HNPCC) or other hereditary disease
About this study
It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.
Read the detailed description
It is very useful to use narrow-band imaging and Sano CP analysis in the differential diagnosis of colorectal lesions. The endoscopists who had never used NBI or no knowledge of NBI can have effective and stable diagnostic accuracy after using NBI with magnification to diagnose 15 target and non-target lesions respectively.
- Conditions
- Colorectal Lesion
- Keywords
- narrow band imaging, learning curve, colorectal, differential diagnosis, with colorectal lesion, NBI with magnification
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions
Measured: For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal LesionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhizheng Ge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431703
- Sponsor's protocol ID
- rjyyxhk0923
- Status last verified
- Jan 2017
- First submitted
- 8 Sep 2011
- Last updated
- 1 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions
- ClinicalTrials.gov ID
- NCT01431703
- Acronym / sponsor ID
- rjyyxhk0923
- Conditions
- Colorectal Lesion
- Keywords
- narrow band imaging, learning curve, colorectal, differential diagnosis, with colorectal lesion, NBI with magnification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Zhizheng GeUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Posted 1 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.
Detailed description
It is very useful to use narrow-band imaging and Sano CP analysis in the differential diagnosis of colorectal lesions. The endoscopists who had never used NBI or no knowledge of NBI can have effective and stable diagnostic accuracy after using NBI with magnification to diagnose 15 target and non-target lesions respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- academic hospital endoscopist of digestive department
Key inclusion criteria (2 listed)
- Ages 16 to 85
- Any patient undergoing NBI with magnification colonoscopy exam and found with colorectal lesions
Key exclusion criteria (5 listed)
- Unwilling to consent
- Had surgery of colorectal tumors
- Using NSAIDS
- Diagnosed or suspected IBD
- Familial adenomatous polyposis(FAP) or hereditary non-polyposis colorectal(HNPCC) or other hereditary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions
Time frame: For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Lesion, run by Zhizheng Ge.
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 5 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: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions (time frame: For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.). 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 1 Mar 2017.