Trial Outcomes & Findings for Comparison of a Novel 22-gauge Core Biopsy Needle (NCT NCT01598194)

Last Updated: 2018-12-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes.

Results posted on

2018-12-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Standard Suction Technique (SST) P30 participants randomized to SST (Standard Suction Technique)	Capillary Suction Technique (CST) 30 participants randomized to CST (Capillary Suction Technique
Overall Study STARTED	30	30
Overall Study 2 Passes With 25G for Cytology	30	30
Overall Study 1 Pass With 22Gpc for Cytology	29	30
Overall Study 1 Pass With 22Gpc for Histology	27	29
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of a Novel 22-gauge Core Biopsy Needle

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Suction Technique (SST) n=30 Participants 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	Capillary Suction Technique (CST) n=30 Participants 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 n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Age, Continuous	65 years n=5 Participants	61 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes.

Outcome measures

Outcome measures
Measure	Standard Suction Technique (SST) Cytology n=29 Participants 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.	Capillary Suction Technique (CST) n=30 Participants 30 participants randomized to CST (Capillary Suction Technique)
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. All pancreas masses: Score 0 or 1	5 Participants	6 Participants
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. All pancreas masses: Score 3	23 Participants	21 Participants
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. Adenocarcinoma: Score 0 or 1	4 Participants	5 Participants
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. Adenocarcinoma: Score 2 or 3	18 Participants	18 Participants
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. Adenocarcinoma: Score 3	17 Participants	17 Participants
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. All pancreas masses: Score 2 or 3	24 Participants	24 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard Suction Technique (SST) Cytology n=27 Participants 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.	Capillary Suction Technique (CST) n=29 Participants 30 participants randomized to CST (Capillary Suction Technique)
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. All pancreas masses: Score 0 or 1	8 Participants	9 Participants
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. All pancreas masses: Score 2 or 3	19 Participants	20 Participants
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. Adenocarcinoma: Score 0 or 1	5 Participants	8 Participants
Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. Adenocarcinoma: Score 2 or 3	15 Participants	14 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard Suction Technique (SST) Cytology n=59 Participants 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.	Capillary Suction Technique (CST) n=60 Participants 30 participants randomized to CST (Capillary Suction Technique)
Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis All pancreas masses: Score 2 or 3	48 Participants	57 Participants
Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis All pancreas masses: Score 3	44 Participants	45 Participants
Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis Adenocarcinoma: Score 2 or 3	36 Participants	43 Participants
Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis Adenocarcinoma: Score 3	34 Participants	34 Participants

Adverse Events

Standard Suction Technique (SST)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Capillary Suction Technique (CST)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Weston,Brian,MD / Gastroenterology Hepatology & Nutrition

UT MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place