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Evaluation of the efficacy of narrow band imaging with magnifying colonoscopy for the diagnosis of dysplasia.

Evaluation of the efficacy of narrow band imaging with magnifying colonoscopy for the diagnosis of dysplasia. - Prospective analysis of NBI-ME for colorectal dysplasia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003740
Enrollment
550
Registered
2010-07-01
Start date
2010-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Colorectal neoplasm

Interventions

Magnifying observation using magnifying endoscope.

Sponsors

Osaka Medical Center for Cancer and Cardiovascular Diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are undergoing colonoscopy for positive fecal occult blood test, surveillance colonoscopy after endoscopic resection, and colonoscopic resection of colorectal neoplasms.

Exclusion criteria

Exclusion criteria: 1)Patients who had previously undergone histological examination. 2)Patients with open bleeding or symptoms suspected colonic stenosis. 3)Patients with inflammatory bowel disease, familial polyposis and known colon neoplasm. 4)Patients who are receiving anticoaglant medication or having bleeding tendency. 5)Patients with severe organ failure. 6)Patients without informed consent. 7)Patients who are regarded in-eligible by the doctor who participates in this study.

Design outcomes

Primary

MeasureTime frame
Specificity of NBI-ME in accurate decision for low grade dysplasia.

Secondary

MeasureTime frame
Procedure time (insertion and observation), Diagnostic ability (sensitivity, specificity and accuracy) for high grade dysplasia, low grade dysplasia and non-neoplastic lesion using NBI-nonME and NBI-ME, Accurate clinical decision rate (resect and discard, resect and send and leave it in situ) using NBI-nonME and NBI-ME. Diagnostic accuracy according to the lesion size (<5mm, >6mm). Adverse events.

Countries

Japan

Contacts

Public ContactYoji Takeuchi

Osaka Medical Center for Cancer and Cardiovascular Diseases Gastrointestinal Oncology

takeuti-yo@mc.pref.osaka.jp06-6972-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026