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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03606148
Other study ID # 1803-094-930
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 17, 2018
Est. completion date December 31, 2019

Study information

Verified date April 2018
Source Seoul National University Hospital
Contact Sang Hyub Lee, MD. PhD.
Phone +82-2-2072-4892
Email gidoctor@snuh.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 170
Est. completion date December 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
SurePathTM
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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy 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. 6 months after randomization
Secondary Sensitivity The proportion of positives that are correctly identified as such. 6 months after randomization
Secondary Specificity The proportion of negatives that are correctly identified as such 6 months after randomization
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