SharkCore Versus Acquire FNB

• Sponsor: Henning Gerke (Other)
• Overall Status: Completed
• CT.gov ID: NCT03672032
• Collaborator: (none)
• Enrollment: 134
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been established as an effective technique for sampling tissue inside and around the gastrointestinal tract, including the pancreas, liver, lymph nodes, and adrenal glands. EUS-FNA is convenient, minimally invasive, and safe procedure with an estimated sensitivity of 75%-92% and a specificity of 82%-100%.

Diagnosis of various pathologies in the GI tract including solid pancreatic masses, mediastinal or gastric lymph nodes, gastrointestinal submucosal lesions, and peri-rectal lesions require adequate tissue architecture and immunohistochemical analysis. This is difficult to obtain and is frequently insufficient with EUS-FNA cytology alone. The core tissue is required to improve the diagnostic yield and obtain histologic diagnosis along with immunostaining to establish specimen adequacy. In past 1 year two new needle EUS needle (Shark Core)and Acquire EUS needles has been introduced to improve diagnostic accuracy, tissue yield, and potentially obtain a core tissue sample. So far, no prospective studies have compared these two needles to see which one is better for overall diagnostic accuracy. Our goal is to perform a prospective analysis to compare the diagnostic yield and safety profile of these 2 new EUS needle.

Condition or Disease	Intervention/Treatment	Phase
EUS Guided Biopsy	Device: Fork-tip Needle; Device: Franseen Needle	N/A

Detailed Description

Subjects will come to a pre-procedure room on the day of the procedure. The investigator will again go over the risk and benefit of procedure and indication of the procedure. Once the consent form is signed, a large bore IV cannula is placed and the subject will be taken to the DHC procedure room. Once all the team members required to perform the procedure are in the room we will do a time-out to make sure current patient and procedure are performed. A time-out is done by asking the subject to tell his full name with date of birth and describe in his own words what procedure is planned for subject today. If all the things match the investigator will go ahead and start the sedation.

All EUS-FNB will be performed in the standard manner using linear echoendoscopes. All EUS-FNB procedures were performed by 1 of 2 highly experienced endosonographers (Henning Gerke or Rami EL-Abiad).

The needle to be used (SharkCore vs Acquire) will be decided based on randomization software. The needle will then be used to puncture the target lesion in standard fashion. Aspirated cellular materials will be expressed into the slide by advancing the stylet. The remainder will be expressed onto filter paper and submitted for cell block preparation. The subject's medical information including diagnosis, date of diagnosis, date of admission, blood test results, and medications received will be reviewed for analysis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Randomized Controlled Trial Comparing the Franseen Needle With a Fork-tip Needle for EUS-guided Fine Needle Biopsy
• Actual Study Start Date: Oct 29, 2018
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fork-tip Needle	Device: Fork-tip Needle; Fork-tip Needle will be used to obtain biopsy
Active Comparator: Franseen Needle	Device: Franseen Needle; Franseen Needle will be used to obtain biopsy

Outcome Measures

Primary Outcome Measures

1. Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained? [12 months]

   A pathologist blinded to clinical information will access each Biopsy specimen for adequacy (scoring system where scores of 0 were samples with no material, 1 - sufficient material for adequate histological interpretation, low quality (total material <10x power field in length), 2 - sufficient material for adequate histological interpretation, high quality (>10x power field in length)

Secondary Outcome Measures

1. Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Diagnostic Accuracy? [12 months]

   The diagnostic accuracy was calculated considering malignant diagnoses as a true positive. A histological or cytological diagnosis of a neoplastic lesion will be considered correct since false-positive diagnoses have been reported to be rare if strict cytological criteria are applied. The criterion standard for diagnosis of benign, non-neoplastic lesion that will not undergo surgical resection will be based on a combination of clinal impression, imaging characteristics and a clinical course that was consistent with the study diagnosis.

2. Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Number of Needle Passes Required to Obtain the Tissue Sample? [12 months]

   We will be collecting data on how many needle passes are required to get adequate FNB sample for each procedure. In the end, we will use this data to calculate using standard statistical measures to compare the average number of passes required to get adequate sample by both SharkCore and Acquire needle.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients schedule for EUS guided biopsy

Exclusion Criteria:

• Patients who had EUS-FNA for cystic fluid aspiration

• Pregnant females

• International normalized ratio >1.5 and platelet count < 50,000

• Medically unstable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52402

Sponsors and Collaborators

• Henning Gerke

Investigators

• Principal Investigator: Henning Gerke, MD, University of Iowa

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 12, 2018

More Information

Publications

None provided.

• Responsible Party: Henning Gerke, MD, Clinical Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT03672032
• Other Study ID Numbers: 201808820
• First Posted: Sep 14, 2018
• Last Update Posted: Jul 13, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

Participant Flow

Arm/Group Title	SharkCore Needle	Acquire Needle
Arm/Group Description	SharkCore Needle: SharkCore Needle will be used to obtain biopsy	Acquire Needle: Acquire Needle will be used to obtain biopsy
Period Title: Overall Study
STARTED	67	67
COMPLETED	67	67
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Fork-tip Needle	Franseen Needle	Total
Arm/Group Description	Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle: Franseen Needle will be used to obtain biopsy	Total of all reporting groups
Overall Participants	67	67	134
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	63.81 (12.49)	65.90 (12.34)	64 (11)
Sex: Female, Male (Count of Participants)
Female	34 50.7%	30 44.8%	64 47.8%
Male	33 49.3%	37 55.2%	70 52.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	67 100%	67 100%	134 100%

Outcome Measures

1. Primary Outcome

Title	Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained?
Description	A pathologist blinded to clinical information will access each Biopsy specimen for adequacy (scoring system where scores of 0 were samples with no material, 1 - sufficient material for adequate histological interpretation, low quality (total material <10x power field in length), 2 - sufficient material for adequate histological interpretation, high quality (>10x power field in length)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Histology Adequacy Score (0-2)

Arm/Group Title	Fork-tip Needle	Franseen Needle
Arm/Group Description	Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle: Fransee Needle will be used to obtain biopsy
Measure Participants	67	67
Measure Lesions	75	75
0, Insufficient	3	4
1, Sufficient, low quality	10	14
2, Sufficient, high quality	62	57

2. Secondary Outcome

Title	Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Diagnostic Accuracy?
Description	The diagnostic accuracy was calculated considering malignant diagnoses as a true positive. A histological or cytological diagnosis of a neoplastic lesion will be considered correct since false-positive diagnoses have been reported to be rare if strict cytological criteria are applied. The criterion standard for diagnosis of benign, non-neoplastic lesion that will not undergo surgical resection will be based on a combination of clinal impression, imaging characteristics and a clinical course that was consistent with the study diagnosis.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Combined diagnostic accuracy

Arm/Group Title	Fork-tip Needle	Franseen Needle
Arm/Group Description	Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle: Fransee Needle will be used to obtain biopsy
Measure Participants	67	67
Measure Lesions	75	75
Count of Units [Lesions]	69	65

3. Secondary Outcome

Title	Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Number of Needle Passes Required to Obtain the Tissue Sample?
Description	We will be collecting data on how many needle passes are required to get adequate FNB sample for each procedure. In the end, we will use this data to calculate using standard statistical measures to compare the average number of passes required to get adequate sample by both SharkCore and Acquire needle.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Needle passes

Arm/Group Title	Fork-tip Needle	Franseen Needle
Arm/Group Description	Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy	Franseen Needle: Fransee Needle will be used to obtain biopsy
Measure Participants	67	67
Measure Lesions	75	75
Median (Inter-Quartile Range) [number of needle passes]	3	3

Adverse Events

Time Frame	1 year
Arm/Group Title	Fork-tip Needle		Franseen Needle
Arm/Group Description	Fork-tip Needle: Fork-tip Needle will be used to obtain biopsy		Franseen Needle: Franseen Needle will be used to obtain biopsy
All Cause Mortality
	Fork-tip Needle		Franseen Needle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/67 (0%)
Serious Adverse Events
	Fork-tip Needle		Franseen Needle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		1/67 (1.5%)
Hepatobiliary disorders
Bleeding	0/67 (0%)	0	1/67 (1.5%)	1
Other (Not Including Serious) Adverse Events
	Fork-tip Needle		Franseen Needle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/67 (11.9%)		9/67 (13.4%)
Gastrointestinal disorders
Nausea/Vomiting	1/67 (1.5%)		1/67 (1.5%)
General disorders
Abdominal Pain	4/67 (6%)		5/67 (7.5%)
Hepatobiliary disorders
Pancreatitis	2/67 (3%)		3/67 (4.5%)
Cholangitis	1/67 (1.5%)		0/67 (0%)

Limitations/Caveats

[Not Specified]

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.