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Comparison of White Light, PDD and NBI in Detection of Flat Dysplasia and CIS at TURB - a Study of Trimodality (DaBlaCa-8)

A

Aarhus University Hospital

Status

Completed

Conditions

Narrow Band Imaging and PDD in Cystoscopy

Treatments

Device: NBI and PDD

Study type

Observational

Funder types

Other

Identifiers

NCT02313662
DaBlaCa-8

Details and patient eligibility

About

All patients planned for PDD guided TURB can be included in this study. Two different optics with PDD and NBI are applied to the resectoscope in addition to regular WL.

First, a WL cystoscopy is made and any suspect areas are noted on the registration form, then NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD with registration of any additional findings. To adjust for bias introduced by photo bleaching, the second part of the study will be performed with PDD as the second modality. Any flat lesions will be biopsied if they appear suspicious in one of the modalities.

The registration form is completed by the surgeon, once the pathology results are known.

A total number of 152 patients is planned to be included.

Enrollment

153 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing PDD according to the Danish guidelines

Exclusion criteria

  • Patients not fulfilling the inclusion criteria

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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