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

Sponsor

Baylor College of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04165018

Collaborator

(none)

200

Enrollment

Locations

19.7

Anticipated Duration (Months)

100

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms	Procedure: Fine-Needle Biopsy (FNB)

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 9, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

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

Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine	Houston	Texas	United States	77030
2	Baylor St. Lukes Medical Center (BSLMC)	Houston	Texas	United States	77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Othman, Principal Investigator, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT04165018

Other Study ID Numbers:

H-44963

First Posted:

Nov 15, 2019

Last Update Posted:

Oct 7, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Othman, Principal Investigator, Baylor College of Medicine

Pancreatic masses and lesions

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Oct 7, 2021