Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors

Not Applicable

• Conditions: Bladder Cancer
• Interventions: Device: Bladder tumor resection using diathermia; Device: Diode laser (980 nm) tumor destruction

• Registration Number: NCT02886026
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

Brief Summary

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

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

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-09-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inpatient TUR-BT	Bladder tumor resection using diathermia	Transurethral bladder tumor resection in operating theatre as inpatient.
laser bladder tumor destruction	Diode laser (980 nm) tumor destruction	Outpatient laser mediated destruction of bladder tumors (LMD-BT)

Primary Outcome Measures

Name	Time	Method
Tumor recurrence histological identified in biopsy obtained during cystoscopy	4 months	Numbers (%) of patients vith histological proven recurrence of bladder tumor after 4 months

Secondary Outcome Measures

Name	Time	Method
Pain during laser treatment	Evaluated immediately after 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.
Side effects to laser treatment.	2 weeks	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.
Lower urinary symptoms caused by laser treatment.	2 weeks	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.

Trial Locations

Locations (1)

Urological department, Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark