Primary Objective: - The ability of SFR spectroscopy incorporated in EUS-FNA procedure in distinguishing benign and malignant pancreatic tissue by measuring wavelength dependent optical characteristics over a broad wavelength range (400-1000 nm).…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Health condition
pancreas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The shape of the spectra and the optical absorption coefficients over a broad
wavelength range will be used to distinguish pancreatic tumors and benign
pancreatic tissue. To extract and quantify physiological information from the
obtained spectra, such as blood volume fraction and tissue oxygenation, a
validated mathematical model, based on the knowledge of the absorption spectra
of the chromophores, will be used. Therefore, we need to determine the serum
bilirubin and hemoglobin, before the EUS-FNA is performed, which is part of
the clinical workflow ('zorgpad pancreas'). The obtained spectra will be linked
to final cytological analysis.
Secondary outcome
The diagnostic accuracy (including sensitivity, specificity, negative
predictive value and positive predictive value) of one or more combined
wavelengths specific for pancreatic tumor tissue will be calculated after
comparison to cytological and final diagnosis.
Background summary
Even with the current imaging modalities there are still limitations in the
diagnosis of pancreatic cancer. EUS-FNA is the least invasive and most
effective procedure in diagnosing pancreatic tumors. A disadvantage of EUS-FNA
is the relatively long period, approximately three weeks between procedure and
diagnosis of the pancreatic mass and the lack of specificity, which sometimes
requires the EUS-FNA procedure to be repeated. A novel technique in detecting
tumor tissue is Single Fiber Reflectance (SFR) spectroscopy, which could be
incorporated in the EUS-FNA procedure to detect pancreatic masses. It is an
optical imaging technique, capable of extracting reflectance spectra from
endogenous chromophores from a very small tissue volume. In a feasibility study
of our group, SFR spectroscopy showed an accurate correlation between cytology
in 9 patients with a pancreatic mass (3 benign vs 6 malignant). Moreover, the
oxygen saturation and bilirubin concentration differs significantly between
normal and malignant tissue (55% vs. 21%, p=0.038; 166 µmol/L vs. 17 µmol/L,
p=0.039, respectively). In this study SFR spectroscopy, incorporated in the
EUS-FNA procedure, will be evaluated to increase the diagnostic accuracy and to
facilitate the diagnosis of pancreatic cancer.
Study objective
Primary Objective:
- The ability of SFR spectroscopy incorporated in EUS-FNA procedure in
distinguishing benign and malignant pancreatic tissue by measuring wavelength
dependent optical characteristics over a broad wavelength range (400-1000 nm).
Secondary Objective:
- Selection of wavelengths specific for pancreatic tumor detection and
evaluation of its diagnostic accuracy compared to cytological diagnosis.
Study design
This study is designed as a prospective observational multicenter study.
Study burden and risks
There is no benefit for the individual patient upon participation to this
study. The benefit will concern a large amount of the future pancreatic cancer
population. However, there are also minimal risks for the patients
participating in this study. The use of sterile products minimises the risk of
infection, during the procedure. Measurements are taken only in tissue that
will directly afterwards be removed, to avoid potential spread of tumor cells
to normal pancreatic tissue. The burden is also minimal: the patients are
already subjected to the EUS-FNA procedure. The total additional time of the
measurements is expected to be 10 minutes.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Patients scheduled for EUS-FNA, due to a suspect lesion of the pancreas
Exclusion criteria
- Patients with age under 18 years
- Patients who object to participate in this study.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL63777.058.17 |