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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fine needle aspiration | Active Comparator | fine needle aspiration |
|
| Fine needle biopsy | Active Comparator | Fine needle biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fine needle aspiration | Device | Fine needle aspiration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent
Exclusion Criteria:
3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB
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| Name | Affiliation | Role |
|---|---|---|
| Srinadh Komanduri | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| California Pacific Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fine Needle Aspiration (FNA) | fine needle aspiration Fine needle aspiration: Fine needle aspiration using endoscopic ultrasound-FNA needles. This was the standard of care arm |
| FG001 | Fine Needle Biopsy (FNB) | Fine Needle biopsy Fine Needle biopsy: FNB, test arm for core biopsies, endoscopic ultrasound-FNB |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fine Needle Aspiration | fine needle aspiration Fine needle aspiration: Fine needle aspiration |
| BG001 | Fine Needle Biopsy | Fine needle biopsy Fine needle biopsy: FNB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of patients | 1 year |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fine Needle Aspiration | Fine needle aspiration: Fine needle aspiration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Srinadh Komanduri | Northwestern University | 312-695-0484 | koman1973@gmail.com |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000072281 | Lymphadenopathy |
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
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| Fine needle biopsy | Device | FNB |
|
|
| 1 year |
| 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 | 1 yr |
| San Francisco |
| California |
| 94117 |
| United States |
| Moffit Cancer Center | Tampa | Florida | 33612 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| 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 | Patients with pancreatic and non-pancreatic lesions receiving EUS-FNA and EUS-FNB. | Posted | Number | percentage of participants | 1 year |
|
|
|
| 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 | Participants receiving alternative tissue acquisition method when initial three passes with either EUS-FNA or EUS-FNB failed to provide an adequate specimen. | Posted | Number | percentage of participants | 1 yr |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Fine Needle Biopsy | Fine needle biopsy Fine needle biopsy: FNB | 0 | 70 | 0 | 70 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |