Prospective Study FNB, Is It Time To Abandon Cytological Assessment

Completed

Conditions studied: Pancreatic Neoplasms

In brief

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.

Key facts

Study ID

NCT04165018

Run by

Baylor College of Medicine

People needed

52

Starts

2021-04-09

Expected to finish

2023-10-10

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is greater than or equal to 18 years of age
• Patient is referred to EUS-FNB for pancreatic mass lesions

You may not qualify if…

• Patient is younger than 18 years of age
• Patient refused and/or unable to provide consent
• Patient is a pregnant woman

Where it is running

• Baylor College of Medicine — Houston, Texas, United States
• Baylor St. Lukes Medical Center (BSLMC) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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