Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors
NCT ID: NCT02886026
Last Updated: 2017-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
248 participants
INTERVENTIONAL
2016-06-30
2019-02-28
Brief Summary
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Detailed Description
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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:
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
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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inpatient TUR-BT
Transurethral bladder tumor resection in operating theatre as inpatient.
Bladder tumor resection using diathermia
Conventional bladder tumor resection using diathermia
laser bladder tumor destruction
Outpatient laser mediated destruction of bladder tumors (LMD-BT)
Diode laser (980 nm) tumor destruction
Laser mediated destruction of bladder tumors (LMD-BT)
Interventions
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Bladder tumor resection using diathermia
Conventional bladder tumor resection using diathermia
Diode laser (980 nm) tumor destruction
Laser mediated destruction of bladder tumors (LMD-BT)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University Hospital Bispebjerg and Frederiksberg
OTHER
Responsible Party
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Gregers Gautier Hermann
Consultant Urologist
Principal Investigators
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Gregers G Hermann, DM Sc
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, Frederiksberg hospital
Locations
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Urological department, Frederiksberg Hospital
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Gregers G Hermann, MD
Role: primary
Other Identifiers
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URU06
Identifier Type: -
Identifier Source: org_study_id