Randomized controlled trial on prototype magnifying endoscopy (ME) with narrow-band imaging (NBI) for diagnosis of superficial head and neck (H&N) and esophageal cancer
Not Applicable
- Conditions
- H&N and Esophageal cancer
- Registration Number
- JPRN-UMIN000007585
- Lead Sponsor
- The Jikei University School of Medicine
- Brief Summary
inety-three patients participated; a total of 28 SCs were detected in the pharynx and esophagus. The detection rates of DF-NBI and CM-NBI for SC were 82% and 71%, respectively. The lower limit of the 90% confidence interval for differences between the detection rates exceeded the noninferiority threshold. Although not significantly different, the other diagnostic values tended to be higher for DF-NBI than CM-NBI. The results of questionnaires answered by endoscopists showed DF-NBI received a significantly higher or nearly significantly higher evaluation than CM-NBI, excepting a single question.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 74
Inclusion Criteria
Not provided
Exclusion Criteria
esophageal stenosis esophageal varices
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of detection rate of superficial H&N and esophageal cancer between prototype ME and current ME in conjunction with NBI
- Secondary Outcome Measures
Name Time Method Comparison of accuracy of superficial H&N and esophageal cancer between prototype ME and current ME in conjunction with NBI