Trial Outcomes & Findings for Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core) (NCT NCT01768325)

NCT ID: NCT01768325

Last Updated: 2017-03-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 85 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2017-03-29

Participant Flow

85 participants were enrolled in this study but only 78 were randomized.

Participant milestones

Measure	Quick Core Needle	ProCore Needle
Overall Study STARTED	37	41
Overall Study COMPLETED	37	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	QuickCore Needle n=37 Participants	ProCore Needle n=41 Participants	Total n=78 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	37 Participants n=5 Participants	41 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	41 participants n=7 Participants	78 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

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

Outcome measures

Measure	Quick Core Needle n=40 Participants 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.	ProCore Needle n=37 Participants Core biopsy needle comparison to obtain diagnostic yield. Cook Medical core biopsy needle: Obtaining a larger specimen.
Diagnostic Accuracy.	88 Percentage of participants	62 Percentage of participants

SECONDARY outcome

Timeframe: 36 months

Outcome measures

Measure	Quick Core Needle n=41 Participants 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.	ProCore Needle n=37 Participants Core biopsy needle comparison to obtain diagnostic yield. Cook Medical core biopsy needle: Obtaining a larger specimen.
Overall Specimen Length	19.4 mm Standard Deviation 14.1	4.3 mm Standard Deviation 4.5

SECONDARY outcome

Timeframe: 36 months

Outcome measures

Measure	Quick Core Needle n=41 Participants 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.	ProCore Needle n=37 Participants Core biopsy needle comparison to obtain diagnostic yield. Cook Medical core biopsy needle: Obtaining a larger specimen.
Number of Needle Passes	2.07 Needle passes Standard Deviation 0.72	2.14 Needle passes Standard Deviation 0.95

Adverse Events

Quick Core Needle

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ProCore Needle

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Quick Core Needle n=37 participants at risk	ProCore Needle n=41 participants at risk
Gastrointestinal disorders Abdominal pain	5.4% 2/37 • Number of events 2 • 3 years that patients were enrolled.	2.4% 1/41 • Number of events 1 • 3 years that patients were enrolled.
Gastrointestinal disorders Melena	2.7% 1/37 • Number of events 1 • 3 years that patients were enrolled.	0.00% 0/41 • 3 years that patients were enrolled.
Gastrointestinal disorders Retroperitoneal bleeding	0.00% 0/37 • 3 years that patients were enrolled.	2.4% 1/41 • Number of events 1 • 3 years that patients were enrolled.
Gastrointestinal disorders Nausa/Vomiting	0.00% 0/37 • 3 years that patients were enrolled.	2.4% 1/41 • Number of events 1 • 3 years that patients were enrolled.
General disorders Fever	2.7% 1/37 • Number of events 1 • 3 years that patients were enrolled.	2.4% 1/41 • Number of events 1 • 3 years that patients were enrolled.

Additional Information

John DeWitt, MD

Indiana University School of Medicine

Phone: 317-944-1113

Email: jodewitt@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place