Lymphatic drainage of the urinary bladder in bladder cancer patients scheduled for cystectomy

ISRCTN	ISRCTN39379749
DOI	https://doi.org/10.1186/ISRCTN39379749
Protocol serial number	31/07
Sponsor	Inselspital, University Hospital Berne (Switzerland)
Funder	Inselspital, University Hospital Berne, Department of Urology (Switzerland)

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

Urologische Klinik
Inselspital
Bern
3010
Switzerland

Study information

Primary study design	Interventional
Study design	Interventional prospective single-arm single-centre study
Secondary study design	Single-centre
Study type	Participant 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(s)	Lymphatic drainage: regions of the different bladder sites
Key secondary outcome measure(s)	Reduction of lymph node dissection field
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	90 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes