Clinical trial · Interventional
22 G - 25 G SINS Trial for Pancreatic Masses
Randomized Trial Examining the Relationship Between Procedural Technique and Specimen Evaluation Methods in Patients Undergoing Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) of Pancreatic Masses
- 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)
After patients have been screened and have signed informed consent, they will be taken to the endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration (FNA), the subject will be randomized to 1 of 4 groups: * 22 gauge (G) needle with suction * 25 G needle with suction * 22 G needle without suction * 25 G needle without suction Follow-up Phone Call Phase: Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 22 gauge needle | Device | — | UNRESOLVED |
| 25 gauge needle | Device | — | UNRESOLVED |
| EUS-FNA of pancreatic masses | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- 22 gauge with suction
- description
- EUS-FNA of pancreatic masses will be performed with a 22 gauge needle using suction.
- interventionNames
- Procedure: EUS-FNA of pancreatic masses
- Device: 22 gauge needle
- type
- ACTIVE_COMPARATOR
- label
- 22 gauge without suction
- description
- EUS-FNA of pancreatic masses will be performed with a 22 gauge needle without suction.
- interventionNames
- Procedure: EUS-FNA of pancreatic masses
- Device: 22 gauge needle
- type
- ACTIVE_COMPARATOR
- label
- 25 gauge with suction
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 2. Age ≥ 19 years Exclusion Criteria: 1. Age \<19 years 2. Unable to safely undergo EUS for any reason 3. Coagulopathy (INR \>1.6, Thrombocytopenia with platelet count \<80,000/ml) 4. Unable to provide consent for any reason 5. Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)
References
Publications (1)
- DERIVEDBang JY, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Endoscopic Ultrasound-guided Specimen Collection and Evaluation Techniques Affect Diagnostic Accuracy. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1820-1828.e4. doi: 10.1016/j.cgh.2018.03.004. Epub 2018 Mar 11. PMID 29535060