Prospective Study FNB, Is It Time To Abandon Cytological Assessment

Completed

• Conditions: Pancreatic Neoplasms

• Registration Number: NCT04165018
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Study Start: 2021-04-09
• Primary Completion: 2023-04-06
• Status Verified: 2023-10
• Study Completion: 2023-10-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation	2 years

Trial Locations

Locations (2)

Baylor St. Lukes Medical Center (BSLMC); 🇺🇸 Houston, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States