Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors (LaserIII)

University Hospital Bispebjerg and Frederiksberg

Status: Unknown

Conditions: Bladder Cancer

Treatments: Device: Diode laser (980 nm) tumor destruction; Device: Bladder tumor resection using diathermia

Study type: Interventional

Funder types: Other

Identifiers

NCT02886026

URU06

Details and patient eligibility

About

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.

Full description

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:

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

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

Inpatient TUR-BT

Active Comparator group

Description:

Transurethral bladder tumor resection in operating theatre as inpatient.

Treatment:

Device: Bladder tumor resection using diathermia

laser bladder tumor destruction

Experimental group

Description:

Outpatient laser mediated destruction of bladder tumors (LMD-BT)

Treatment:

Device: Diode laser (980 nm) tumor destruction