N/A
N=250
Evaluation of PCLs Using Three EUS-FNA Needles
Pancreatic Cystic Lesions
Bottom Line
View on ClinicalTrials.gov: NCT01711294 ↗Enrolled (actual)
250
Serious AEs
2.0%
Results posted
Nov 2020
Primary outcome: Primary: Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume — 78; 74; 73 percentage of cyst volume aspirated — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 19 G Flex Needle (Device); 22 G Needle (Device); 19 G Needle (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume |
78; 74; 73 | 0.84 |
| SECONDARY Number of Patients With Related Adverse Events |
3; 2; 1 | — |
| SECONDARY Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure |
16; 13; 22 | — |
| SECONDARY Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL |
108; 53; 48 | — |
| SECONDARY Number of Participants With PCL Reached/Penetrated |
114; 62; 53 | — |
| SECONDARY Number of EUS-FNA Needle Passes at Initial Procedure. |
1; 1; 1 | — |
| SECONDARY Number of EUS-FNA Needles Used at Initial Procedure. |
156; 81; 78 | — |
| SECONDARY Time Needed for Aspiration for Each Needle Pass at Initial Procedure. |
86; 145; 106 | — |
| SECONDARY Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure. |
210; 198; 238 | — |
| SECONDARY Number of Needles With Needle Insertion Rated as Excellent/Very Good |
89; 65; 31 | — |
| SECONDARY Number of Needles With Needle Removal Rated as Excellent/Very Good |
108; 67; 47 | — |
| SECONDARY Number of Needles With Needle Visualization Rated as Excellent/Very Good |
98; 61; 50 | — |
| SECONDARY Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles |
91; 50; 50 | — |
| SECONDARY Number of Participants Requiring Post EUS-FNA Patient Management |
85; 45; 41 | — |
| SECONDARY Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings |
106; 56; 55 | — |
| SECONDARY Rate of Cross-over to Salvage Arm |
8; 8; 11 | — |
Summary
To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.
Eligibility Criteria
Inclusion Criteria
- Pancreatic cystic lesion measuring 13mm or greater in largest diameter.
- Indicated for EUS evaluation of the PCL including EUS-FNA.
- Age 18 years of age or older.
- Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.
Exclusion Criteria
- Cysts in which FNA is not indicated based on review by the clinician, including potential concern of blood vessel location relative to the cyst.
- Requirement for anticoagulation using clopidogril, warfarin, or other long acting antiplatelet agents (with the exception of aspirin) that cannot be safely stopped according to institutional guidelines.
- Standard contraindications for EUS.
- Known pancreatic pseudocyst.
- Pregnancy.
Data sourced from ClinicalTrials.gov (NCT01711294). 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.