Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
31/07
Study information
Scientific title
A multimodality technique of single photon emission computed tomography fused with computed tomography (SPECT-CT) and intraoperative verification by gamma probe used to map the primary lymphatic landing sites of the urinary bladder wall in patients scheduled for cystectomy
Acronym
Study hypothesis
Surgical excision and histological examination of the pelvic lymph nodes (LNs) provides the most accurate staging regarding pelvic lymph node status in patients undergoing radical cystectomy for invasive urinary bladder cancer. Whilst the optimal field of lymphadenectomy is still debated, there is growing evidence that extended pelvic lymph node dissection (PLND) in patients with bladder cancer may confer a survival benefit for both node-positive and node-negative patients. The purpose of this study was to prospectively determine the anatomical location of the draining LNs after injection with a radioactive tracer in the lateral, non tumour bearing bladder wall and to evaluate the implications for the extent of PLND in strictly unilateral bladder cancer.
Ethics approval
Ethics Committee of Bern, approved in February 2007 (ref: 31/07)
Study design
Interventional prospective single-arm single-centre study
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lymphatic drainage of urinary bladder in bladder cancer patients
Intervention
Preoperative flexible cystoscopy guided injection of technetium into the bladder wall in patients with bladder cancer scheduled for cystectomy and extended PLND. Thereafter, all patients undergo preoperative SPECT-CT to detect Tc 99m positive nodes. Intraoperative gamma probe detection at the time of PLND. Removal of Tc 99m positive nodes separately. Backup extended PLND to detect possibly missed Tc 99m positive nodes.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Lymphatic drainage: regions of the different bladder sites
Secondary outcome measures
Reduction of lymph node dissection field
Overall trial start date
01/03/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, age range: 18-90 years
2. Invasive urinary bladder cancer
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. T4 bladder cancer
2. Lymph node positive
3. Metastases seen on CT scan
4. Pregnancy
5. Previous operations to the pelvis
Recruitment start date
01/03/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Switzerland
Trial participating centre
Urologische Klinik
Bern
3010
Switzerland
Sponsor information
Organisation
Inselspital, University Hospital Berne (Switzerland)
Sponsor details
c/o Dr Beat Roth
Urologische Universitätsklinik
Inselspital
Bern
3010
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Inselspital, University Hospital Berne, Department of Urology (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19879039
Publication citations
-
Results
Roth B, Wissmeyer MP, Zehnder P, Birkhäuser FD, Thalmann GN, Krause TM, Studer UE, A new multimodality technique accurately maps the primary lymphatic landing sites of the bladder., Eur. Urol., 2010, 57, 2, 205-211, doi: 10.1016/j.eururo.2009.10.026.