Phase 3
Completed N=121
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions
Pancreatic Solid Lesions · Pancreatic Mass
Source: ClinicalTrials.gov NCT01936467 ↗
Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Diagnostic Yield of Capillary Technique — 75.4 percentage of specimen
◆ Published Evidence
Established
63citations · ~8 / year
Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial.
Summary
The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure.
There are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.
Linked Publications
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Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Yield of Capillary Technique |
75.4 | — |
| PRIMARY Diagnostic Yield of Standard Technique |
65 | — |
| PRIMARY Sensitivity of EUS-FNA With Capillary Technique |
45; 0; 3; 4 | — |
| PRIMARY Sensitivity of EUS-FNA With StandardTechnique |
39; 5 | — |
| PRIMARY Sensitivity of EUS-FNA |
88.6; 93.7 | 0.47 |
| SECONDARY First Pass Diagnostic Rate |
23; 26 | 0.71 |
| SECONDARY Acquisition of Core Tissue |
28; 37 | 0.15 |
| SECONDARY Diagnostic Accuracy of EUS-FNA |
88; 93.8 | 0.46 |
Eligibility Criteria
Inclusion Criteria
- In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA
Exclusion Criteria
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Uncooperative patients
- Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- Refusal to consent form
- Cystic lesions
- Inaccessible lesions to EUS
Data sourced from ClinicalTrials.gov (NCT01936467) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.