Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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A prospective randomized two-part clinical trial comprising patients with recurrent pTa low grade bladder tumors. Study objectives and purpose: 1st Objective: To evaluate whether small pTa bladder tumours can be removed with diode laser in an outpatient department with similar efficacy as by TUR-BT resection in the operating theatre. 2nd Objective: To evaluate the patients experience of symptoms during laser treatment in the outpatient department (OPD) using quality of life (QOL) questionnaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation). 3rd Objective: To evaluate whether patients prefer standard transurethral bladder tumor resection (TUR-BT) in the operating theatre (OT) or laser treatment in the OPD. 4th Objective: To evaluate the safety after laser treatment in the OPD. Efficacy: 1st Endpoint: Proportion of patients with no tumor tissue in the bladder after 4 months and 12 months. 2nd Endpoint: Visual Analog Scale Score (pain evaluation) in patients having tumor removed by laser in the OPD. General urinary problems and QOL one week after the laser treatment. The Danish validated questionnaire (QLQ- BLS24) from EORTC will be used. 3rd Endpoint: Patients preference for either OPD laser treatment procedure or TUR-BT in the OT as inpatient procedure. 4th Endpoint: Character and severity of adverse events in relation to the outpatient treatment. Study Inclusion criteria: Ta low grade bladder tumor recurrences Up to a tumor size of 1,5 cm Up to 6 tumors Eligible patients for TUR-BT Exclusion criteria: Patients with porphyria Known hypersensitivity to Hexvix® or porfhyrins Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa Dementia Macroscopic hematuria Pregnant or breast feeding women Expected poor compliance estimated by the investigators Patients < 18 years Patients who do not read or understand Danish

Official Title
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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?

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: Bladder tumor resection using diathermia
* Device: Diode laser (980 nm) tumor destruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ta low grade bladder tumor recurrences Up to a tumor size of 1,5 cm Up to 6 tumors Eligible patients for TUR-BT in GA Exclusion Criteria: Patients with porphyria Known hypersensitivity to Hexvix® or porfhyrins Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa Dementia Macroscopic hematuria Pregnant or breast feeding women Expected poor compliance estimated by the investigators Patients < 18 years Patients who do not read or understand Danish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inpatient TUR-BT<br>Transurethral bladder tumor resection in operating theatre as inpatient. | Device: Bladder tumor resection using diathermia<br>* Conventional bladder tumor resection using diathermia<br>|
| Experimental: laser bladder tumor destruction<br>Outpatient laser mediated destruction of bladder tumors (LMD-BT) | Device: Diode laser (980 nm) tumor destruction<br>* Laser mediated destruction of bladder tumors (LMD-BT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser, Bladder cancer, Treatment, Outpatient, TUR-BT