Clinical trial · Interventional
Yield Rate for Procurement the Histologic Core With Endoscopic Ultrasound-guided Fine Needle Biopsy With 20-gauge Ultrasound Biopsy Needles for Solid Pancreatic Masses: Pilot Study
NCT03017599CI-TRIAL-00033053completedN/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)
To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.
Conditions
Conditions (2)
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 |
| Solid Pancreatic and Peripancreatic Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 20-gauge ProCore FNB needle | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- EUS-FNB using 20-gauge procore needle
- interventionNames
- Device: 20-gauge ProCore FNB needle
Primary outcomes (2)
- measure
- Procurement of the histologic core
- timeFrame
- 7 days after the procedure
- description
- The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures
- measure
- Diagnostic accuracy
- timeFrame
- 7 days after the procedure
- description
- \[Standard diagnosis\] * In operated patients; based on the surgical resection specimen * In non-operated patients; based on the conclusions of the diagnostic work-up and confirmed by a compatible clinical disease course
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * patients who are at least 20 years of age * patients who require endoscopic ultrasound-guided fine needle aspiration cytology or biopsy because of pancreatic or peripancreatic solid mass. Exclusion Criteria: * Cystic pancreatic mass in imaging tests such as CT or MRI or US * haemodynamically unstable patients * severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 50,000 cells/cubic millimeter \[cmm3\]) * patients unable to quit anticoagulant/anti-platelet therapy * pregnancy
References
Publications (2)
- BACKGROUNDLee JH, Stewart J, Ross WA, Anandasabapathy S, Xiao L, Staerkel G. Blinded prospective comparison of the performance of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of the pancreas and peri-pancreatic lesions. Dig Dis Sci. 2009 Oct;54(10):2274-81. doi: 10.1007/s10620-009-0906-1. Epub 2009 Aug 11. PMID 19669880
- BACKGROUNDSiddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28. PMID 19640524