Comparison of a Novel 22-gauge Core Biopsy Needle
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Novel 22-gauge Core Biopsy Needle Standard Biopsy Needle 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. |
Device: Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle
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.
|
Outcome Measures
Primary Outcome Measures
- Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. [Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes.]
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.
- Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. [Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes]
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.
Secondary Outcome Measures
- Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis [Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient age 18 years and older.
-
All patients referred for EUS FNA of endoscopically accessible solid pancreatic lesions.
Exclusion Criteria:
-
Unable to obtain informed consent.
-
Unable to tolerate the procedure.
-
Women with known pregnancy at time.
-
Patient age less than 18 years of age.
-
Bleeding diathesis
-
Cystic pancreatic lesions
-
Lesion not accessible by EUS guided FNA
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Brian Weston, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 2011-0907
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Standard Suction Technique (SST) | Capillary Suction Technique (CST) |
|---|---|---|
| Arm/Group Description | P30 participants randomized to SST (Standard Suction Technique) | 30 participants randomized to CST (Capillary Suction Technique |
| Period Title: Overall Study | ||
| STARTED | 30 | 30 |
| 2 Passes With 25G for Cytology | 30 | 30 |
| 1 Pass With 22Gpc for Cytology | 29 | 30 |
| 1 Pass With 22Gpc for Histology | 27 | 29 |
| COMPLETED | 30 | 30 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Standard Suction Technique (SST) | Capillary Suction Technique (CST) | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Total of all reporting groups |
| Overall Participants | 30 | 30 | 60 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
12
40%
|
19
63.3%
|
31
51.7%
|
| >=65 years |
18
60%
|
11
36.7%
|
29
48.3%
|
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
65
|
61
|
63
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
14
46.7%
|
11
36.7%
|
25
41.7%
|
| Male |
16
53.3%
|
19
63.3%
|
35
58.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
1
3.3%
|
1
1.7%
|
| Asian |
1
3.3%
|
0
0%
|
1
1.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
10%
|
5
16.7%
|
8
13.3%
|
| White |
26
86.7%
|
22
73.3%
|
48
80%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
2
6.7%
|
2
3.3%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
30
100%
|
30
100%
|
60
100%
|
Outcome Measures
| Title | Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. |
|---|---|
| Description | 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. |
| Time Frame | Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Suction Technique (SST) Cytology | Capillary Suction Technique (CST) |
|---|---|---|
| Arm/Group Description | 1 pass with 22Gpc for cytology, 1 pass with 22Gpc for histology using SST or CST. Diagnostic adequacy scores compared by technique for cytology and histology. | 30 participants randomized to CST (Capillary Suction Technique) |
| Measure Participants | 29 | 30 |
| All pancreas masses: Score 0 or 1 |
5
16.7%
|
6
20%
|
| All pancreas masses: Score 2 or 3 |
24
80%
|
24
80%
|
| All pancreas masses: Score 3 |
23
76.7%
|
21
70%
|
| Adenocarcinoma: Score 0 or 1 |
4
13.3%
|
5
16.7%
|
| Adenocarcinoma: Score 2 or 3 |
18
60%
|
18
60%
|
| Adenocarcinoma: Score 3 |
17
56.7%
|
17
56.7%
|
| Title | Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. |
|---|---|
| Description | 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. |
| Time Frame | Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Suction Technique (SST) Histology | Capillary Suction Technique (CST) Histology |
|---|---|---|
| Arm/Group Description | 1 pass with 22Gpc for histology using SST. Diagnostic adequacy scores compared by technique for histology. | 1 pass with 22Gpc for histology using CST. Diagnostic adequacy scores compared by technique for histology. |
| Measure Participants | 27 | 29 |
| All pancreas masses: Score 0 or 1 |
8
26.7%
|
9
30%
|
| All pancreas masses: Score 2 or 3 |
19
63.3%
|
20
66.7%
|
| Adenocarcinoma: Score 0 or 1 |
5
16.7%
|
8
26.7%
|
| Adenocarcinoma: Score 2 or 3 |
15
50%
|
14
46.7%
|
| Title | Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis |
|---|---|
| Description | 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. |
| Time Frame | Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 22G Procore Needle | Standard 25G Needle |
|---|---|---|
| Arm/Group Description | All patients: comparison of diagnostic adequacy of a single pass with a 22Gpc needle versus best of 2 passes with a standard 25G needle for cytological diagnosis. | All patients: comparison of diagnostic adequacy of a single pass with a 22Gpc needle versus best of 2 passes with a standard 25G needle for cytological diagnosis. |
| Measure Participants | 59 | 60 |
| All pancreas masses: Score 2 or 3 |
48
160%
|
57
190%
|
| All pancreas masses: Score 3 |
44
146.7%
|
45
150%
|
| Adenocarcinoma: Score 2 or 3 |
36
120%
|
43
143.3%
|
| Adenocarcinoma: Score 3 |
34
113.3%
|
34
113.3%
|
Adverse Events
| Time Frame | Electronic chart review was performed by the PI for any adverse events recorded within 2 weeks of the procedure | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Standard Suction Technique (SST) | Capillary Suction Technique (CST) | ||
| Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
| Standard Suction Technique (SST) | Capillary Suction Technique (CST) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | ||
Serious Adverse Events |
||||
| Standard Suction Technique (SST) | Capillary Suction Technique (CST) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Standard Suction Technique (SST) | Capillary Suction Technique (CST) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Weston,Brian,MD / Gastroenterology Hepatology & Nutrition |
|---|---|
| Organization | UT MD Anderson Cancer Center |
| Phone | 713-792-7734 |
| BWESTON@MDANDERSON.ORG |
- 2011-0907