CompletedNot Applicable

Clinical Validation of an Immunocytochemistry Method Using MARS1

South Korea55 participantsStarted 2021-02-04

Plain-language summary

The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to validate the clinical usefulness of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer-related protein expressed only in bile duct cancer.

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography) * Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy * Patients who underwent surgical treatment with biliary cancer * Patients with bile duct stenosis Exclusion Criteria: * Minors under the age of 19, vulnerable subjects such as illiteracy * Necrotic specimens * Samples with non-diagnostic cytology results and insufficient cells for further evaluation * Samples classified as neoplastic (benign or other) * Patient with cholangitis in the bile duct

What they're measuring

The usefulness of new staining method

Timeframe: 1 year

Trial details

NCT IDNCT04759794

SponsorGangnam Severance Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-03

View on ClinicalTrials.gov More Bile Duct Obstruction, Extrahepatic trials