Prospective Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging

A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01004211

Enrollment

188

Registered

2009-10-29

Start date

2009-08-31

Completion date

2011-10-31

Last updated

2018-01-17

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

Conditions

Non Muscle Invasive Bladder Cancer

Keywords

bladder cancer, recurrence

Brief summary

To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective within patient trials but only as an add on procedure. This results in a bias that does not allow to determine the real impact of such innovative technologies on bladder cancer management. Hereby we propose the first prospective randomized trial which compares narrow band imaging trans urethral resection as a stand alone procedure versus white light transurethral resection. The primary end point is to assess the recurrence rate of bladder cancer lesions with each treatment modality. The study is designed to disclose an inferior recurrence rate (estimated 10%) in the group treated by narrow band imaging transurethral resection respect to the control group, treated by standard transurethral resection.

Interventions

PROCEDURENarrow band imaging transurethral resection

Transurethral resection of bladder lesion by mean of narrow band imaging

PROCEDUREStandard transurethral resection

Transurethral resection of bladder lesion by mean of standard white light

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* All patients must be older than 18 years of age and female patients who are pregnant, breast feeding or not on adequate contraceptive measures will be excluded. * All patients will provide a written informed consent prior to the study. * Consecutive patients from 2 centers in Liguria (National Institute for Cancer Research - Genova and Centro Urologico di Eccellenza ASL 1 - Imperia) with overt or suspected non muscle invasive bladder cancer, including Cis detected by mean of random biopsies or a positive urinary cytology, will be included in the study and randomized to 2 treatments A, B arms.

Exclusion criteria

* Patients with muscle invasive bladder cancer will be excluded. * Patients submitted to immediate radical cystectomy after transurethral resection, irrespective of the clinical stage, will be excluded.

Design outcomes

Primary

Measure	Time frame
Recurrence free survival rate	One year

Secondary

Measure	Time frame
Detection rate	At the end of enrollment

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026