Validation of optical enhancement for the prediction of colorectal polyp histology

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005072

Enrollment

120

Registered

2020-06-01

Start date

2020-01-28

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

None listed

Interventions

Medical Device : This is a prospective study of patients undergoing colonoscopy or polypectomy. Present and explain the study to the subject and sign it with the voluntary intention. When the enoscopi

s polyps, he or she operates the pentax EPK-i7010 endoscope button to take polyps with optical enhancement (OE), classify them as 1,2,3 according to the NICE classification, and classify the polyps ac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who undergoing colonoscopy and found colonic polyps - Patients who undergoing colon polypectomy

Exclusion criteria

Exclusion criteria: - Patients who disagree with or withdraw their conset

Design outcomes

Primary

Measure	Time frame
Evaluate the specifity of NICE classification, JNET classification, and pathological results.;Evaluate the positive predictiveness of whether the NICE classification, JNET classification and pathological results are consistent.;Evaluate the negative predictiveness of whether the NICE classification, JNET classification and pathological results are consistent.;Evaluate the sensitivity of NICE classification, JNET classification, and pathological results.	—

Measure

Time frame

Evaluate the specifity of NICE classification, JNET classification, and pathological results.;Evaluate the positive predictiveness of whether the NICE classification, JNET classification and pathological results are consistent.;Evaluate the negative predictiveness of whether the NICE classification, JNET classification and pathological results are consistent.;Evaluate the sensitivity of NICE classification, JNET classification, and pathological results.

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Secondary

Measure	Time frame
Endoscopic doctors who participate in the pathology prediction have more than 2000 experiences with colonoscopy, two experienced groups with full knowledge of NICE classification and JNET classification, and less than 1,000 cases with colonoscopy. Divided into eight trainee groups for the study, assessing sensitivity, specificity, positive predictive value, and negative predictive value, respectively.	—

Measure

Time frame

Endoscopic doctors who participate in the pathology prediction have more than 2000 experiences with colonoscopy, two experienced groups with full knowledge of NICE classification and JNET classification, and less than 1,000 cases with colonoscopy. Divided into eight trainee groups for the study, assessing sensitivity, specificity, positive predictive value, and negative predictive value, respectively.

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Countries

Korea, Republic of

Contacts

Public ContactJong Yoon Lee

Dong-A University Hospital

Outcome results