Plain English Summary
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 2019
Who is funding the study?
Lund University (Sweden)
Who is the main contact?
Dr Fredrik Liedberg
fredrik.liedberg@skane.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fredrik Liedberg
ORCID ID
http://orcid.org/0000-0001-8193-0370
Contact details
Department of Urology
Skåne University Hospital
Jan Waldenströmsgatan 5
Malmö
20502
Sweden
+46 40 33 10 00
fredrik.liedberg@skane.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Lymphadenectomy in urothelial carcinoma in the renal pelvis/calyces (LURP-study)
Acronym
LURP-study
Study hypothesis
This study aims to find where lymph node metastases are located in urothelial carcinomas of the upper urinary tract.
Ethics approval
The Ethics Board of Lund University, 09/06/2013, ref: 2013/321
Study design
Single-centre observational case series
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/01/2014
Overall trial end date
01/01/2019
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Clinical suspicion of non-muscle invasive UUTUC
Recruitment start date
01/01/2014
Recruitment end date
01/01/2019
Locations
Countries of recruitment
Sweden
Trial participating centre
Skåne University Hospital
Södra Förstadsgatan 101
Malmö
20502
Sweden
Funders
Funder type
University/education
Funder name
Lund University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication in a peer reviewed journal.
Intention to publish date
01/01/2020
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary