To compare a new endoscopic brush device with conventional brush cytology and compare the amount of cells obtained by the two different brushes
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* the feasibility of brushing with a new developed mesh brush (compared to
conventional brush)
* the amount of cells obtained with the new mesh brush and with conventional
brush
Secondary outcome
* the efficiency of the new brush device (time required to obtain brush
specimen).
* the quality of the obtained material for analysis with FISH-technique
(fluorescence in situ hybridisation).
* the material that remains for other techniques for DNA-, RNA- and
protein-analysis.
* any bleedings or discomfort leading to prolonged hospital
stay.
Background summary
Barrett*s esophagus is a pre-malignant condition and endoscopic surveillance
with systematic histological biopsies is recommended for follow up. Cytology
has a number of advantages compared to routine endoscopic biopsies in the
surveillance of Barrett*s esophagus; ability to sample a larger area and thus
reducing sampling error, preferential exfoliation of dysplastic cells, very low
risk of complications, simplicity, less time-consuming, and lower costs.
However, until recently histology might have had a higher rate to identify
Barrett patients at risk for progression to cancer, compared to cytology
diagnosis. Recently we developed a novel assay using biomarkers incombination
with cytology which efficiently identifies Barrett patients with a 5 to 9 time
increased risk to develop dysplasia or cancer (ref: UEGW, Stckholm Oct 2011
abstract Op050E). In this assay fluorescence in situ hybridisation (FISH) is
applied to cytology specimens as obtained during surveillance endoscopy. To
further improve this assay there*s a need to optimize the technique of brush
cytology by minimizing the sampling error. With a new developed mesh brush we
think we can safely and efficiently sample a larger area of the Barrett surface
and increase the likelihood of contact with the esophageal mucosa, which would
greatly reduce sampling errors. The balloon-shaped mesh brush functions as a
storage pool for the cells by which the amount of collected cells is highly
increased. A porcine study has already been performed, which showed a
substantial increase in cells obtained comparing a conventional endoscopy brush
with the novel device. Also the device was easily applied via the endoscopy and
did not cause any side effects or damage to the esophagus.
Study objective
To compare a new endoscopic brush device with conventional brush cytology and
compare the amount of cells obtained by the two different brushes
Study design
We will conduct a pilot study in which random patients with Barrett esophagus
who are undergoing routine upper endoscopy will be included. We will include
patients from February 2011 until September 2011. Apart from conventional brush
cytology also cytology will be obtained with a new designed endoscopic mesh
brush (developed by AMC and Cook and donated by Cook).
Study burden and risks
For this study we compared the conventional endoscopic brush cytology with a
newly designed device for endoscopic brush cytology which has shown good
results in a porcine study and no complications were reported during these
sessions. With this new endoscopic device we might be able to obtain more cells
in less time. We will include patients with Barrett*s esophagus and use both
the conventional brush and the new mesh brush in the same session. This means
that the endoscopic procedure might take some extra time, which will be no more
than five extra minutes. Other than this no extra tests or examinations will
take place. Endoscopic brush cytology has a very low risk of complications
(such as haemorrhage or bleeding).
Meibergdreef 9
1100 DD, Amsterdam
NL
Meibergdreef 9
1100 DD, Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with Barrett esophagus who will undergo already planned upper endoscopy for routinely surveillance purposes.
Exclusion criteria
Age under 18 year
Patients with ASA-score * 3
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 | NL38446.018.11 |