Clinical trial · Interventional
Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms
Prospective Paired Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms
NCT01673334CI-TRIAL-00074261completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield than core biopsy.
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 Tumor | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fine Needle Aspiration (FNA) and Core biopsy (FNB) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fine Needle Aspiration and Core Biospsy
- description
- Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor.
- interventionNames
- Device: Fine Needle Aspiration (FNA) and Core biopsy (FNB)
Primary outcomes (1)
- measure
- Diagnostic Yield
- timeFrame
- One-week post procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than 18 and less than 90 years. * Presence of a solid (greater than 60%) mass lesion within the pancreas on cross-sectional imaging, without a preceding tissue diagnosis. * Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not correct with the administration of fresh frozen plasma. * The patient must read and speak english and has signed informed consent document. * The patient is scheduled for diagnostic endosonography by their referring provider or UVa gastroenterologist. Exclusion Criteria: * Age less than 18 or greater than 90 years. * The patient is unable to read or understand the consent form. * The patient is currently pregnant. * The patient has an uncorrectable coagulopathy as defined by a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) which does not improve with administration of fresh frozen plasma. * The patient has a pancreatic mass lesion which is predominantly cystic (greater than 40%). * No mass lesion is identified at the time of endosonography.
References
Publications (0)
Data not yet available
No reference posted for this study.