Diagnostic Accuracy of SurePath™ in EUS-FNA

Seoul National University Hospital89 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Submucosal Tumor of Gastrointestinal Tract

Interventions

SurePath™DIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 6 months after randomization

Secondary Outcomes

Cytomorphologic feature

The investigators will evaluate the cytomorphologic features of each method. The investigators plan to investigate whether there are differences in the level of artifacts, the degree of background cleanliness, and tumor cell characteristics such as cellularity.

Time frame: 6 months after randomization

Data from ClinicalTrials.gov

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