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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: Completed study, sponsored by Baylor College of Medicine.

NCT04165018 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

% of core tissue obtained, number of needle passes made, and assessment of any procedure related adverse events

Interventions

  • PROCEDURE Fine-Needle Biopsy (FNB)

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2021-04-09
Est. Completion 2023-10-10
Baylor College of Medicine

616 total trials

What the finished NCT04165018 record still lists

NCT04165018 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Fine-Needle Biopsy (FNB) is the first listed.

NCT04165018 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT04165018, the US trial registry maintained by the National Library of Medicine. NCT04165018 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.