Bladder Tumors Clinical Trial
Official title:
Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department
- Primary Objective: To show that small pTa bladder tumors can be removed with diode
laser in an outpatient department.
- Secondary Objective: To evaluate the patients' symptoms during and after the laser
TURBT.
- Tertiary Objective: To evaluate the rate of remnant tumor tissue one month after the
laser TURBT.
The patients will have a PDD guided flexible cystoscopy performed and the bladder tumor will
be removed by a diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms).The
treatment will take place in the OPD in awaken patients. One hour prior to the treatment the
patient will have Hexvix® (photodynamic substance) and Lidocaine 20 ml (pain treatment)
installed in the bladder. Simultaneous pain treatment will be oral Paracetamol 1 g and
Ibuprofen 600 mg. Biopsy from the tumor will be taken to confirm the histological diagnosis.
Immediately after the procedure the pain assessed by the VAS score will be recorded and the
patients are given a QOL questionnaire (EORTC QLQ-BLS24) and a stamped envelope and are
asked to return it one week later. The patients will be telephoned after 5 days to remind on
the questionnaire and to ash, whether they has had a urinary infection after the procedure.
One month after the laser TURBT a flexible PPD and SPIES guided cystoscopy is performed in
the OPD to evaluate the laser efficacy. To confirm that all tumour tissue has been removed a
biopsy will be taken from the previous tumor place. The biopsy will be send to the
pathologist according to the normal procedure for biopsies. Visual presentation of the laser
treated area will be visualized using PDD and SPIES.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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