Plain English Summary
Background and study aims
Bladder cancer is one of the most common types of cancer worldwide. The most common type of bladder cancer is non-muscle invasive bladder cancer (NMIBC) and accounts for around 75% of all newly diagnosed cases. This is where the tumor is confined to the inner surface of the bladder, without spreading deeply in the bladder wall or to other parts of the body. Patients with NMIBC are submitted to tumor removal through their urethra (the tube through which urine passes) and the procedure is called transurethral resection of NMIBC (TUR-NMIBC), in which an instrument called resectoscope (a lighted tube with a lens and a loop-shaped wire on its tip) is passed up through the urethra and the loop-shaped wire cuts the tumor into small chips with the use of electric current. Depending on the pathology results of the resected (removed) tumor, some patients may have to regularly receive additional treatment (medications placed in the bladder) and also they are usually followed up regularly in order to make sure the cancer has not returned. This is done using a procedure called white-light imaging (WLI) cystoscopy, in which a cystoscope (a thin, lighted tube with a lens) is passed up through the urethra. The bladder is then filled with water or saltwater solution in order to stretch the bladder walls to identify suspicious lesions (damaged areas). In recent years, new techniques have been developed in order to try and improve the accuracy of the detection and identification of these lesions. The Storz Professional Image Enhancement System (SPIES) is a new product which is designed to give a clearer image in a cystoscopy than the traditional white-light cystoscope. The aim of this study is to find out whether SPIES cystoscopy is able to detect suspicious bladder lesions more effectively than WLI cystoscopy.
Who can participate?
Adult patients who have had a NMIBC previously removed.
What does the study involve?
At the beginning of each visit for cystoscopy, each patient undergoes both WLI cystoscopy and SPIES cystoscopy conducted by two urologists. Each urologist performs one type of cystoscopy (either WLI or SPIES) in each patient. Each examiner does not know the results of his colleague. Each patient continues to be assessed with cystoscopies performed in the same way after 3, 6, 9, 12, 18, and 24 months. If a patient is diagnosed with a new tumor at any time during the follow up period, he/she undergoes TUR-NMIBC and further follow up in terms of this study is stopped.
What are the possible benefits and risks of participating?
Patients may benefit from a more accurate diagnosis of their suspicious bladder lesions which could lead to better treatment. There are no risks involved for patients taking part in this study.
Where is the study run from?
University of Crete, Medical School (Greece)
When is the study starting and how long is it expected to run for?
December 2015 to December 2019
Who is funding the study?
University General Hospital of Heraklion (Greece)
Who is the main contact?
Professor Charalampos Mamoulakis
mamoulak@uoc.gr
Study website
Contact information
Type
Public
Contact name
Prof Charalampos Mamoulakis
ORCID ID
http://orcid.org/0000-0002-8662-1275
Contact details
P. O. Box 1031
Heraklion
Crete
71001
Greece
+30 2810 392340
mamoulak@uoc.gr
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
White light imaging vs. Storz Professional Image Enhancement System (SPIES) cystoscopy during follow up of patients submitted to White light – transurethral resection of non-muscle-invasive bladder cancer: A randomized diagnostic trial
Acronym
SPIES
Study hypothesis
The aim of this study is to evaluate whether the follow up of patients submitted to White light – transurethral resection of non-muscle-invasive bladder cancer (TUR-NMIBC) is more accurate when performed using the Storz Professional Image Enhancement System (SPIES) cystoscopy compared to conventional white light (WLI) cystoscopy.
Ethics approval(s)
University General Hospital of Heraklion, Crete, Greece, 19/02/2015, ref: 17968/19-02-2015
Study design
Case series diagnostic accuracy study
Primary study design
Observational
Secondary study design
Study setting(s)
Hospital
Study type
Diagnostic
Patient information sheet
No participant information sheet available
Condition
Non-muscle-invasive bladder cancer (NMIBC)
Intervention
All patients with suspected or confirmed NMIBC submitted to (TUR-NMIBC) using WLI (WLI-TUR-NMIBC) fulfilling specific inclusion criteria will be consecutively and prospectively recruited in the study. Medical history including demographic characteristics, intraoperative findings and pathology reports will be recorded. Participants will be submitted to the typical adjuvant treatment (intravesical chemotherapy or bacillus Calmette-Guérin (BCG) immunotherapy), if needed, according to the current guidelines.
Each patient will be followed-up by an intensive cystoscopy visit schedule. The first follow up cystoscopy visit will take place performed at 3 months after the operation (WLI-TUR-NMIBC). Each patient will afterwards followed up by cystoscopy visits at 3, 6, 9, 12, 18 and 24 month postoperatively. At the beginning of each cystoscopy visit, each patient will undergo both WLI cystoscopy (reference standard test) and SPIES cystoscopy (index test) conducted by two experienced urologists at the same session (without any washout period between tests).
Each examiner will perform one type of cystoscopy (either WLI or SPIES) in each patient. For each patient, a web-based randomization protocol will be used to define the type of cystoscopy (WLI or SPIES) each examiner will conduct (in a randomized sequence). Each examiner, will be blinded to his colleague’s results, and will fill in a pre-defined bladder diagram form. Bladder washout samples will be obtained at the end of each cystoscopy for cytological examination. Patients with tumor recurrence/suspicious lesions will either undergo TUR-NMIBC and/or targeted biopsies (further follow up in terms of this study will stop) or will be marked for further reviewing. Same equipment will be used in all cases (cysto-urethro flexible or rigid fiberoscope (Karl Storz, Tuttlingen, Germany), IMAGE 1 Storz Professional IES platform (SPIESTM; Karl Storz, Tuttlingen, Germany)).
Intervention type
Device
Pharmaceutical study type(s)
Phase
Drug/device/biological/vaccine name(s)
Primary outcome measure
Recurrence rate detection of both the reference and index tests, using positive values for tumour recurrence and negative values for no tumour reoccurrence at 3, 9, 12, 18 and 24 months after WLI-TUR-NMIBC.
Secondary outcome measures
To evaluate the contribution of each cystoscopy type (WLI vs SPIES) in the diagnosis of NMIBC in patients with positive urine cytology, via comparison of diagnosis rates between the two tests
Overall study start date
19/02/2015
Overall study end date
19/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with suspected or confirmed NMIBC fulfilling the following inclusion criteria will be prospectively recruited in the study:
1. Prior WLI-TUR-NMIBC of primary or recurrent tumor(s)
2. Age ≥18 years
3. Written informed consent
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
The target sample size has being calculated to be 211 patients
Participant exclusion criteria
1. Participation in a similar protocol
2. Absence of upper urinary tract tumors
3. Pregnancy/breastfeeding
Recruitment start date
20/02/2015
Recruitment end date
20/02/2015
Locations
Countries of recruitment
Greece
Study participating centre
University General Hospital of Heraklion
Department of Urology
University of Crete Medical School
Heraklion, Crete
71500
Greece
Sponsor information
Organisation
University of Crete, Medical School
Sponsor details
Voutes
Heraklion
Crete
71003
Greece
Sponsor type
University/education
Website
ROR
Funders
Funder type
Not defined
Funder name
University of Crete, Medical School
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
19/02/2020
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|