Laser Treatment of Bladder Tumors in the Outpatient Department
Primary Purpose
Bladder Tumors
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
TURBT
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Tumors
Eligibility 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
Sites / Locations
- Department of Urology, Bispebjerg and Frederiksberg Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TURBT
Arm Description
Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms)
Outcomes
Primary Outcome Measures
Complete Removal by One Laser Treatment (Proportions of patients where the bladder tumors are completely removed by one laser)
Proportions of patients where the bladder tumors are completely removed by one laser treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02659332
Brief Title
Laser Treatment of Bladder Tumors in the Outpatient Department
Official Title
Diode Laser Treatment of Pta Low Grade Bladder Tumors in the Outpatient Department
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gregers G Hermann
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TURBT
Arm Type
Experimental
Arm Description
Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of1ms)
Intervention Type
Device
Intervention Name(s)
TURBT
Intervention Description
Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of 1 ms)
Primary Outcome Measure Information:
Title
Complete Removal by One Laser Treatment (Proportions of patients where the bladder tumors are completely removed by one laser)
Description
Proportions of patients where the bladder tumors are completely removed by one laser treatment.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregers G Hermann, MD, DMSc
Organizational Affiliation
Bispebjerg and Frederiksberg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Bispebjerg and Frederiksberg Hospital
City
Frederiksberg
State/Province
Copenhagen
ZIP/Postal Code
2000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23485231
Citation
Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.
Results Reference
background
PubMed Identifier
15638895
Citation
Sangar VK, Ragavan N, Matanhelia SS, Watson MW, Blades RA. The economic consequences of prostate and bladder cancer in the UK. BJU Int. 2005 Jan;95(1):59-63. doi: 10.1111/j.1464-410X.2005.05249.x.
Results Reference
background
PubMed Identifier
19576682
Citation
van Rhijn BW, Burger M, Lotan Y, Solsona E, Stief CG, Sylvester RJ, Witjes JA, Zlotta AR. Recurrence and progression of disease in non-muscle-invasive bladder cancer: from epidemiology to treatment strategy. Eur Urol. 2009 Sep;56(3):430-42. doi: 10.1016/j.eururo.2009.06.028. Epub 2009 Jun 26.
Results Reference
background
PubMed Identifier
23540783
Citation
James AC, Gore JL. The costs of non-muscle invasive bladder cancer. Urol Clin North Am. 2013 May;40(2):261-9. doi: 10.1016/j.ucl.2013.01.004. Epub 2013 Feb 13.
Results Reference
background
PubMed Identifier
6894732
Citation
Hofstetter A, Frank F, Keiditsch E, Bowering R. Endoscopic Neodymium-YAG laser application for destroying bladder tumors. Eur Urol. 1981;7(5):278-82. doi: 10.1159/000473240.
Results Reference
background
PubMed Identifier
20615299
Citation
Davenport K, Keeley FX Jr, Timoney AG. Audit of safety, efficacy, and cost-effectiveness of local anaesthetic cystodiathermy. Ann R Coll Surg Engl. 2010 Nov;92(8):706-9. doi: 10.1308/003588410X12699663904835. Epub 2010 Jul 2.
Results Reference
background
PubMed Identifier
23537221
Citation
Syed HA, Talbot N, Abbas A, MacDonald D, Jones R, Marr TJ, Rukin NJ. Flexible cystoscopy and Holmium:Yttrium aluminum garnet laser ablation for recurrent nonmuscle invasive bladder carcinoma under local anesthesia. J Endourol. 2013 Jul;27(7):886-91. doi: 10.1089/end.2012.0696. Epub 2013 Jun 22.
Results Reference
background
PubMed Identifier
23819486
Citation
Wong KA, Zisengwe G, Athanasiou T, O'Brien T, Thomas K. Outpatient laser ablation of non-muscle-invasive bladder cancer: is it safe, tolerable and cost-effective? BJU Int. 2013 Sep;112(5):561-7. doi: 10.1111/bju.12216. Epub 2013 Jul 2.
Results Reference
background
PubMed Identifier
22150596
Citation
Hermann GG, Mogensen K, Toft BG, Glenthoj A, Pedersen HM. Outpatient diagnostic of bladder tumours in flexible cystoscopes: evaluation of fluorescence-guided flexible cystoscopy and bladder biopsies. Scand J Urol Nephrol. 2012 Feb;46(1):31-6. doi: 10.3109/00365599.2011.637954. Epub 2011 Dec 12.
Results Reference
background
PubMed Identifier
17116555
Citation
Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. J Am Coll Surg. 2006 Dec;203(6):865-77. doi: 10.1016/j.jamcollsurg.2006.08.026.
Results Reference
background
Learn more about this trial
Laser Treatment of Bladder Tumors in the Outpatient Department
We'll reach out to this number within 24 hrs