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NCT04165018 · ClinicalTrials.gov registry record
Prospective Study FNB, Is It Time To Abandon Cytological Assessment
A clinical trial, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- 52
- Enrollment target
NCT04165018 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 52 participants.
The verdict
NCT04165018 has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Fine-Needle Biopsy (FNB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-04-09 |
| Est. Completion | 2023-10-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04165018
The ClinicalTrials.gov registry entry for NCT04165018 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fine-Needle Biopsy (FNB) is the first listed.
NCT04165018 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04165018 about?
NCT04165018 is a clinical study titled "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 pancre...
What is the current status of trial NCT04165018?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2021-04-09. Estimated completion is 2023-10-10.
What interventions are being tested in trial NCT04165018?
The interventions under investigation include: Fine-Needle Biopsy (FNB) (PROCEDURE).
Who is sponsoring clinical trial NCT04165018?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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