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Completed

NCT Number: NCT04165018

Prospective Study FNB, Is It Time To Abandon Cytological Assessment

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor College of Medicine, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fine-Needle Biopsy (FNB)

Procedure

Fine-needle biopsy may be used to take samples of a pancreatic neoplasm.

Primary outcomes

  1. Sensitivity and Specificity using FNB sampling pancreatic mass

    Time frame: 2 years

    % of core tissue obtained, number of needle passes made, and assessment of any procedure related adverse events

  2. Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle

    Time frame: 2 years

Secondary outcomes

  1. Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Acronym: (FACET)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2019
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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