Clinical trial NCT02659332: Laser Treatment of Bladder Tumors in the Outpatient Department
Official title: Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Tumors
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Recurrence of pTa low grade urothelial bladder tumor
* Tumor \< 1.5 cm
* \< 6 tumors

Exclusion Criteria:

* Patients with porphyria
* Known hypersensitivity to Hexvix® or porfhyrins
* Use of any anticoagulantia
* Macroscopic hematuria
* Pregnant or breast feeding women
* Expected poor compliance
* Patients \< 18 years
* Patients who do not read or understand Danish

Primary outcomes:
measure: Complete Removal by One Laser Treatment (Proportions of patients where the bladder tumors are completely removed by one laser)
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Urology, Bispebjerg and Frederiksberg Hospital
state: Copenhagen
Study officials:
affiliation: Bispebjerg and Frederiksberg Hospital
name: Gregers G Hermann, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
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