Clinical trial · Interventional
Evaluating the Number of Passes Required for Diagnostic Cell Block During EUS-FNA of Solid Pancreatic Mass Lesions
A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block During Endoscopic Ultrasound-Fine Needle Aspiration of Solid Pancreatic Mass Lesions
- 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)
This study will test the amount of tissue, called "cell block", obtained from your pancreas. Patients who are asked to participate in this study have a growth (mass) in the pancreas that needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number of times the doctor biopsies the mass), at this time we do not know the ideal number of passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this study is to compare the amount of tissue obtained with 2 passes versus 4 passes.
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 Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS FNA with 2 passes | Procedure | — | UNRESOLVED |
| EUS FNA with 4 passes | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EUS FNA with 2 passes
- description
- biopsy with 2 passes of the needle
- interventionNames
- Procedure: EUS FNA with 2 passes
- type
- ACTIVE_COMPARATOR
- label
- EUS FNA with 4 passes
- description
- biopsy with 4 passes of the needle
- interventionNames
- Procedure: EUS FNA with 4 passes
Primary outcomes (1)
- measure
- number of passes
- timeFrame
- up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: 1\) All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA. Exclusion Criteria: 1. Age \<19 years 2. Unable to safely undergo EUS for any reason 3. Coagulopathy (INR \>1.6, Prothrombin Time \>18secs, Thrombocytopenia \<80,000 cells/ml) 4. Unable to consent 5. Non-English speaking patients. 6. Participation in any other Clinical Trial (excluding registries and databases)
References
Publications (1)
- DERIVEDVaradarajulu S, Bang JY, Holt BA, Hasan MK, Logue A, Hawes RH, Hebert-Magee S. The 25-gauge EUS-FNA needle: Good for on-site but poor for off-site evaluation? Results of a randomized trial. Gastrointest Endosc. 2014 Dec;80(6):1056-63. doi: 10.1016/j.gie.2014.05.304. Epub 2014 Jun 25. PMID 24973173