Bladder Cancer Clinical Trial
— LaserIIIOfficial title:
Is Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors (LMD-BT) as Good as Conventional Inpatient PDD Guided Transurethral Tumor Resection in Patients With Low Grade Non-invasive (Ta) Bladder Tumors?
This study compare the efficacy of conventional photodynamic (PDD) guided transurethral bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction of bladder tumors through flexible cystoscopes.
Status | Recruiting |
Enrollment | 248 |
Est. completion date | February 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Ta low grade bladder tumor recurrences 2. Up to a tumor size of 1,5 cm 3. Up to 6 tumors 4. Eligible patients for TUR-BT in GA Exclusion Criteria: 1. Patients with porphyria 2. Known hypersensitivity to Hexvix® or porfhyrins 3. Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa 4. Dementia 5. Macroscopic hematuria 6. Pregnant or breast feeding women 7. Expected poor compliance estimated by the investigators 8. Patients < 18 years 9. Patients who do not read or understand Danish |
Country | Name | City | State |
---|---|---|---|
Denmark | Urological department, Frederiksberg Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Bispebjerg and Frederiksberg |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor recurrence histological identified in biopsy obtained during cystoscopy | Numbers (%) of patients vith histological proven recurrence of bladder tumor after 4 months | 4 months | |
Secondary | Lower urinary symptoms caused by laser treatment. | Using the EORTC questionnaire QLQ-BLS24 the extent of symptoms are given on a unique score from 0-100, with 0 being no symptoms and 100 are worst symptoms. Mean and range score in the two arms will be compared statistically. | 2 weeks | |
Secondary | Side effects to laser treatment. | Symptoms measured by one unique score according to the Clavien-Dindo grading system. Mean and range score in the two arms will be compared statistically. | 2 weeks | |
Secondary | Pain during laser treatment | The patients record pain on a visual analogue scale of 0-10. Zero corresponds to no pain. Ten correspond to the worst possible pain. | Evaluated immediately after laser treatment |
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