Plain English Summary
Background and study aims
Bladder cancer is one of the most common types of cancer. If the cancer if discovered early, the first step in the treatment is a procedure called a transurethral resection of the bladder tumor (TURB). In this procedure, the surgeon will locate the visible tumors and cut them away from the lining of the bladder. This is done by inserting a scope called a cystoscope into the bladder through the urethra (the tube that carries urine out of the body). Attached to this scope is a small, electrified loop of wire which is moved back and forth through the tumor to cut and remove the tissue. These tissue samples are then sent to a laboratory so that the tumor can be examined and graded. Although this procedure aims to remove the entire tumor and prevent them coming back (recurrence), the recurrence of tumors is common. A possible reason for this is that tumor cells are left behind (shedding) in this procedure, and are free to move to other places in the bladder to form new tumors. En-bloc resection is a technique where the surgeon removes the tumor in one piece. This could prevent the tumor cell shedding that may lead to tumor recurrence. The aim of this study is to find out whether en-bloc resection causes less tumor cell shedding than traditional TURB, and whether this reduces the overall risk of recurrence. The study also aims to find out if the tissue samples from en-bloc resection can help the pathologists in the laboratory in their analysis.
Who can participate?
Adults with newly diagnosed bladder cancer, with one to three bladder tumors between 1 and 3.5 cm in diameter.
What does the study involve?
Participants are randomly allocated into two groups. The first group are treated with the transurethral en-bloc resection of the bladder tumor (TUEBR) procedure, and the second group are treated with the conventional transurethral resection of the bladder tumor (TURB) procedure.
What are the possible benefits and risks of participating?
There are no known benefits or risks with the use of en-bloc resection compared to conventional TURB.
Where is the study run from?
1. Department of Urology, Skåne University Hospital (Sweden)
2. Department of Surgery, Urological section, Uddevalla Hospital (Sweden)
When is the study starting and how long is it expected to run for?
June 2013 to May 2020
Who is funding the study?
Research Council (Vetenskapsrådet) (Sweden)
Who is the main contact?
Dr Oliver Patschan
oliver.patschan@med.lu.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Oliver Patschan
ORCID ID
http://orcid.org/0000-0001-5788-794X
Contact details
Department of Urology
Skåne University Hospital
Lund University
Jan Waldenströms gata 5
Malmö
20502
Sweden
+46 40 332913
oliver.patschan@med.lu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Dnr 2013/23
Study information
Scientific title
Prospective randomised trial comparing transurethral en-bloc resection (TUEBR) with conventional transurethral resection (TURB) for bladder cancer
Acronym
Study hypothesis
This study aims to investigate whether en-bloc resection of newly diagnosed bladder cancer tumors might lead to less tumor cell implantation in the bladder than conventional TURB. This in turn might translate into a reduced frequency of recurrent tumors. En-bloc resection might also lead to more.
Ethics approval
Regionala Etikprövningsnämnd (Sweden), 05/02/2013, ref: 2013/23
Study design
Multi-centre prospective randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to requste a patient information sheet (only available in swedish).
Condition
Newly diagnosed bladder cancer (ICD10: C67.9)
Intervention
Participants are randomly allocated into the control group or the intervention group. The intervention group will undergo transurethral en-bloc resection of the bladder tumor (TUEBR), and the control group will undergo conventional transurethral resection of the bladder tumor (TURB).
For all patients: Follow up with cytology 4 weeks after operation. Cystoscopy and cytology 3, 6, 12, 18, 24, 36 months after operation, accordingly to our standard program.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Recurrence-free survival (RFS). For primary endpoint (recurrence) the time from operation to biopsy date, confirming the recurrence, is measured.
Secondary outcome measures
1. Interobserver variability of pathological stage. The histological slides from the primary operation are sent to 5 pathologists at the end of study. The tumorstage (Ta/T1/T2/Tis) is noted and the interobserver variability between groups is measured 3, 6, 12, 18, 24, 36 months after operation.
2. Urinary cytology after resection (normal, atypic or malign) is measured 3, 6, 12, 18, 24, 36 months after operation. An additional follow up with cytology will be 4 weeks after operation
Overall trial start date
01/01/2013
Overall trial end date
30/05/2022
Reason abandoned
Eligibility
Participant inclusion criteria
1. Newly diagnosed, suspected bladder cancer
2. Age 18 years or over
3. 1-3 bladder tumors
4. Tumor diameter between 1 and 3.5 cm
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. More than 3 tumors
2. Tumors larger than 3.5 cm
3. Solid tumors
4. Tumors with a large tumor base
5. Tumors in bladder diverticula
Recruitment start date
01/06/2013
Recruitment end date
30/05/2020
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Urology
Skåne University Hospital
Lund University
Jan Waldenströms gata 5
Malmö
20502
Sweden
Trial participating centre
Department of Surgery, Urological section
Urological Section
Department of Surgery
Uddevalla Hospital
Fjällvägen 9
Uddevalla
45180
Sweden
Sponsor information
Organisation
Skåne University Hospital
Sponsor details
Department of Urology
Skåne University Hospital
Jan Waldenströms gata 5
Malmö
20502
Sweden
+46-40-331000
oliver.patschan@med.lu.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Research Council (Vetenskapsrådet)
Alternative name(s)
Swedish Research Council, VR
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
Results and Publications
Publication and dissemination plan
Publication will be done on congresses (EAU, DGU, SUF) and hopefully in higher impact journals, since it is a prospective clinical trial. By now, it is extremely difficult to foresee the pace of the recruiting process, but I think it is realistic to publish preliminary data in 2017.
Intention to publish date
01/06/2017
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary