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N/A N=965 Randomized Treatment

Comparison Study of Narrow Band Imaging Versus White Light Resection in Patients With Bladder Tumors/Cancer

Bladder Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01180478 ↗
Enrolled (actual)
965
Serious AEs
5.4%
Results posted
Apr 2018
Primary outcome: Primary: Number of Participants With Recurrence and Recurrence Rate at 1 Year Following Narrow Band Imaging and TURB (Arm A) Versus White Light Trans Urethral Resection of Bladder Cancer (TURB) (Arm B) in Patients With Non Muscle Invasive (pTa/T1) Bladder Cancer. — 104; 109 Participants — p=0.585

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
White Light (Device); Narrow Band Imaging (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Clinical Research Office of the Endourological Society
Primary completion
Nov 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Recurrence and Recurrence Rate at 1 Year Following Narrow Band Imaging and TURB (Arm A) Versus White Light Trans Urethral Resection of Bladder Cancer (TURB) (Arm B) in Patients With Non Muscle Invasive (pTa/T1) Bladder Cancer.		 104; 109 0.585
SECONDARY
Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection		 59; 61 0.742
SECONDARY
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.		 415; 429; 28; 19; 23; 21 0.170
SECONDARY
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.		 36; 27; 9; 7; 8; 10 0.311
SECONDARY
Recurrence Rate Related to Additional Treatment Following TURB.		 27; 27 0.553

Summary

The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for treatment of primary or recurrent non-muscle invasive bladder cancer
  • Patients greater than 18 years of age
  • No tumors in the upper tract (kidneys or ureters)
  • No previous pelvic radiation

Exclusion Criteria

  • Gross hematuria at the time of resection making visualization with NBI not possible
  • Participation in other clinical studies with investigations drugs concurrently or within 30 days.
  • Pregnancy
  • Conditions associated with a risk of poor compliance or unwilling to follow up
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01180478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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