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

NCT03606148 | Unknown

• 1 other identifier: 1803-094-930
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sensitivity

  6 months after randomization

• Specificity

  6 months after randomization

Study Arms (2)

SurePathTM

The subjects are randomly assigned to SurePathTM/Conventional test group at a ratio of 1: 1. In SurePathTM group, subjects who underwent SurePathTM liquid-phase cytology test with the first sample subjected to the conventional smear test with the second sample.

Diagnostic Test: SurePathTM

Conventional

The subjects are randomly assigned to SurePathTM/Conventional test group at a ratio of 1: 1. In conventional test group, those who subjected to the conventional smear test with the first sample, will undergo the SurePathTM liquid cell test with the second obtained sample.

Diagnostic Test: SurePathTM

Interventions

SurePathTM DIAGNOSTIC_TEST

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.

Conventional; SurePathTM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients above 18 years of age who underwent EUS-FNA for suspected pancreatic cancer based on imaging fingings.

You may qualify if:

• Patients who signed the agreement after the explanation
• Patients suspected of pancreatic cancer from radiological examinations (CT, MR, ultrasound)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (1)

• Chun JW, Lee K, Lee SH, Kim H, You MS, Hwang YJ, Paik WH, Ryu JK, Kim YT. Comparison of liquid-based cytology with conventional smear cytology for EUS-guided FNA of solid pancreatic masses: a prospective randomized noninferiority study. Gastrointest Endosc. 2020 Apr;91(4):837-846.e1. doi: 10.1016/j.gie.2019.11.018. Epub 2019 Nov 20.

  PMID: 31759036 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Sang Hyub Lee, MD. PhD.

CONTACT

+82-2-2072-4892; gidoctor@snuh.org

Min su You, MD

CONTACT

+82-2-2072-3168; bass105@hanmail.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: July 30, 2018
• Study Start: April 17, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 23, 2019

Record last verified: 2018-04

Locations

KR (1)