To determine whether a low-dosage, digital X-ray scanning (LODOX-Statscan) can detect kidney stones in order to reduce radiation dosage

ISRCTN	ISRCTN12915426
DOI	https://doi.org/10.1186/ISRCTN12915426
Secondary identifying numbers	N/A

Submission date: 13/11/2014
Registration date: 10/12/2014
Last edited: 23/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Kidney stones are stone-like lumps that can develop in one or both of the kidneys. We are carrying out a study of 30 patients presenting in the emergency department for kidney stones. We want to find out whether a technique of X-ray scanning requiring only about one-third of the radiation dose used for normal X-ray, called LODOX, can detect kidney stones. Our goal is to eventually reduce the radiation dosage needed for kidney stone detection and follow-up.

Who can participate?
Adults over 18, presenting in our emergency department for kidney stones.

What does the study involve?
Patients receive a LODOX-Statscan in our emergency department after the existence of kidney stones has been proved by computed tomography (CT) scan.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part, but if our study shows that kidney stones really can be found by LODOX-Statscan, in future a LODOX could replace the conventional radiography. This means that future patients will benefit from the lower radiation dosage of the LODOX. Radiation dosage is an issue because radiation is known for its potential of causing cancer. The main risk is the additional radiation dose of the LODOX. However, the dose is very small.

Where is the study run from?
The study has been set up by the Urology Department of the University of Bern (Switzerland).

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in November 2014. Participants will be enrolled on the study for a period of six months.

Who is funding the study?
University Clinic of Urology (Urologische Universitaetsklinik) (Switzerland).

Who is the main contact?
Dr Stefanie Hnilicka
urology.berne@insel.ch

Contact information

Dr Stefanie Hnilicka
Scientific

Anna-Seiler-Haus
Inselspital
Bern
3010
Switzerland

Study information

Study design	Pilot study
Primary study design	Observational
Secondary study design	Other
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	A pilot study to evaluate if low-dosage, digital X-ray scanning (LODOX-Statscan) can detect ureteral stones
Study acronym	N/A
Study objectives	It is hypothesised that ureteral stones are visible in low-dosage, digital X-ray scanning (LODOX-Statscan) and that stone detection with LODOX is superior compared to conventional radiography while requiring lower radiation dosage.
Ethics approval(s)	Ethical Committee of the Canton Bern, Switzerland, 11/2013, ref: 156/12
Health condition(s) or problem(s) studied	Kidney and ureteral stones/reducing radiation dosage
Intervention	CT scan in all patients. A low-dosage, digital X-ray scanning (LODOX-Statscan) requiring a radiation dose of about 80 µSv will be performed in all participants. Total duration of intervention: approximately 5 minutes.
Intervention type	Other
Primary outcome measure	Stone detection rate by LODOX
Secondary outcome measures	1. Reducing radiation dosage 2. Comparability of stone size measured in LODOX, CT and conventional radiography 3. Fine-tuning adjustment of LODOX
Overall study start date	20/11/2014
Completion date	20/05/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Total final enrolment	41
Key inclusion criteria	1. Patients with kidney or ureteral stones proved by computed tomography (CT) 2. > 18 years 3. Written informed consent
Key exclusion criteria	1. Persistent, analgetic resistant pain 2. Pregnancy
Date of first enrolment	20/11/2014
Date of final enrolment	20/05/2015

Locations

Countries of recruitment

Switzerland

Study participating centre

Anna-Seiler-Haus

Bern
3010
Switzerland

Sponsor information

University Clinic of Urology (Urologische Universitaetsklinik) (Switzerland)
University/education

c/o Dr Stefanie Hnilicka
Inselspital
Bern
3010
Switzerland

"ROR"	https://ror.org/01q9sj412

Funders

Funder type

University/education

University Clinic of Urology (Urologische Universitaetsklinik) (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2020	06/06/2019	Yes	No

Editorial Notes

23/10/2020: Internal review.
06/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.