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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

NCT01073241

Benign Prostatic Hyperplasia

UNKNOWN NA

Open Versus Laparoscopic Radical Cystectomy

NCT02345499

Bladder Cancer

UNKNOWN PHASE2

Robotic Radical Cystectomy Outcomes

NCT04900558

Bladder Cancer Muscle-Invasive Bladder Carcinoma Oncology +2 more

RECRUITING

Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.

NCT03434132

Bladder Cancer

COMPLETED NA

Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma

NCT03544437

Upper Tract Urothelial Carcinoma

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Muscle Invasive Bladder Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard transurethral resection

Patients will be submitted to standard white light transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer

Group Type ACTIVE_COMPARATOR

Standard transurethral resection

Intervention Type PROCEDURE

Transurethral resection of bladder lesion by mean of standard white light

Narrow band imaging transurethral resection

The system will be switched to narrow band imaging by simply pushing a button. Transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer will be performed; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer.

Group Type EXPERIMENTAL

Narrow band imaging transurethral resection

Intervention Type PROCEDURE

Transurethral resection of bladder lesion by mean of narrow band imaging

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Narrow band imaging transurethral resection

Transurethral resection of bladder lesion by mean of narrow band imaging

Intervention Type PROCEDURE

Standard transurethral resection

Transurethral resection of bladder lesion by mean of standard white light

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No