Pancreatic Mass, Pancreatic Solid Lesions
Conditions
Keywords
Pancreatic solid lesions, Pancreatic mass, Pancreatic cancer, Endoscopic Ultrasound, EUS, Fine needle aspiration, FNA, EUS-FNA
Brief 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.
Interventions
DEVICEStandard technique 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.
DEVICECapillary suction technique for EUS FNA
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
Sponsors
Boston Scientific Corporation
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of EUS-FNA | 6 months | Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions |
| Diagnostic Yield of Standard Technique | up to 6 months | Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained. |
| Sensitivity of EUS-FNA With Capillary Technique | 6 months | Sensitivity of the EUS-FNA with Capillary technique |
| Sensitivity of EUS-FNA With StandardTechnique | 6 months | Sensitivity of the EUS-FNA with Capillary technique |
| Diagnostic Yield of Capillary Technique | up to 6 months | Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of Core Tissue | immediate | The rate of acquiring core tissue of the pancreatic mass through EUS-FNA |
| Diagnostic Accuracy of EUS-FNA | 6 months | The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease |
| First Pass Diagnostic Rate | immediate | The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled between September 2013 and December 2014 in two tertiary academic centers
Pre-assignment details
Patients were excluded from the study because a predominantly cystic lesion was found; the lack of an appreciable mass at EUS, unavailable on-site pathology and respiratory distress precluding completion of the examination
Participants by arm
| Arm | Count |
|---|---|
| Suction Technique 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.
Standard technique 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. | 60 |
| Capillary Technique 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.
Capillary suction technique for EUS FNA: 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 | 61 |
| Total | 121 |
Baseline characteristics
| Characteristic | Capillary Technique | Suction Technique | Total |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 13.8 | 64.1 years STANDARD_DEVIATION 13.8 | 64.15 years STANDARD_DEVIATION 13.8 |
| Antiplatelet therapy | 14 participants | 6 participants | 20 participants |
| Biliary stent present Metal stent | 5 participants | 1 participants | 6 participants |
| Biliary stent present Plastic stent | 6 participants | 7 participants | 13 participants |
| Cystic Component | 10 mass | 12 mass | 22 mass |
| Echogeicity of the lesion Hyperecho | 0 participants | 1 participants | 1 participants |
| Echogeicity of the lesion Hypoecho | 55 participants | 52 participants | 107 participants |
| Echogeicity of the lesion Isoecho | 6 participants | 7 participants | 13 participants |
| EUS features of chronic pancreatitis | 7 participants | 11 participants | 18 participants |
| Pancreatic mass Location Body | 13 participants | 14 participants | 27 participants |
| Pancreatic mass Location Neck | 1 participants | 6 participants | 7 participants |
| Pancreatic mass Location Tail | 5 participants | 9 participants | 14 participants |
| Pancreatic mass Location Uncinate/Head | 42 participants | 31 participants | 73 participants |
| Pancreatic mass size | 3.2 Centimeter STANDARD_DEVIATION 1.63 | 2.86 Centimeter STANDARD_DEVIATION 1.23 | 3.03 Centimeter STANDARD_DEVIATION 1.43 |
| Prior History Chemotherapy | 1 participants | 3 participants | 4 participants |
| Prior History Chronic Pancreatitis | 2 participants | 3 participants | 5 participants |
| Prior History Radiation therapy | 3 participants | 3 participants | 6 participants |
| Prior non-diagnostic FNA | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 23 Participants | 28 Participants | 51 Participants |
| Sex: Female, Male Male | 38 Participants | 32 Participants | 70 Participants |
| Vascular involvement Arterial | 21 mass | 28 mass | 49 mass |
| Vascular involvement Arterial and Venous | 14 mass | 19 mass | 33 mass |
| Vascular involvement Venous | 32 mass | 28 mass | 60 mass |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 61 |
| serious Total, serious adverse events | 0 / 60 | 0 / 61 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capillary Technique | Diagnostic Yield of Capillary Technique | 75.4 percentage of specimen |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capillary Technique | Diagnostic Yield of Standard Technique | 65 percentage of specimen |
Primary
Sensitivity of EUS-FNA
Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions
Time frame: 6 months
Population: The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capillary Technique | Sensitivity of EUS-FNA | 88.6 percentage of positive gold standard |
| Patients With Negative Gold Standard | Sensitivity of EUS-FNA | 93.7 percentage of positive gold standard |
p-value: 0.47Chi-squared
Primary
Sensitivity of EUS-FNA With Capillary Technique
Sensitivity of the EUS-FNA with Capillary technique
Time frame: 6 months
Population: The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capillary Technique | Sensitivity of EUS-FNA With Capillary Technique | Positive EUS-FNA | 45 participants |
| Capillary Technique | Sensitivity of EUS-FNA With Capillary Technique | Negative EUS-FNA | 3 participants |
| Patients With Negative Gold Standard | Sensitivity of EUS-FNA With Capillary Technique | Positive EUS-FNA | 0 participants |
| Patients With Negative Gold Standard | Sensitivity of EUS-FNA With Capillary Technique | Negative EUS-FNA | 4 participants |
Primary
Sensitivity of EUS-FNA With StandardTechnique
Sensitivity of the EUS-FNA with Capillary technique
Time frame: 6 months
Population: The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capillary Technique | Sensitivity of EUS-FNA With StandardTechnique | Positive EUS-FNA | 39 Participants |
| Capillary Technique | Sensitivity of EUS-FNA With StandardTechnique | Negative EUS-FNA | 5 Participants |
Secondary
Acquisition of Core Tissue
The rate of acquiring core tissue of the pancreatic mass through EUS-FNA
Time frame: immediate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capillary Technique | Acquisition of Core Tissue | 28 participants |
| Patients With Negative Gold Standard | Acquisition of Core Tissue | 37 participants |
p-value: 0.15Chi-squared
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capillary Technique | Diagnostic Accuracy of EUS-FNA | 88 percent accurate |
| Patients With Negative Gold Standard | Diagnostic Accuracy of EUS-FNA | 93.8 percent accurate |
p-value: 0.46Chi-squared
Secondary
First Pass Diagnostic Rate
The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass
Time frame: immediate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capillary Technique | First Pass Diagnostic Rate | 23 participants |
| Patients With Negative Gold Standard | First Pass Diagnostic Rate | 26 participants |
p-value: 0.71Chi-squared