En-bloc resection for bladder cancer
| ISRCTN | ISRCTN16837985 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16837985 |
| Secondary identifying numbers | Dnr 2013/23 |
- Submission date
- 25/08/2015
- Registration date
- 23/09/2015
- Last edited
- 19/06/2023
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Department of Urology
Skåne University Hospital
Lund University
Jan Waldenströms gata 5
Malmö
20502
Sweden
 ORCID ID |
0000-0001-5788-794X |
|---|---|
| Phone | +46 40 332913 |
| oliver.patschan@med.lu.se |
Study information
| Study design | Multi-centre prospective randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to requste a patient information sheet (only available in swedish). |
| Scientific title | Prospective randomised trial comparing transurethral en-bloc resection (TUEBR) with conventional transurethral resection (TURB) for bladder cancer |
| Study objectives | 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(s) | Regionala Etikprövningsnämnd (Sweden), 05/02/2013, ref: 2013/23 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2013 |
| Completion date | 30/05/2022 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Total final enrolment | 16 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 30/05/2020 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Lund University
Jan Waldenströms gata 5
Malmö
20502
Sweden
Department of Surgery
Uddevalla Hospital
Fjällvägen 9
Uddevalla
45180
Sweden
Sponsor information
Hospital/treatment centre
Department of Urology
Skåne University Hospital
Jan Waldenströms gata 5
Malmö
20502
Sweden
| Phone | +46-40-331000 |
|---|---|
| oliver.patschan@med.lu.se | |
| Website | http://www.enblocstudy.weebly.com |
"ROR" |
https://ror.org/02z31g829 |
Funders
Funder type
Not defined
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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. |
| IPD sharing plan |
Editorial Notes
19/06/2023: The study was stopped because the recruitment process was too slow. The obtained data does neither allow any statistical analysis nor any conclusions to be drawn.
