Lymphatic drainage of the urinary bladder in bladder cancer patients scheduled for cystectomy
| ISRCTN | ISRCTN39379749 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39379749 |
| Secondary identifying numbers | 31/07 |
- Submission date
- 20/01/2009
- Registration date
- 10/02/2009
- Last edited
- 14/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Beat Roth
Scientific
Scientific
Urologische Klinik
Inselspital
Bern
3010
Switzerland
Study information
| Study design | Interventional prospective single-arm single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethics Committee of Bern, approved in February 2007 (ref: 31/07) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Lymphatic drainage: regions of the different bladder sites |
| Secondary outcome measures | Reduction of lymph node dissection field |
| Overall study start date | 01/03/2007 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Both males and females, age range: 18-90 years 2. Invasive urinary bladder cancer 3. Informed consent |
| Key exclusion criteria | 1. T4 bladder cancer 2. Lymph node positive 3. Metastases seen on CT scan 4. Pregnancy 5. Previous operations to the pelvis |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Urologische Klinik
Bern
3010
Switzerland
3010
Switzerland
Sponsor information
Inselspital, University Hospital Berne (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Beat Roth
Urologische Universitätsklinik
Inselspital
Bern
3010
Switzerland
| Website | http://www.insel.ch/ |
|---|---|
"ROR" |
https://ror.org/01q9sj412 |
Funders
Funder type
Hospital/treatment centre
Inselspital, University Hospital Berne, Department of Urology (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2010 | Yes | No |
