SAGA-trial - investigating if intraoperative sterile water irrigation during an operation to remove the kidney due to cancer (nephroureterectomy for upper tract urothelial carcinoma) decreases the risk of tumor recurrence.
| ISRCTN | ISRCTN18038733 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18038733 |
- Submission date
- 30/08/2021
- Registration date
- 07/10/2021
- Last edited
- 19/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Upper tract urothelial carcinoma is a type of cancer that affects the tubes connected to the kidney. Nephroureterectomy is surgery to remove the affected area. There is a risk of tumor recurrence. We aim to investigate if sterile water irrigation of the area during surgery decreases that risk.
Who can participate?
Patients aged 18 years old or above with upper tract urothelial carcinoma treated by nephroureterectomy.
What does the study involve?
Participants will be randomly allocated to receive sterile water irrigation during surgery or surgery as usual. Patients will be followed up for 2 years.
What are the possible benefits and risks of participating?
There are no risks of participating, but a chance to decrease the risk of later intravesical tumor recurrence if the study hypothesis is correct.
Where is the study run from?
Skåne University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
May 2021 to September 2027
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof Fredrik Liedberg, fredrik.liedberg@med.lu.se
Contact information
Scientific
Department of Urology, Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
205 02
Sweden
 ORCID ID |
0000-0001-8193-0370 |
|---|---|
| Phone | +46-40-331000 |
| fredrik.liedberg@med.lu.se |
Study information
| Study design | Prospective multicenter randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40346 PIS 18May2021.pdf |
| Scientific title | Sterile water irrigation at nephroureterectomy for upper tract urothelial carcinoma: a study on the effect on bladder tumour recurrence |
| Study acronym | SAGA-trial |
| Study objectives | Intraoperative bladder irrigation with sterile water at nephroureterectomy decreases risk of bladder tumour recurrence. |
| Ethics approval(s) | Approved 21/06/2021, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: EPM Dnr: 2021-02919 |
| Health condition(s) or problem(s) studied | Upper tract urothelial carcinoma |
| Intervention | Control arm = no additional treatment during nephroureterectomy Intervention arm = sterile water irrigation during nephroureterectomy Randomization by sealed envelopes Follow up for 2 years |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Bladder cancer recurrence measured by cystoscopy up to 2 years after the operation |
| Secondary outcome measures | 1. Quality of life assessed by EORTC QLQ 30 NMIBC six weeks after nephroureterectomy 2. Bladder cancer progression free survival as assessed at end of 2 years 3. Quality of life measured using EQ-5D-5L at six weeks after nephroureterectomy |
| Overall study start date | 01/05/2021 |
| Completion date | 15/09/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. 18 years old or above 2. Upper tract urothelial carcinoma treated by nephroureterectomy. |
| Key exclusion criteria | 1. Lack of informed consent 2. Below 18 years of age |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Helsingborg
252 23
Sweden
Malmö
205 02
Sweden
Sponsor information
Hospital/treatment centre
Dept. of Urology
Jan Waldenstömsgata 5
Malmö
205 02
Sweden
| Phone | +46-40-331000 |
|---|---|
| anki.rosberg@med.lu.se | |
| Website | http://www.skane.se/sv/Webbplatser/Skanes-universitetssjukhus/ |
"ROR" |
https://ror.org/02z31g829 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 18/05/2021 | 01/09/2021 | No | Yes |
Additional files
Editorial Notes
19/12/2024: The recruitment end date was changed from 15/09/2025 to 31/12/2026.
07/11/2023: The contact confirmed the record is up to date.
01/09/2021: Trial's existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)
