Pancreatic Cancer, Lymphadenopathy, Gastrointestinal Stromal Tumor
Conditions
Keywords
EUS, FNA, FNB
Brief summary
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved. The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.
Detailed description
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved. We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.
Interventions
DEVICEFine needle aspiration
Fine needle aspiration
DEVICEFine needle biopsy
FNB
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
\- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent
Exclusion criteria
* 3.2.1 Coagulopathy which is not corrected 3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield of EUS-FNB and EUS-FNA | 1 year | The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB | 1 year | The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB |
| Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%) | 1 yr | As above. Crossover to FNA or FNB occurs after 3 passes without adequate material |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fine Needle Aspiration fine needle aspiration
Fine needle aspiration: Fine needle aspiration | 70 |
| Fine Needle Biopsy Fine needle biopsy
Fine needle biopsy: FNB | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Fine Needle Biopsy | Fine Needle Aspiration | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 20 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 50 Participants | 107 Participants |
| Age, Continuous | 64.1 years STANDARD_DEVIATION 14.4 | 63.7 years STANDARD_DEVIATION 14.4 | 63.8 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment United States | 70 participants | 70 participants | 140 participants |
| Sex: Female, Male Female | 30 Participants | 36 Participants | 66 Participants |
| Sex: Female, Male Male | 40 Participants | 34 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Diagnostic Yield of EUS-FNB and EUS-FNA
The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fine Needle Aspiration | Diagnostic Yield of EUS-FNB and EUS-FNA | 67.1 percentage of patients |
| Fine Needle Biopsy | Diagnostic Yield of EUS-FNB and EUS-FNA | 90 percentage of patients |
Secondary
Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)
As above. Crossover to FNA or FNB occurs after 3 passes without adequate material
Time frame: 1 yr
Population: Participants receiving alternative tissue acquisition method when initial three passes with either EUS-FNA or EUS-FNB failed to provide an adequate specimen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fine Needle Aspiration | Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%) | 96.4 percentage of participants |
| Fine Needle Biopsy | Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%) | 41.7 percentage of participants |
Secondary
Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB
The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB
Time frame: 1 year
Population: Patients with pancreatic and non-pancreatic lesions receiving EUS-FNA and EUS-FNB.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fine Needle Aspiration | Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB | 60.0 percentage of participants |
| Fine Needle Biopsy | Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB | 82.8 percentage of participants |