Clinical trial · Interventional
Fine Needle Biopsy of Solid Pancreatic Mass Lesions
Randomized Trial Comparing Fine Needle Biopsy Needles and Different Techniques for Endoscopic-guided Fine Needle Biopsy of Solid Pancreatic Mass Lesions
NCT04085055CI-TRIAL-00046448unknownN/AClinicalTrials.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)
This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.
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 |
|---|---|---|---|
| Solid pancreatic mass lesion biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- 22 Gauge FNB Needle - ProCore
- description
- The 22 Gauge FNB Needle - ProCore will be used to biopsy solid pancreatic mass lesions.
- interventionNames
- Diagnostic Test: Solid pancreatic mass lesion biopsy
- type
- ACTIVE_COMPARATOR
- label
- 22 Gauge FNB Needle - Acquire
- description
- The 22 Gauge FNB Needle - Acquire will be used to biopsy solid pancreatic mass lesions.
- interventionNames
- Diagnostic Test: Solid pancreatic mass lesion biopsy
- type
- ACTIVE_COMPARATOR
- label
- 22 Gauge FNB Needle - SharkCore
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging 2. Able and willing to provide written or verbal consent 3. ≥ 18 years old 4. Able to undergo conscious sedation for EUS procedure Exclusion Criteria: 1. \<18 years old 2. Unable to obtain informed consent from the patient 3. Medically unfit for sedation 4. Pregnant patients 5. No pancreatic mass lesions visualized on EUS 6. Irreversible coagulopathy as determined by platelet count \< 50,000/microL or International Normalized Ratio (INR) \> 1.5 7. Unable to stop anti-platelet agents prior to the procedure
References
Publications (12)
- BACKGROUNDNgamruengphong S, Li F, Zhou Y, Chak A, Cooper GS, Das A. EUS and survival in patients with pancreatic cancer: a population-based study. Gastrointest Endosc. 2010 Jul;72(1):78-83, 83.e1-2. doi: 10.1016/j.gie.2010.01.072. PMID 20620274
- BACKGROUNDOthman MO, Wallace MB. The role of endoscopic ultrasonography in the diagnosis and management of pancreatic cancer. Gastroenterol Clin North Am. 2012 Mar;41(1):179-88. doi: 10.1016/j.gtc.2011.12.014. Epub 2012 Jan 16. PMID 22341257
- BACKGROUNDHewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049. PMID 22248600
- BACKGROUNDVaradarajulu S, Fraig M, Schmulewitz N, Roberts S, Wildi S, Hawes RH, Hoffman BJ, Wallace MB. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy. 2004 May;36(5):397-401. doi: 10.1055/s-2004-814316. PMID 15100946
- BACKGROUNDBang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy. 2016 Apr;48(4):339-49. doi: 10.1055/s-0034-1393354. Epub 2015 Nov 12. PMID 26561917
- BACKGROUNDBang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. EUS-guided fine needle biopsy of pancreatic masses can yield true histology. Gut. 2018 Dec;67(12):2081-2084. doi: 10.1136/gutjnl-2017-315154. Epub 2017 Oct 7. No abstract available. PMID 28988195
- BACKGROUNDBang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6):1432-1438. doi: 10.1016/j.gie.2017.11.036. Epub 2018 Jan 3.