Prospective Study FNB, Is It Time To Abandon Cytological Assessment

Study Overview
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Brief Summary
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Endoscopic Ultrasound (EUS) is a minimally invasive procedure used by gastroenterologists to examine pancreatic masses and lesions. A fine needle is traversed through an endoscope and used to acquire tissue samples, which are then sent for pathology. The standard approach for diagnosing solid pancreatic lesions has been fine needle aspiration (FNA) (Han et al. 2016). However, the use of FNA comes with its limitations, some of which include multiple needle passes to acquire fluid, the need for on-site cytologists, and decreased diagnostic yield. Fine needle biopsy (FNB) is the latest approach being employed by endosonographers in lieu of FNA. FNB confers several advantages over FNB. First, FNB requires fewer needle passes than FNA to acquire tissue sample for immunohistochemical staining. In addition, FNB provides better tissues samples, greater sensitivity of the tissue core, and thus, improved diagnostic yields (Tian et al. 2018). Finally, FNB is more cost-effective than FNA and relies on pathologists, instead of on-site cytologists, and preserves the tissue core (Tian et al. 2018). The objective of this study is to establish a database of samples placed in formalin for patients who will undergo a fine-needle biopsy (FNB) for pathological evaluation without rapid on site cytological assessment.

Official Title
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Prospective Study FNB, Is It Time To Abandon Cytological Assessment (FACET)

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Procedure: Fine-Needle Biopsy (FNB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is greater than or equal to 18 years of age Patient is referred to EUS-FNB for pancreatic mass lesions Exclusion Criteria: Patient is younger than 18 years of age Patient refused and/or unable to provide consent Patient is a pregnant woman

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Fine-Needle Biopsy (FNB)|Fine-needle biopsy may be used to take samples of a pancreatic neoplasm.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity using FNB sampling pancreatic mass | % of core tissue obtained, number of needle passes made, and assessment of any procedure related adverse events | 2 years | 
| Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic masses and lesions