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validation study of an endoscopic diagnosis algorithm for duodenal lesion using magnified endoscopic examination with image-enhanced endoscopy

validation study of an endoscopic diagnosis algorithm for duodenal lesion using magnified endoscopic examination with image-enhanced endoscopy - VED study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000045359
Enrollment
1000
Registered
2021-09-02
Start date
2022-05-18
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

duodenal lesions

Interventions

None listed

Sponsors

Keio University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients undergoing upper gastrointestinal endoscopy at our hospital oncology center, division of research and development for minimally invasive therapy

Exclusion criteria

Exclusion criteria: 1) patients with impossibility for the adaptation according to the guideline for antithrombotic drugs of japanese gastroenterological endoscopy society 2) patients with disorder about the function of blood coaglation 3) patients with severe organ dysfunction 4) patients with a history of upper gastrointestinal surgery 5) familial adenomatous polyposis patients 6) lesions for which biopsy has already been performed 7) lesions diagnosed as submucosal tumor, erosion or ulcer by endoscopist 8) patients who have already entered this study once during the study period 9) patients with another inappropreate reasons judged by the doctor

Design outcomes

Primary

MeasureTime frame
Accuracy for neoplastic lesions of our suggested diagnostic algorithm

Secondary

MeasureTime frame
To validate following items of our suggested diagnostic algorithm. 1) sensitivity / specificity / positive predictive value / negative predictive value for neoplastic lesions 2) sensitivity / specificity / positive predictive value / negative predictive value for non neoplastic lesions 3) differences in diagnostic rates by endoscopic diagnostic proficiency 4) differences in diagnostic rates by endoscope equipment

Countries

Japan

Contacts

Public ContactYoko Kubosawa

Keio University, school of medicine Gastroenterology

yoooko102@keio.jp0333531211

Outcome results

None listed

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