SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Pancreatic Lesions

Pancreatic Cancer Clinical Trial

Official title:

A Prospective Comparison of SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Pancreatic Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03606148
• Other study ID #: 1803-094-930
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

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