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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04165018
Recruitment Status : Not yet recruiting
First Posted : November 15, 2019
Last Update Posted : October 27, 2020
Information provided by (Responsible Party):
Mohamed Othman, 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.

Condition or disease Intervention/treatment
Pancreatic Neoplasms Procedure: Fine-Needle Biopsy (FNB)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 48 Weeks
Official Title: Prospective Study FNB, Is It Time To Abandon Cytological Assessment (FACET)
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Pancreatic mass biopsy for pathological evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to EUS-FNB for pancreatic mass lesions

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
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Responsible Party: Mohamed Othman, Principal Investigator, Baylor College of Medicine Identifier: NCT04165018    
Other Study ID Numbers: H-44963
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Othman, Baylor College of Medicine:
Pancreatic masses and lesions
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases