Evaluation of lymph node surgery in patients with upper urinary tract carcinoma

ISRCTN	ISRCTN83155790
DOI	https://doi.org/10.1186/ISRCTN83155790
Secondary identifying numbers	N/A

Submission date: 09/09/2015
Registration date: 07/10/2015
Last edited: 09/04/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The most common type of bladder cancer is transitional cell bladder cancer (TCC), also known as urothelial carcinoma. This type of bladder cancer starts in the cells that line the inside of the bladder (transitional cells), which are designed to expand when the bladder is full and contract when it is empty. These same cells also line the tubes which carry urine from the kidney to the bladder (ureter) and out of the body (urethra). Cancers of the upper urinary tract are most common in the renal pelvis (the part of the kidney that connects to the ureters) or the renal calyces (the part of the kidney where urine is collected). The main treatment for this is an operation called a nephroureterectomy, where the kidney and renal pelvis is removed. In some cases of urothelial carcinoma, the cancerous cells can spread around the body (metastases). In order to find out the extent of this an operation called a retroperitoneal lymphadenectomy is performed, in which the lymph nodes (swellings which produce white blood cells) are removed and examined. There is little evidence of nephroureterectomies and retroperitoneal lymphadenectomies being carried out at the same time. The aim of this study is to find out where lymph node metastases are located in urothelial carcinomas of the upper urinary tract.

Who can participate?
Adults with advanced urothelial carcinoma in Sweden.

What does the study involve?
At the time of surgery, the location of lymph node metastases is recorded in all patients. Over a two year follow up period, imagining is completed in order to find out if the lymph node metastases have returned. For 90 days after surgery, patients attend follow up appointments so that any surgical complications from the surgery can be recorded.

What are the possible benefits and risks of participating?
There are no specific benefits of participating in the study. There are no risks of participating other than the usual risks which accompany major surgery.

Where is the study run from?
Skåne University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
January 2015 to January 2028

Who is funding the study?
Lund University (Sweden)

Who is the main contact?
Dr Fredrik Liedberg
fredrik.liedberg@skane.se

Contact information

Dr Fredrik Liedberg
Scientific

Department of Urology
Skåne University Hospital
Jan Waldenströmsgatan 5
Malmö
20502
Sweden

ORCID ID	0000-0001-8193-0370
Phone	+46 40 33 10 00
Email	fredrik.liedberg@skane.se

Study information

Study design	Single-centre observational case series
Primary study design	Observational
Secondary study design	Case series
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Lymphadenectomy in urothelial carcinoma in the renal pelvis/calyces (LURP-study)
Study acronym	LURP-study
Study objectives	This study aims to find where lymph node metastases are located in urothelial carcinomas of the upper urinary tract.
Ethics approval(s)	The Ethics Board of Lund University, 09/06/2013, ref: 2013/321
Health condition(s) or problem(s) studied	Urothelial carcinoma of the upper urinary tract
Intervention	At the time the retroperitoneal lymphadenectomy is performed on the participants, the location of the lymph node metastases is recorded. The participants are then monitored for 90 days post-surgery for post-surgical complications. After two years, using radiological methods, the location of any further metastases are recorded.
Intervention type	Procedure/Surgery
Primary outcome measure	Location of lymph node metastasis measured at retroperitoneal lymphadenectomy during follow up if the patients suffer from lymph node recurrence, within a two year period.
Secondary outcome measures	Post surgical complications are monitored throughout 90 days after surgery, by examining patient charts. After 90 days, a Clavien score between 0 and 5 is determined.
Overall study start date	01/01/2014
Completion date	01/01/2028

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key inclusion criteria	1. Aged 18 years or over 2. Locally advanced high grade urothelial carcinoma in the renal pelvis or upper 2/3 of the ureter (Clinical stage > T1)
Key exclusion criteria	Clinical suspicion of non-muscle invasive UUTUC
Date of first enrolment	01/01/2014
Date of final enrolment	01/03/2027

Locations

Countries of recruitment

Norway
Sweden

Study participating centres

Skåne University Hospital

Södra Förstadsgatan 101
Malmö
20502
Sweden

St Olavs University Hospital of Trondheim

Department of Urology
-
Norway

Sponsor information

Lund University
University/education

Institute Translational Medicine
Jan Waldenströms gata 35
Malmö
205 02
Sweden

Website	http://www.lunduniversity.lu.se/
"ROR"	https://ror.org/012a77v79

Funders

Funder type

University/education

Lund University

No information available

Results and Publications

Intention to publish date	01/01/2030
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	Publication in a peer reviewed journal.
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Editorial Notes

09/04/2025: The recruitment end date was changed from 01/01/2026 to 01/03/2027.
10/01/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2024 to 01/01/2026.
2. The overall end date was changed from 01/01/2026 to 01/01/2028.
3. The intention to publish date was changed from 01/01/2027 to 01/01/2030.
4. The plain English summary was updated to reflect these changes.
20/01/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2021 to 01/01/2024.
2. The overall end date was changed from 01/01/2023 to 01/01/2026.
3. The intention to publish date was changed from 01/01/2024 to 01/01/2027.
4. The plain English summary was updated to reflect these changes.
22/01/2020: Internal review.
15/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2019 to 01/01/2021.
2. The overall trial end date was changed from 01/01/2019 to 01/01/2023.
3. St Olavs University Hospital of Trondheim was added as a trial participating centre.