To determine whether prostate biopsies processed with the SmartBX system result in more and better interpretable material.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
loss of biopsy core length during processing (length on needle - length on
pathology slide) compared between the SmartBX system and the traditional method
of shaking the biopsy cores into formalin jars.
Secondary outcome
none
Background summary
In Patients with a clinical suspicion of prostate cancer, prostate biopsies are
often required to confirm or reject the diagnosis. After taking the biopsy
core, it is normally shaken from the biopsy needle into a formalin jar. This
causes fragmentation of the cores, loss of material and the orientation of the
specimen within the prostate is lost. The fragments must be removed from the
jars, straightened, and put embedded in paraffin. This is a time consuming and
therefore costly process. WIth the SmartBX system the biopsy specimen is
downloaded from the biopsy needle in a cartridge with a special paper. This
preserves all the biopsy material, reduces fragmentation and preserves the
orientation of the specimen. The processing of the specimen requires less
handling which saves time and money.
Study objective
To determine whether prostate biopsies processed with the SmartBX system result
in more and better interpretable material.
Study design
In 60 patients, half the biopsies will be processed in the traditional way and
half the biopsies with the SmartBX system. Randomization will determine which
side of the prostate will be done with which method. The length of the biopsy
core is recorded on the biopsy needle with a camera. the length of the biopsy
specimen is again measured on the final pathology slide used for
interpretation. We then determine whether the cores processed with the SmartBX
system suffer from more or less loss of length during processing.
Study burden and risks
No burden. The same amount of biopsy cores will be taken, from the normal
locations using the same technique and equipment. normally all biopsies are
shaken of the needle into a formalin jar. Now half of the biopsy cores are
taken of the needle using the SmartBx system. The only risk to the patient is
that the cores processed with the SmartBx end up being less well
interpret-able. This is very unlikely based on previous research and our own
experiences with the system. The ultimate consequence of un interpretable
material would be that the participant would have to have half of the prostate
biopsies (left or right lobe determined by randomization) retaken.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
referred for prostate biopsies
Exclusion criteria
age below 18
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52856.018.15 |