A Phase 3 interventional study of Standard technique EUS-FNA and Capillary suction technique for EUS FNA in Pancreatic Solid Lesions and Pancreatic Mass, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by Johns Hopkins University · Phase 3, Interventional, and Diagnostic
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.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Device: Standard technique EUS-FNA
These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
Device: Capillary suction technique for EUS FNA
Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
Diagnostic Yield of Capillary Technique
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Time frame: up to 6 months
Diagnostic Yield of Standard Technique
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Time frame: up to 6 months
Sensitivity of EUS-FNA With Capillary Technique
Sensitivity of the EUS-FNA with Capillary technique
Time frame: 6 months
Sensitivity of EUS-FNA With StandardTechnique
Sensitivity of the EUS-FNA with Capillary technique
Time frame: 6 months
Sensitivity of EUS-FNA
Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions
Time frame: 6 months
First Pass Diagnostic Rate
The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass
Time frame: immediate
Acquisition of Core Tissue
The rate of acquiring core tissue of the pancreatic mass through EUS-FNA
Time frame: immediate
Diagnostic Accuracy of EUS-FNA
The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease
Time frame: 6 months
Patients were enrolled between September 2013 and December 2014 in two tertiary academic centers
| Milestone | Suction Technique | Capillary Technique |
|---|---|---|
| Started | 60 | 61 |
| Completed | 60 | 61 |
| Not completed | 0 | 0 |
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
| percentage of specimen | Capillary Technique |
|---|---|
| Diagnostic Yield of Capillary Technique | 75.4 |
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
| percentage of specimen | Standard Technique |
|---|---|
| Diagnostic Yield of Standard Technique | 65 |
Sensitivity of the EUS-FNA with Capillary technique
| participants | Patients With Positive Gold Standard | Patients With Negative Gold Standard |
|---|---|---|
| Positive EUS-FNA | 45 | 0 |
| Negative EUS-FNA | 3 | 4 |
Sensitivity of the EUS-FNA with Capillary technique
| Participants | Patients With Positive Gold Standard | Patients With Negative Gold Standard |
|---|---|---|
| Positive EUS-FNA | 39 | — |
| Negative EUS-FNA | 5 | — |
Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions
| percentage of positive gold standard | Suction Technique | Capillary Technique |
|---|---|---|
| Sensitivity of EUS-FNA | 88.6 | 93.7 |
The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass
| participants | Suction Technique | Capillary Technique |
|---|---|---|
| First Pass Diagnostic Rate | 23 | 26 |
The rate of acquiring core tissue of the pancreatic mass through EUS-FNA
| participants | Suction Technique | Capillary Technique |
|---|---|---|
| Acquisition of Core Tissue | 28 | 37 |
The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease
| percent accurate | Suction Technique | Capillary Technique |
|---|---|---|
| Diagnostic Accuracy of EUS-FNA | 88 | 93.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Suction Technique | — | 0/60 (0%) | 0/60 (0%) |
| Capillary Technique | — | 0/61 (0%) | 0/61 (0%) |
| Age, Continuous(years) | Suction Technique | Capillary Technique | Total |
|---|---|---|---|
| Mean | 64.1 ± 13.8 | 64.2 ± 13.8 | 64.15 ± 13.8 |
| Sex: Female, Male(Participants) | Suction Technique | Capillary Technique | Total |
|---|---|---|---|
| Female | 28 | 23 | 51 |
| Male | 32 | 38 | 70 |
| Prior History(participants) | Suction Technique | Capillary Technique | Total |
|---|---|---|---|
| Chronic Pancreatitis | 3 | 2 | 5 |
| Chemotherapy | 3 | 1 | 4 |
| Radiation therapy | 3 | 3 | 6 |
| Prior non-diagnostic FNA(participants) | Suction Technique | Capillary Technique | Total |
|---|---|---|---|
| Number | 7 | 8 | 15 |
| Antiplatelet therapy(participants) | Suction Technique | Capillary Technique | Total |
|---|---|---|---|
| Number | 6 | 14 | 20 |
| Pancreatic mass Location(participants) | Suction Technique | Capillary Technique | Total |
|---|---|---|---|
| Uncinate/Head | 31 | 42 | 73 |
| Neck | 6 | 1 | 7 |
| Body | 14 | 13 | 27 |
| Tail | 9 | 5 | 14 |
| Pancreatic mass size(Centimeter) | Suction Technique | Capillary Technique | Total |
|---|---|---|---|
| Mean | 2.86 ± 1.23 | 3.2 ± 1.63 | 3.03 ± 1.43 |
| Echogeicity of the lesion(participants) | Suction Technique | Capillary Technique | Total |
|---|---|---|---|
| Hypoecho | 52 | 55 | 107 |
| Isoecho | 7 | 6 | 13 |
| Hyperecho | 1 | 0 | 1 |
4 further baseline measures are reported on the registry.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins University