Clinical trial · Observational
Prospective Study FNB, Is It Time To Abandon Cytological Assessment
Prospective Study FNB, Is It Time To Abandon Cytological Assessment (FACET)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fine-Needle Biopsy (FNB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Sensitivity and Specificity using FNB sampling pancreatic mass
- timeFrame
- 2 years
- description
- % of core tissue obtained, number of needle passes made, and assessment of any procedure related adverse events
- measure
- Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAyoub F, Khan V, Jain S, Raza R, Tan M, Zabad N, Keihanian T, Sparkman J, Jawaid S, Sealock RJ, Abidi W, Patel K, Othman MO. Diagnostic yield of endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions with tissue sent directly in formalin for histopathologic evaluation compared with cytology: a multicenter prospective pilot study. Gastrointest Endosc. 2026 Jul;104(1):107-110. doi: 10.1016/j.gie.2025.12.267. Epub 2025 Dec 16. PMID 41412424