OPTIMA

Study titel: Outpatient laser ablation of large recurrent non-muscle invasive bladder cancer – a proscpective feasibility study.

Aim: The aim of the present study is to investigate the feasibility and tolerability of the Olympus Soltive laser in treatment of large recurrent low-grade Ta tumours in an outpatient setting

Methods: The study will be conducted as a prospective feasibility study. Patients will be included from Aarhus University Hospital (Denmark), Fundació Puigvert (Spain), Motol University Hospital (Czech Republic) and Institut Universitaire du Cancer Toulouse Oncopole (France). One hour prior to commencement of the laser ablation procedure a local anaesthetic will be applied, consisting of 60ml of a 20g/L lidocaine-solution administered through a urethral catheter. A cystoscopy will be performed using both white-light and narrow-band imaging when appropriate. The tumour number, size of the largest tumour and the localisation of the tumours will be registered. After taking a representative biopsy, all remaining tumours will be vaporised, and haemostasis secured. The biopsy will be handled by the pathology unit according to standard guidelines. Vaporisation is performed using brushing movements while the distal tip of the laser fibre is held 2–3 mm above the tissue.

On the same day, after completion of the laser ablation procedure, patients will answer a survey consisting of a visual analogue scale (VAS) estimating the level of discomfort, their treatment preferences (laser/TURBT) in case of subsequent recurrences, and their opinion towards recommending laser treatment for other patients.

The treating urologist will record incidents or immediate complications after the procedure.

On day one and fourteen following the procedure, a research nurse will contact patients in order to assess satisfaction with the choice of procedure and to register any adverse events. These data will be recorded in the eCRF in the online REDCap web application database. All patients will continue with the standard follow-up regime for non-muscle invasive bladder cancer in accordance with European/local guidelines.

Inclusion/exclusion criteria: 
Inclusion criteria

  • At least one tumour with a diameter > 1 cm
  • Papillary/non-solid tumours
  • Previous low-grade NMIBC
  • Age ≥ 18 years
  • Ability to understand the participant information orally and in writing, in Danish, Spanish, Czech or French respectively
  • Signed consent form


Exclusion criteria

  • Tumour diameter > 3cm
  • Tumour in the prostatic urethra
  • Previous CIS, high-grade disease or muscle invasive bladder cancer with no later low-grade recurrence
  • Positive cytology within 3 months (testing not mandatory in patients with low-grade tumours)
  • Pregnancy

 

location (map)
Status

Kontakt

Ph.d. studerende:
Vanaja Kumarasegaram
vanakuma@rm.dk