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.
ClinicalTrials.gov Identifier: NCT04165018
Recruitment Status : **RECRUITING NOW**
First Posted : November 15, 2019
Last Update Posted : February 13, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Othman, Baylor College of Medicine
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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.
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)
Actual Study Start Date :
April 9, 2021
Estimated Primary Completion Date :
September 2023
Estimated Study Completion Date :
December 2023
Resource links provided by the National Library of Medicine
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Intervention Details:
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Primary Outcome Measures :
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
Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle [ Time Frame: 2 years ]
Secondary Outcome Measures :
Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation [ Time Frame: 2 years ]
Biospecimen Retention: Â Samples Without DNAPancreatic mass biopsy for pathological evaluation
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
18 Years to 100 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Sampling Method: Â
Non-Probability Sample
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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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165018
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Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Mohamed O. Othman, MD   713-798-0950   Mohamed.Othman@bcm.edu  Â
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, United States, 77030
Contact: Mohamed O. Othman, MD   713-798-0950   Mohamed.Othman@bcm.edu  Â
Contact: Michael Mercado   7137983606   Michael.Mercado@bcm.edu  Â
Baylor College of Medicine
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Responsible Party:
Mohamed Othman, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT04165018 Â Â
Other Study ID Numbers:
H-44963
First Posted:
November 15, 2019 Â Â Key Record Dates
Last Update Posted:
February 13, 2023
Last Verified:
February 2023
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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 NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms
Endocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By 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.
