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Laser Treatment of Bladder Tumors in the Outpatient Department

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ClinicalTrials.gov Identifier: NCT02659332
Recruitment Status : Unknown
Verified January 2016 by Gregers G Hermann, Bispebjerg Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : January 20, 2016
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Gregers G Hermann, Bispebjerg Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bladder Tumors Device: TURBT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department
Study Start Date : February 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: TURBT
Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms)
 Device: TURBT
Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of 1 ms)


Outcome Measures
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Primary Outcome Measures :
  1. Complete Removal by One Laser Treatment (Proportions of patients where the bladder tumors are completely removed by one laser) [ Time Frame: one month ]
    Proportions of patients where the bladder tumors are completely removed by one laser treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659332


Locations
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Denmark
Department of Urology, Bispebjerg and Frederiksberg Hospital
Frederiksberg, Copenhagen, Denmark, 2000
Sponsors and Collaborators
Gregers G Hermann
Investigators
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Principal Investigator: Gregers G Hermann, MD, DMSc Bispebjerg and Frederiksberg Hospital
More Information
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Publications:

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Responsible Party: Gregers G Hermann, MD, DM Sc., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02659332    
Other Study ID Numbers: URU05
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases