Clinical trialPhase 3Completed
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- January 2013
- Expected end
- January 2015
- Enrollment
- 121 participants
- Sites
- 2
- Primary outcomes
- Diagnostic Yield of Capillary Technique; Diagnostic Yield of Standard Technique; Sensitivity of EUS-FNA With Capillary Technique; Sensitivity of EUS-FNA With StandardTechnique; Sensitivity of EUS-FNA
- Sponsor
- Other
- Results posted
- 2017-04-13
- Last update
- 13 April 2017
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Diagnostic Yield of Capillary Technique [up to 6 months]. Number, percentage of specimen. Capillary Technique (n=61): 75.4.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Diagnostic Yield of Standard Technique [up to 6 months]. Number, percentage of specimen. Standard Technique (n=60): 65.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Sensitivity of EUS-FNA With Capillary Technique [6 months]. Number, participants. Positive EUS-FNA: Patients With Positive Gold Standard (n=48): 45; Patients With Negative Gold Standard (n=4): 0. Negative EUS-FNA: Patients With Positive Gold Standard (n=48): 3; Patients With Negative Gold Standard (n=4): 4. Analysis, Patients With Positive Gold Standard vs Patients With Negative Gold Standard: Sensitivity 93.7; other. Analysis, Patients With Positive Gold Standard vs Patients With Negative Gold Standard: Specificity 100; other.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Sensitivity of EUS-FNA With StandardTechnique [6 months]. Number, Participants. Positive EUS-FNA: Patients With Positive Gold Standard (n=44): 39. Negative EUS-FNA: Patients With Positive Gold Standard (n=44): 5. Analysis, Patients With Positive Gold Standard vs Patients With Negative Gold Standard: Sensitivity 88.6; other. Analysis, Patients With Positive Gold Standard vs Patients With Negative Gold Standard: Specificity 100; other.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Sensitivity of EUS-FNA [6 months]. Number, percentage of positive gold standard. Suction Technique (n=44): 88.6; Capillary Technique (n=52): 93.7. Analysis, Suction Technique vs Capillary Technique: p=0.47; Chi-squared; other.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
First Pass Diagnostic Rate [immediate]. Number, participants. Suction Technique (n=60): 23; Capillary Technique (n=61): 26. Analysis, Suction Technique vs Capillary Technique: p=0.71; Chi-squared; superiority or other.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Acquisition of Core Tissue [immediate]. Number, participants. Suction Technique (n=60): 28; Capillary Technique (n=61): 37. Analysis, Suction Technique vs Capillary Technique: p=0.15; Chi-squared; superiority or other.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Diagnostic Accuracy of EUS-FNA [6 months]. Number, percent accurate. Suction Technique (n=60): 88; Capillary Technique (n=61): 93.8. Analysis, Suction Technique vs Capillary Technique: p=0.46; Chi-squared; superiority or other.