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2021-04-09
2023-04-06
2023-10-10
52
NCT04165018
Baylor College of Medicine
Baylor College of Medicine
OBSERVATIONAL
Prospective Study FNB, Is It Time To Abandon Cytological Assessment
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.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-11-01 | N/A | 2023-10-11 |
2019-11-13 | N/A | 2023-10-12 |
2019-11-15 | N/A | 2023-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle | 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation | 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
