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The goal of this clinical research study is to compare the performance of a newly available needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles to see which needle gives better diagnostic information for pancreatic lesions.
An endoscopic ultrasound-guided needle biopsy or FNA is a special endoscopic procedure used to sample lesions within or next to the digestive tract, including the pancreas. The needle is used to collect material for diagnosis. A special lighted, flexible tube called an endoscope is inserted through the mouth, into the stomach and small intestine. The endoscope also has an ultrasound probe at its tip which can be used to see the pancreas, which is located behind the stomach. The doctor will then use the ultrasound to guide the needle biopsy or FNA.
In this procedure, an average of 4 needle passes (needle sticks) is needed to collect enough tissue for diagnosis. However, the number of passes can be higher or lower, depending on the individual lesion and success of the needle passes.
If participant agrees to take part in this study, 2 different needles (the standard straight hollow-core needle and the new EchoTip® Procore™ needle) will be used to sample the pancreas lesion. Two (2) passes will be performed with each needle type and compared. If additional passes are needed for diagnosis, they will not be included in this study. After the first set of needle passes, the doctor may decide that more passes are needed.
Final test results will be taken from the diagnostic results from each needle pass. The results from both types of the needle will be included in the participant's medical record.
This is an investigational study. All needles used in this study are FDA approved and commercially available. Comparing the needles is investigational.
Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel 22-gauge Core Biopsy Needle Standard Biopsy Needle | Experimental | The 22-gauge core biopsy needle with reverse bevel design (EchoTip® Procore™) will be compared prospectively to the standard straight hollow-core 22-gauge or 25-gauge FNA needle already used in our clinical practice for the diagnosis of solid pancreatic lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle | Device | Two passes performed with the standard 22-gauge or 25-gauge straight hollow core needle and two passes will be performed using the 22-gauge EchoTip® Procore™ needle. All passes will be taken from a single lesion and from the same endoscopic location. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. | The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST and CST. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25 G needle. Each participant underwent 4 study passes, 2 passes with a standard 25 G needle using SST, plus a random assignment to one of two groups for 2 passes with the 22Gpc (1 pass for cytologic and 1 pass for histologic analysis) using SST (group 1) or CST (group 2). Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation. | Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes. |
| Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. | The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST versus CST on EUS-FNA. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count > 500 cells) or 3 (estimated cell count > 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score < 2 was considered inadequate. Histologic diagnostic adequacy was graded as either an adequate (score 2 or 3) or inadequate specimen for diagnosis. | Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis | The cytologic diagnostic adequacy of 22Gpc was compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count > 500 cells) or 3 (estimated cell count > 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score < 2 was considered inadequate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Weston, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28596983 | Derived | Weston BR, Ross WA, Bhutani MS, Lee JH, Pande M, Sholl AB, Krishnamurthy S. Prospective randomized comparison of a 22G core needle using standard versus capillary suction for EUS-guided sampling of solid pancreatic masses. Endosc Int Open. 2017 Jun;5(6):E505-E512. doi: 10.1055/s-0043-105492. Epub 2017 Jun 7. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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60 consecutive participants referred for diagnostic EUS-FNA of suspected solid pancreatic mass on CT imaging, recruited from February 2012 to July 2013, underwent 2 passes with a standard 25G needle for cytologic analysis, and were randomized, 30 per group, to undergo 2 passes with 22Gpc (1 pass each for cytology and histology), using SST or CST.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Suction Technique (SST) | P30 participants randomized to SST (Standard Suction Technique) |
| FG001 | Capillary Suction Technique (CST) | 30 participants randomized to CST (Capillary Suction Technique |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Suction Technique (SST) | SST: 2 passes with 25G for cytology, 1 pass each with 22Gpc for cytology and histology. Diagnostic adequacy scores compared by technique and by needle |
| BG001 | Capillary Suction Technique (CST) |
| 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 | Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. | The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST and CST. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25 G needle. Each participant underwent 4 study passes, 2 passes with a standard 25 G needle using SST, plus a random assignment to one of two groups for 2 passes with the 22Gpc (1 pass for cytologic and 1 pass for histologic analysis) using SST (group 1) or CST (group 2). Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation. | Posted | Count of Participants | Participants | No | Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes. |
|
Electronic chart review was performed by the PI for any adverse events recorded within 2 weeks of the procedure
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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 | Standard Suction Technique (SST) | Participants who are referred for EUS-FNA and consented will have their examination performed using two different needles: with the standard 22-gauge or 25-gauge straight hollow core needle |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Weston,Brian,MD / Gastroenterology Hepatology & Nutrition | UT MD Anderson Cancer Center | 713-792-7734 | BWESTON@MDANDERSON.ORG |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2012 | Mar 12, 2018 | Prot_SAP_000.pdf |
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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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|
| Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes |
CST: 2 passes with 25G for cytology, 1 pass each with 22Gpc for cytology and histology. Diagnostic adequacy scores compared by technique and by needle
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | Capillary Suction Technique (CST) | 30 participants randomized to CST (Capillary Suction Technique) |
|
|
| Primary | Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. | The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST versus CST on EUS-FNA. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count > 500 cells) or 3 (estimated cell count > 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score < 2 was considered inadequate. Histologic diagnostic adequacy was graded as either an adequate (score 2 or 3) or inadequate specimen for diagnosis. | Posted | Count of Participants | Participants | No | Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes |
|
|
|
| Secondary | Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis | The cytologic diagnostic adequacy of 22Gpc was compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count > 500 cells) or 3 (estimated cell count > 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score < 2 was considered inadequate. | Posted | Count of Participants | Participants | No | Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Capillary Suction Technique (CST) | Participants who are referred for EUS-FNA and consented will have their examination performed using two different needles: with the standard 22-gauge or 25-gauge straight hollow core needle | 0 | 30 | 0 | 30 | 0 | 30 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Adenocarcinoma: Score 0 or 1 |
|
| Adenocarcinoma: Score 2 or 3 |
|
| Adenocarcinoma: Score 2 or 3 |
|
| Adenocarcinoma: Score 3 |
|