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

NCT01004211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2018-01-17

No results posted yet for this study

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.

Conditions

  • Non Muscle Invasive Bladder Cancer

Interventions

PROCEDURE

Narrow band imaging transurethral resection

Transurethral resection of bladder lesion by mean of narrow band imaging

PROCEDURE

Standard transurethral resection

Transurethral resection of bladder lesion by mean of standard white light

Sponsors & Collaborators

  • Paolo Puppo

    lead OTHER

Principal Investigators

  • Paolo Puppo, MD · National Institute for Cancer Research, Genoa, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01004211 on ClinicalTrials.gov