Bladder CancerNCT01180478
Comparison Study of Narrow Band Imaging Versus White Light Resection in Patients With Bladder Tumors/Cancer
A study testing White Light and Narrow Band Imaging in people with Bladder Cancer, run by Clinical Research Office of the Endourological Society.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- White Light and Narrow Band Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 965 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Multi-center, International Study to Compare Use of Narrow Band Imaging (NBI) Versus White Light(WL) During Transurethral Resection of Bladder Tumors (TURB) to Asses Recurrence of Bladder Cancer in Terms of Safety and Efficacy
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.
Read the detailed description
Currently bladder tumors are diagnosed visually with standard cystoscopy that uses white light, or light that is generated encompassing the entire visual spectrum. Some tumors such as carcinoma in situ may not be visible using white light and require patients to undergo random bladder biopsies in order to find the cancer. Recently the development of photodynamic agents have been shown to enhance these procedures to accomplish better resection and identify over-looked tumors. However, these methods often require the instillation of dyes into the bladder as well as specialized cystoscopes. Narrow band imaging (NBI) is now available which uses a special filter to limit the light to only certain wavelengths which allows the identification of areas of increased vascularity or abnormalities without the need for dyes. NBI has been investigated in gastro-intestinal disease and found to be beneficial. Early reports in urology suggest that this technology may reduce the number of tumors that are missed which could impact the recurrence rate of bladder tumors, but this is not known at this time.
- Conditions
- Bladder Cancer
- Being tested
- White Light, Narrow Band Imaging
- Keywords
- Bladder Cancer, Urothelial carcinoma, Stage pTa or pT1, NMIBC Ta/T1, Narrow Band Imaging, White Light Cystoscopy, Transurethral resection, Superficial bladder tumor, Positive urine cytology
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White LightDevice
White Light Cystoscopy
Narrow Band ImagingDevice
Narrow Band Imaging
| Study group | Role | What they receive |
|---|---|---|
| Narrow Band Imaging | Other | Narrow Band Imaging (NBI) Receives: Device: Narrow Band Imaging |
| White Light Trans Urethral Resection | Other | White Light Trans Urethral Resection Receives: Device: White Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The primary outcome measure was recurrence rate at 1 year. A recurrence was defined as the new occurrence of a bladder cancer at the same site as or at a different site from the index cancer.
Measured: 1 year after treatment
Secondary outcomes (4)
Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection
Measured: 3 months after treatment
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.
Grade II Requiring pharmacological treatment with drugs other than those allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
Grade III Requiring surgical, endoscopic or radiological intervention Grade III-a Intervention not under general anaesthesia Grade III-b Intervention under general anaesthesia
Grade IV Life-threatening complication (including CNS complications: brain haemorrhage, ischaemic stroke, subarachnoid bleeding, but excluding transient ischaemic attacks) requiring IC/ICU management Grade IV-a Single organ dysfunction (including dialysis) Grade IV-b Multi-organ dysfunction
Grade V Death of a patient
Measured: 30 days
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
We looked at different perioperative complications in order to discover peri-operative morbidity after instrumental treatment. The following variables were analyzed: Bleeding, Fever, UTI, Bladder cramps, DVT, CVA/TIA, Lung embolism, Sepsis, Acute Abdomen, and Other perioperative complications.
Measured: peri-operative
Recurrence Rate Related to Additional Treatment Following TURB.
Measured: Until 135 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 965 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Office of the Endourological Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean de la Rosette, MD, Study director, AMC University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180478
- Sponsor's protocol ID
- 10-004660
- Status last verified
- Mar 2018
- First submitted
- 10 Aug 2010
- Last updated
- 25 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, International Study to Compare Use of Narrow Band Imaging (NBI) Versus White Light(WL) During Transurethral Resection of Bladder Tumors (TURB) to Asses Recurrence of Bladder Cancer in Terms of Safety and Efficacy
- ClinicalTrials.gov ID
- NCT01180478
- Acronym / sponsor ID
- 10-004660
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Urothelial carcinoma, Stage pTa or pT1, NMIBC Ta/T1, Narrow Band Imaging, White Light Cystoscopy, Transurethral resection, Superficial bladder tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 965 participants (actual)
- Lead sponsor
- Clinical Research Office of the Endourological SocietyUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Posted 25 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently bladder tumors are diagnosed visually with standard cystoscopy that uses white light, or light that is generated encompassing the entire visual spectrum. Some tumors such as carcinoma in situ may not be visible using white light and require patients to undergo random bladder biopsies in order to find the cancer. Recently the development of photodynamic agents have been shown to enhance these procedures to accomplish better resection and identify over-looked tumors. However, these methods often require the instillation of dyes into the bladder as well as specialized cystoscopes. Narrow band imaging (NBI) is now available which uses a special filter to limit the light to only certain wavelengths which allows the identification of areas of increased vascularity or abnormalities without the need for dyes. NBI has been investigated in gastro-intestinal disease and found to be beneficial. Early reports in urology suggest that this technology may reduce the number of tumors that are missed which could impact the recurrence rate of bladder tumors, but this is not known at this time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow Band Imaging | Other | Device: Narrow Band ImagingNarrow Band Imaging (NBI) |
| White Light Trans Urethral Resection | Other | Device: White LightWhite Light Trans Urethral Resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White LightWhite Light Cystoscopy | Device | White Light Trans Urethral Resection |
| Narrow Band ImagingNarrow Band Imaging | Device | Narrow Band Imaging |
Primary outcome
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.
Time frame: 1 year after treatment
The primary outcome measure was recurrence rate at 1 year. A recurrence was defined as the new occurrence of a bladder cancer at the same site as or at a different site from the index cancer.
4 secondary outcomes
Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection
Time frame: 3 months after treatment
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
Time frame: 30 days
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
Time frame: peri-operative
Recurrence Rate Related to Additional Treatment Following TURB.
Time frame: Until 135 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean de la Rosette, MD study director
AMC University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing White Light and Narrow Band Imaging in people with Bladder Cancer, run by Clinical Research Office of the Endourological Society.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.