The role of Image Enhancement Systems in the management of patients with non-muscle invasive bladder cancer

• Register: ISRCTN
• Last refreshed on: 28 November 2016
• Main ID: ISRCTN90207346
• Date of registration: 03/11/2016
• Prospective Registration: No
• Primary sponsor: University of Crete, Medical School
• Public title: The role of Image Enhancement Systems in the management of patients with non-muscle invasive bladder cancer
• 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
• Date of first enrolment: 20/02/2015
• Target sample size: 211
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN90207346
• Study type: Observational
• Study design: Case series diagnostic accuracy study (Diagnostic)

Countries of recruitment

Greece

Contacts

• Name: Charalampos Mamoulakis

Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Participation in a similar protocol
2. Absence of upper urinary tract tumors
3. Pregnancy/breastfeeding

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Non-muscle-invasive bladder cancer (NMIBC)
Cancer

Intervention(s)

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)).

Primary Outcome(s)

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(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

University of Crete, Medical School