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

Completed

• Conditions: Narrow Band Imaging and PDD in Cystoscopy

• Registration Number: NCT02313662
• Lead Sponsor: Aarhus University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Patients undergoing PDD according to the Danish guidelines

Exclusion Criteria

• Patients not fulfilling the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of CIS	Baseline

Trial Locations

Locations (4)

Hospitalsenheden Vest; 🇩🇰 Holstebro, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Oslo University Hospital; 🇳🇴 Oslo, Norway