Clinical trial · Interventional
Comparison of a Novel 22-gauge Core Biopsy Needle
Prospective Comparison of a Novel 22-gauge Core Biopsy Needle With Reverse Bevel Design to a Standard Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) Needle for Diagnosis of Solid Pancreatic Mass Lesions
NCT01598194CI-TRIAL-00036279completedN/AResults postedClinicalTrials.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)
The goal of this clinical research study is to compare the performance of a newly available needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles to see which needle gives better diagnostic information for pancreatic 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 |
|---|---|---|---|
| Malignant Neoplasm of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
| Solid Pancreatic Mass Lesions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Novel 22-gauge Core Biopsy Needle Standard Biopsy Needle
- description
- The 22-gauge core biopsy needle with reverse bevel design (EchoTip® Procore™) will be compared prospectively to the standard straight hollow-core 22-gauge or 25-gauge FNA needle already used in our clinical practice for the diagnosis of solid pancreatic lesions.
- interventionNames
- Device: Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle
Primary outcomes (2)
- measure
- Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle.
- timeFrame
- Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes.
- description
- The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST and CST. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25 G needle. Each participant underwent 4 study passes, 2 passes with a standard 25 G needle using SST, plus a random assignment to one of two groups for 2 passes with the 22Gpc (1 pass for cytologic and 1 pass for histologic analysis) using SST (group 1) or CST (group 2). Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient age 18 years and older. 2. All patients referred for EUS FNA of endoscopically accessible solid pancreatic lesions. Exclusion Criteria: 1. Unable to obtain informed consent. 2. Unable to tolerate the procedure. 3. Women with known pregnancy at time. 4. Patient age less than 18 years of age. 5. Bleeding diathesis 6. Cystic pancreatic lesions 7. Lesion not accessible by EUS guided FNA
References
Publications (1)
- DERIVEDWeston BR, Ross WA, Bhutani MS, Lee JH, Pande M, Sholl AB, Krishnamurthy S. Prospective randomized comparison of a 22G core needle using standard versus capillary suction for EUS-guided sampling of solid pancreatic masses. Endosc Int Open. 2017 Jun;5(6):E505-E512. doi: 10.1055/s-0043-105492. Epub 2017 Jun 7. PMID 28596983