Pancreatic Neoplasm
Conditions
Keywords
passes required to establish diagnosis
Brief summary
The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.
Detailed description
In this randomized trial, the 22G standard fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.
Interventions
PROCEDURE22G ProCore biopsy needle
Tissue will be acquired with the 22G Procore biopsy needle and the sample will be compared to the sample obtained with the 22G standard FNA needle.
PROCEDURE22G standard FNA needle
Tissue will be acquired with the 22G standard FNA biopsy needle and the sample will be compared to the sample obtained with the 22G ProCore biopsy needle.
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-All patients with solid pancreatic mass lesions
Exclusion criteria
* Coaguloapthy, * minors, * prgenant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the Median Number of Passes Required to Establish a Diagnosis | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis Achieved With the Needle | 6 months | — |
| Technical Failure | 6 months | Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ProCore Biopsy Acquire biopsy with procore needle
Procore Biopsy: Acquire tissue with procore biopsy needle | 28 |
| FNA Needle FNA: Acquire tissue with FNA needle | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | ProCore Biopsy | FNA Needle | Total |
|---|---|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 15.4 | 65.4 years STANDARD_DEVIATION 11.1 | 65.2 years STANDARD_DEVIATION 13.3 |
| Race/Ethnicity, Customized Black | 6 participants | 7 participants | 13 participants |
| Race/Ethnicity, Customized White | 22 participants | 21 participants | 43 participants |
| Region of Enrollment United States | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 28 | 1 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Compare the Median Number of Passes Required to Establish a Diagnosis
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 22G ProCore Biopsy | Compare the Median Number of Passes Required to Establish a Diagnosis | 1 No. of passes for diagnosis |
| 22G FNA Needle | Compare the Median Number of Passes Required to Establish a Diagnosis | 1 No. of passes for diagnosis |
Secondary
Diagnosis Achieved With the Needle
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 22G ProCore Biopsy | Diagnosis Achieved With the Needle | 25 participants |
| 22G FNA Needle | Diagnosis Achieved With the Needle | 28 participants |
Secondary
Technical Failure
Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 22G ProCore Biopsy | Technical Failure | 1 participants |
| 22G FNA Needle | Technical Failure | 0 participants |