Pancreatic Cancer
Conditions
Brief summary
The SurePathTM has been approved by the FDA since 1997. Currently, the SurePathTM is used for endometrial cells, body fluids, bronchoscopy aspirates, and thyroid fine needle aspirates. There is an advantage that the denaturation is small, the density of the cells is uniform, and the read area is small so that the read time can be shortened. Therefore, investigators plan to apply the SurePathTM test for pancreatic EUS-FNA specimens. Morphological comparative analysis is needed before completely replacing the existing classical smear test method. The aim of this study is to confirm that the SurePathTM is not inferior and is more accurate than the classical smear test.
Interventions
DIAGNOSTIC_TESTSurePathTM
In the liquid-phase cytology, a fine-aspirated sample is immediately inserted into a container containing a commercially available preservative solution without a separate slide-smearing procedure and immediately after the fine-needle aspiration.
Sponsors
Seoul National University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who signed the agreement after the explanation * Patients suspected of pancreatic cancer from radiological examinations (CT, MR, ultrasound)
Exclusion criteria
* Those who did not agree with the study * Patients older than 18 years of age * Serious mental patients * Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, poorly controlled blood sugar) * Pregnant women * If EUS is difficult due to previous surgery (Billroth II or TG with R-en-Y) * Patient with blood clotting abnormality * If there is a risk of tract seeding after examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | 6 months after randomization | If surgical treatment is performed after the examination, pathologic results of the surgical specimen and record will be checked whether it is malignancy or benign. If benign diagnosis is made by combining the results of SurePathTM and conventional smear test, the follow-up period is 6 months and the results of the 6-month follow-up imaging and additional biopsy are checked. Additional tests performed at this time are subject to the clinician's decision according to the clinical situation of each patient. The combined results make a final diagnosis and are compared between two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 6 months after randomization | The proportion of positives that are correctly identified as such. |
| Specificity | 6 months after randomization | The proportion of negatives that are correctly identified as such |
Countries
South Korea
Contacts
Primary ContactSang Hyub Lee, MD. PhD.
Backup ContactMin su You, MD
Outcome results
None listed