Condition category
Cancer
Date applied
20/01/2009
Date assigned
10/02/2009
Last edited
14/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Beat Roth

ORCID ID

Contact details

Urologische Klinik
Inselspital
Bern
3010
Switzerland

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

http://www.insel.ch/

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

  1. 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.

Additional files

Editorial Notes