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The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions

The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01431703
Enrollment
326
Registered
2011-09-09
Start date
2010-05-31
Completion date
2011-04-30
Last updated
2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Lesion

Keywords

narrow band imaging, learning curve, colorectal, differential diagnosis, with colorectal lesion, NBI with magnification

Brief summary

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.

Interventions

None listed

Sponsors

Zhizheng Ge
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Ages 16 to 85 * Any patient undergoing NBI with magnification colonoscopy exam and found with colorectal lesions

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic LesionsFor this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.

Participant flow

Participants by arm

ArmCount
NBI With Magnification
Patients with lesions diagnosed by Sano classification using NBI with magnification
326
Total326

Baseline characteristics

CharacteristicNBI With Magnification
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
97 Participants
Age, Categorical
Between 18 and 65 years
229 Participants
Age, Continuous57.4 years
STANDARD_DEVIATION 10.9
Gender
Female
131 Participants
Gender
Male
195 Participants
Region of Enrollment
China
326 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 326
serious
Total, serious adverse events
0 / 326

Outcome results

Primary

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.

ArmMeasureGroupValue (NUMBER)
NBI With MagnificationAccuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic LesionsAccuracy94.3 percentage of lesions
NBI With MagnificationAccuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic LesionsSensitivity98.0 percentage of lesions
NBI With MagnificationAccuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic LesionsSpecificity92.0 percentage of lesions

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026