Diagnostic Accuracy of SurePath™ in EUS-FNA

Submucosal Tumor of Gastrointestinal Tract Clinical Trial

Official title:

A Prospective Comparison of SurePath™ Liquid -Based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Esophageal, Gastric, Duodenal Subepithelial Tumors, Periesophageal and Perigastric Lymph Nodes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394129
• Other study ID #: 1902-076-1011
• Status: Recruiting
• Start date: April 9, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Han Myung Lee, M.D.
• Phone: 82-2-2072-2845
• Email: hmlee624[@]naver.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ulatrasound-guided sampling.

Description:

The SurePath™ has been approved by the FDA since 1997. Investigators want to compare the diagnostic accuracy of SurePath™ liquid based cytology and conventional smear cytology(CSC) in EUS-FNA sampling of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes. The investigators randomly assigned (1:1) patients to the SurePath™ group or the CSC group. Aspirates from the first needle pass were processed by one method, aspirates from the second pass by the other method, and specimens from the last pass were processed as core biopsy samples. The primary endpoint was the diagnostic efficacy of each method, with the final diagnosis as the gold standard. The aim of this study is to confirm that the SurePath™ is not inferior than the conventional smear test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients who signed the agreement after the explanation
• Patients suspected of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes from radiological(CT, MR, ultrasound) or endoscopic examinations.

Exclusion Criteria:

• Those who did not agree with the study
• Patients younger than 19 years of age
• Serious mental patients
• Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, sever mental illness)
• 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

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Submucosal Tumor of Gastrointestinal Tract

Intervention

Diagnostic Test:
• SurePath™
In the liquid-based cytology, a fine-needle 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	Pathologic results of the surgical specimen or core needle biopsy 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. The combined results make a final diagnosis and are compared between two groups.	6 months after randomization
Secondary	Cytomorphologic feature	We will evaluat the cytomorphologic features of each method. We plan to investigate whether there are differences in the level of artifacts, the degree of background cleanliness, and tumor cell characteristics such as cellularity.	6 months after randomization