Primary Objective: Evaluation of the potential of the incorporated SFR spectroscopy into the EUS-FNA procedure to discriminate benign and malignant pancreas tissue in vivo.Secondary Objective: To measure the wavelength dependent differences in…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Health condition
Pancreasafwijkingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Shape of the spectra obtained from spectroscopy, optical absorption coefficient
of the different types of pancreatic tissue, cytological results and the
endosonographic images during the EUS-FNA procedure and during the surgery.
Secondary outcome
Patient characteristics: age, diagnosis, tumour size.
Background summary
Pancreatic cancer is the fourth leading cause of cancer deaths, leading to
227.000 deaths worldwide yearly. The five year survival rate is only 4%.
Approximately 1750 new patients were diagnosed with pancreatic cancer in The
Netherlands in 2006. Late detection is the most important cause for the low
survival percentage, because pancreatic cancer is mainly presented by
clinically silent symptoms[1]. In case of presenting symptoms, abdominal pain
or mid-back pain, weight loss and jaundice are reported[2].
The misdiagnosis of pancreatic tumours can be avoided by preoperative biopsies,
ultrasound (US), computed tomography (CT), endoscopic retrograde
cholangiopancreatography (ERCP), or by endoscopic ultrasound-guided fine needle
aspiration (EUS-FNA). In recent literature, the sensitivity and specificity of
EUS-FNA vary widely, sensitivity of 92% (95% CI = 91-92%, p < 0.001) and
specificity of 96% (95% CI = 93-98%, p = 0.006)respectively[3]. The
disadvantage of EUS-FNA are the long period, approximately three weeks between
procedure and diagnosis of the pancreatic mass and many procedures need to be
repeated, because the results, based on aspirated cytology, are not reliable
enough.
A novel alternative method to assess pancreatic tumours is EUS-FNA with an
incorporated fiber optical reflectance device, Single Fiber Reflectance (SFR)
spectroscopy. SFR is capable of extracting biologically relevant parameters,
believed to be relevant for cancer diagnosis, from a very small tissue volume.
Reflectance spectra obtained by SFR spectroscopy contain information about
tissue absorption and scattering properties. To facilitate measurements of
these parameters during endoscopic ultrasound guided fine needle aspiration
procedures, we will use a fiberoptic probe that fits in the needle of a
standard EUS-FNA device[4].
Similar procedures have been tested clinically in mamma carcinoma, cerebral
carcinomas and mediastinal lymph nodes at the Erasmus MC, Rotterdam, The
Netherlands. These results showed a significantly reduced oxygen saturation in
tumours compared to normal tissue. [4, 5] In the proposed study, we will extend
these measurements to pancreatic masses during an EUS-FNA procedure. It is
important to obtain measurements in healthy pancreatic tissue as well, in order
to compare them to measurements in tumor tissue. Therefor we will perform
measurements in the same patients during surgery as well.
References
1. Vincent, A., et al., Pancreatic cancer. The Lancet. 378(9791): p. 607-620
2. Petersen, G.M., et al., Pancreatic Cancer Genetic Epidemiology Consortium.
Cancer Epidemiology Biomarkers & Prevention, 2006. 15(4): p. 704-710
3. Chen, J., et al., Diagnostic accuracy of endoscopic ultrasound-guided
fine-needle aspiration for solid pancreatic lesion: a systematic review. J
Cancer Res Clin Oncol, 2012. 138(9): p. 1433-41
4. Kanick SC, v.d.L.C., Aerts JG, Hoogsteden HC, Kascáková S, Sterenborg HJ,
Amelink A, Integration of single-fiber reflectance spectroscopy into
ultrasound-guided endoscopic lung cancer staging of mediastinal lymph nodes. J
Biomed Opt, 2010. 15(1)
5. Kanick SC, v.d.L.C., Djamin RS, Janssens AM, Hoogsteden HC, Sterenborg HJ,
Amelink A, Aerts JG, Characterization of mediastinal lymph node physiology in
vivo by optical spectroscopy during endoscopic ultrasound-guided fine needle
aspiration. J Thorac Oncol, 2010. 5(7): p.981-7
Study objective
Primary Objective:
Evaluation of the potential of the incorporated SFR spectroscopy into the
EUS-FNA procedure to discriminate benign and malignant pancreas tissue in vivo.
Secondary Objective:
To measure the wavelength dependent differences in optical properties between
benign and malignant pancreatic tissue over a broad wavelength range (400-900
nm).
Study design
Feasibility study
Study burden and risks
No additional risks, besides the standard risks for EUS-FNA and pancreatic
surgery, are associated with participation. The burden and risks associated
with participation are minimal; optical measurements are performed with sterile
optical fibers. Measurements are only taken in tissue that will be removed by
cytology or surgery. The total time taken by the measurements is less than 10
minutes for each procedure, so less than 20 minutes in total.. The patients
will not benefit from the study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Patients with a pancreatic mass undergoing EUS-FNA and pancreatic surgery.
Exclusion criteria
Objection to participation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL46072.058.13 |