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Trial record 53 of 130 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT03606148
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment
Pancreatic Cancer Diagnostic Test: SurePathTM

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 170 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Prospective Comparison of SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Pancreatic Lesions
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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

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
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.




Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 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 Outcome Measures :
  1. Sensitivity [ Time Frame: 6 months after randomization ]
    The proportion of positives that are correctly identified as such.

  2. Specificity [ Time Frame: 6 months after randomization ]
    The proportion of negatives that are correctly identified as such



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients above 18 years of age who underwent EUS-FNA for suspected pancreatic cancer based on imaging fingings.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606148


Contacts
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Contact: Sang Hyub Lee, MD. PhD. +82-2-2072-4892 gidoctor@snuh.org
Contact: Min su You, MD +82-2-2072-3168 bass105@hanmail.net

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sang Hyub Lee, MD. PhD    +82-2-2072-4892    gidoctor@snuh.org   
Sponsors and Collaborators
Seoul National University Hospital

Additional Information:

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03606148     History of Changes
Other Study ID Numbers: 1803-094-930
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No