Condition category
Cancer
Date applied
09/09/2015
Date assigned
07/10/2015
Last edited
07/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

Institute Translational Medicine

Sponsor details

Lund University
Jan Waldenströms gata 35
Malmö
205 02
Sweden

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes