Cancer of Pancreas, Pancreatic Neoplasm
Conditions
Brief summary
This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.
Detailed description
The study compares the median number of passes to establish a definitive diagnosis using the 19G or 25G needles. Also, the ability of both needles to procure a histological core tissue is assessed.
Interventions
PROCEDUREPancreatic Biopsy
A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
PROCEDUREHistological Samples
The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
Sponsors
University of Alabama at Birmingham
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Patients with solid pancreatic mass lesions.
Exclusion criteria
1. Age \< 19 years 2. Unable to safely undergo EUS for any reason 3. Coagulopathy (INR \> 1.6, Prothrombin Time \> 18secs, Thrombocytopenia \< 80,000 cells/ml) 4. Unable to consent 5. Non-English speaking patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Number of Passes to Establish Diagnosis | 5 months | To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procurement of Histological Samples | 30 days | The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined. |
| Needle Dysfunction | 2 hours | The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient. |
| Complications | 30 days | The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 19G FNA Needle Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed. | 36 |
| 25G FNA Needle Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.
Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed. | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | 19G FNA Needle | Total | 25G FNA Needle |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 9.3 | 67.3 years STANDARD_DEVIATION 10.4 | 67.1 years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 18 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 28 Participants | 52 Participants | 24 Participants |
| Region of Enrollment United States | 36 participants | 72 participants | 36 participants |
| Sex: Female, Male Female | 15 Participants | 29 Participants | 14 Participants |
| Sex: Female, Male Male | 21 Participants | 43 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Median Number of Passes to Establish Diagnosis
To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.
Time frame: 5 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 19G FNA Needle | Median Number of Passes to Establish Diagnosis | 1 No. of passes |
| 25G FNA Needle | Median Number of Passes to Establish Diagnosis | 1 No. of passes |
Secondary
Complications
The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 19G FNA Needle | Complications | 2.8 percentage of participants |
| 25G FNA Needle | Complications | 0 percentage of participants |
Secondary
Needle Dysfunction
The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 19G FNA Needle | Needle Dysfunction | 0 percentage of participants |
| 25G FNA Needle | Needle Dysfunction | 2.8 percentage of participants |
Secondary
Procurement of Histological Samples
The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 19G FNA Needle | Procurement of Histological Samples | 86.1 percentage of participants |
| 25G FNA Needle | Procurement of Histological Samples | 33.3 percentage of participants |