Prospective Study FNB, Is It Time To Abandon Cytological Assessment

Pancreatic Neoplasms Clinical Trial

— (FACET)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165018
• Other study ID #: H-44963
• Status: Completed
• Start date: April 9, 2021
• Est. completion date: October 10, 2023

Study information

• Verified date: October 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 10, 2023
• Est. primary completion date: April 6, 2023
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Baylor St. Lukes Medical Center (BSLMC)	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle		2 years
Secondary	Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation		2 years