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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 22G ProCore biopsy needle | Active Comparator | Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the standard FNA needle. |
|
| 22G standard FNA needle | Active Comparator | Using the 22G standard fine needle aspiration needle (FNA) for sampling pancreatic mass lesions, the tissue obtained will be compared to the 22 G ProCore needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 22G ProCore biopsy needle | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the Median Number of Passes Required to Establish a Diagnosis | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis Achieved With the Needle | 6 months | |
| Technical Failure | Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved |
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Inclusion Criteria:
-All patients with solid pancreatic mass lesions
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shyam Varadarajulu, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22658389 | Derived | Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 22G ProCore Biopsy | Acquire biopsy with procore needle Procore Biopsy: Acquire tissue with procore biopsy needle |
| FG001 | 22G FNA Needle | Acquire tissue with 22 gauge fine needle aspiration needle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ProCore Biopsy | Acquire biopsy with procore needle Procore Biopsy: Acquire tissue with procore biopsy needle |
| BG001 | FNA Needle | FNA: Acquire tissue with FNA needle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Compare the Median Number of Passes Required to Establish a Diagnosis | Posted | Median | Inter-Quartile Range | No. of passes for diagnosis | 6 months |
|
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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 | 22G ProCore Biopsy | Acquire biopsy with procore needle Procore Biopsy: Acquire tissue with procore biopsy needle |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | This patient was in the FNA group and was managed conservatively |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Shyam Varadarajulu | Center for Interventional Endoscopy, Florida Hospital | 407-303-2570 | svaradarajulu@yahoo.com |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| 22G standard FNA needle | Procedure | 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. |
|
|
| 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Diagnosis Achieved With the Needle | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Technical Failure | Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved | Posted | Number | participants | 6 months |
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| EG001 | 22G FNA Needle | Acquire tissue with 22 gauge fine needle aspiration needle | 0 | 28 | 1 | 28 |
|
| Mild acute pancreatitis | Gastrointestinal disorders | Non-systematic Assessment | This patient was managed conservatively |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |