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

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Baylor College of Medicine

Status

Completed

Conditions

Pancreatic Neoplasms

Treatments

Procedure: Fine-Needle Biopsy (FNB)

Study type

Observational

Funder types

Other

Identifiers

NCT04165018
H-44963

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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