Laser Treatment of Bladder Tumors in the Outpatient Department

Not Applicable

• Conditions: Bladder Tumors
• Interventions: Device: TURBT

• Registration Number: NCT02659332
• Lead Sponsor: Gregers G Hermann

Brief Summary

* Primary Objective: To show that small pTa bladder tumors can be removed with diode laser in an outpatient department.

* Secondary Objective: To evaluate the patients' symptoms during and after the laser TURBT.

* Tertiary Objective: To evaluate the rate of remnant tumor tissue one month after the laser TURBT.

Detailed Description

The patients will have a PDD guided flexible cystoscopy performed and the bladder tumor will be removed by a diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms).The treatment will take place in the OPD in awaken patients. One hour prior to the treatment the patient will have Hexvix® (photodynamic substance) and Lidocaine 20 ml (pain treatment) installed in the bladder. Simultaneous pain treatment will be oral Paracetamol 1 g and Ibuprofen 600 mg. Biopsy from the tumor will be taken to confirm the histological diagnosis.

Immediately after the procedure the pain assessed by the VAS score will be recorded and the patients are given a QOL questionnaire (EORTC QLQ-BLS24) and a stamped envelope and are asked to return it one week later. The patients will be telephoned after 5 days to remind on the questionnaire and to ash, whether they has had a urinary infection after the procedure.

One month after the laser TURBT a flexible PPD and SPIES guided cystoscopy is performed in the OPD to evaluate the laser efficacy. To confirm that all tumour tissue has been removed a biopsy will be taken from the previous tumor place. The biopsy will be send to the pathologist according to the normal procedure for biopsies. Visual presentation of the laser treated area will be visualized using PDD and SPIES.

Study Timeline

• Study Start: 2015-02
• Status Verified: 2016-01
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-20
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21
• Primary Completion: 2016-03
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Recurrence of pTa low grade urothelial bladder tumor
• Tumor < 1.5 cm
• < 6 tumors

Exclusion Criteria

• Patients with porphyria
• Known hypersensitivity to Hexvix® or porfhyrins
• Use of any anticoagulantia
• Macroscopic hematuria
• Pregnant or breast feeding women
• Expected poor compliance
• Patients < 18 years
• Patients who do not read or understand Danish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TURBT	TURBT	Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms)

Primary Outcome Measures

Name	Time	Method
Complete Removal by One Laser Treatment (Proportions of patients where the bladder tumors are completely removed by one laser)	one month	Proportions of patients where the bladder tumors are completely removed by one laser treatment.

Trial Locations

Locations (1)

Department of Urology, Bispebjerg and Frederiksberg Hospital; 🇩🇰 Frederiksberg, Copenhagen, Denmark