Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core)

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01768325
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.

This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Food and Drug Administration (FDA) for use.

Condition or Disease	Intervention/Treatment	Phase
GIST	Device: EUS-TCB needle (QuickCore) standard of care; Device: EUS-Guided biopsy needle (ProCore)	N/A

Detailed Description

Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G, ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G, Quick-Core, Cook Medical Inc., Winston-Salem, NC)

Secondary Objective To compare

• The number of needle passes requiring to acquire adequate specimen

• Length of core tissue obtained

• Diagnostic contribution of immunohistochemical staining

• Rates of complications

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EUS-Guided biopsy needle (ProCore) Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle. The number of needle passes requiring to acquire adequate specimen Length of core tissue obtained Diagnostic contribution of immunohistochemical staining Rates of complications	Device: EUS-Guided biopsy needle (ProCore); The number of needle passes requiring to acquire adequate specimen were tallied. Length of core tissue obtained Diagnostic contribution of immunohistochemical staining Rates of complications; Other Names: Comparison of core biopsy needles.
Active Comparator: EUS-TCB needle (Quick-Core) Comparison of core biopsy needles. The number of needle passes requiring to acquire adequate specimen Length of core tissue obtained Diagnostic contribution of immunohistochemical staining Rates of complications	Device: EUS-TCB needle (QuickCore) standard of care; The number of needle passes requiring to acquire adequate specimen were tallied. Length of core tissue obtained Diagnostic contribution of immunohistochemical staining Rates of complications; Other Names: Comparison of core biopsy needles.

Outcome Measures

Primary Outcome Measures

1. Diagnostic Accuracy. [36 months]

Secondary Outcome Measures

1. Overall Specimen Length [36 months]

2. Number of Needle Passes [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Solid tumors ≥ 2 cm in size.

Exclusion criteria:

• Thrombocytopenia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Hospital	Indianapolis	Indiana	United States	46202-5121

Sponsors and Collaborators

• Indiana University

Investigators

• Principal Investigator: John M. DeWitt, M.D., Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT01768325
• Other Study ID Numbers: 1104-03
• First Posted: Jan 15, 2013
• Last Update Posted: Mar 29, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Indiana University: ProCore Needle

Study Results

Participant Flow

Pre-assignment Detail	85 participants were enrolled in this study but only 78 were randomized.

Arm/Group Title	Quick Core Needle	ProCore Needle
Arm/Group Description
Period Title: Overall Study
STARTED	37	41
COMPLETED	37	41
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	QuickCore Needle	ProCore Needle	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	37	41	78
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	37 100%	41 100%	78 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	18 48.6%	17 41.5%	35 44.9%
Male	19 51.4%	24 58.5%	43 55.1%
Region of Enrollment (participants) [Number]
United States	37 100%	41 100%	78 100%

Outcome Measures

1. Secondary Outcome

Title	Overall Specimen Length
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Quick Core Needle	ProCore Needle
Arm/Group Description	Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle Cook Medical core biopsy needle: Obtaining a larger specimen.	Core biopsy needle comparison to obtain diagnostic yield. Cook Medical core biopsy needle: Obtaining a larger specimen.
Measure Participants	41	37
Mean (Standard Deviation) [mm]	19.4 (14.1)	4.3 (4.5)

2. Primary Outcome

Title	Diagnostic Accuracy.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

One patient was lost to follow up. Final diagnosis was unconfirmed.

Arm/Group Title	Quick Core Needle	ProCore Needle
Arm/Group Description
Measure Participants	40	37
Number [Percentage of participants]	88 237.8%	62 151.2%

3. Secondary Outcome

Title	Number of Needle Passes
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Quick Core Needle	ProCore Needle
Arm/Group Description
Measure Participants	41	37
Mean (Standard Deviation) [Needle passes]	2.07 (0.72)	2.14 (0.95)

Adverse Events

Time Frame	3 years that patients were enrolled.
Arm/Group Title	Quick Core Needle		ProCore Needle
Arm/Group Description
All Cause Mortality
	Quick Core Needle		ProCore Needle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Quick Core Needle		ProCore Needle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Quick Core Needle		ProCore Needle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/37 (8.1%)		3/41 (7.3%)
Gastrointestinal disorders
Abdominal pain	2/37 (5.4%)	2	1/41 (2.4%)	1
Melena	1/37 (2.7%)	1	0/41 (0%)	0
Retroperitoneal bleeding	0/37 (0%)	0	1/41 (2.4%)	1
Nausa/Vomiting	0/37 (0%)	0	1/41 (2.4%)	1
General disorders
Fever	1/37 (2.7%)	1	1/41 (2.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.