Clinical trial NCT02154698: 22-gauge ProCore Needle v. Standard 22-gauge (P00030500)
Official title: A Multi-center Study Comparing Standard 22-gauge and 22-gauge ProCore Needles for Endobronchial Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quantity of Tissue Obtained
Quality of Tissue Obtained
Ease of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge Needles
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Cook Endoscopy
name: University of North Carolina
name: Johns Hopkins University
name: Thoraxklinik-Heidelberg gGmbH
First posted: 2014-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the usefulness of two needles (used for obtaining a lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial ultrasound

Detailed description: The purpose of this study is to compare the usefulness of two needles used for obtaining a lung tissue sample: (1) standard 22-gauge, and (2) ProCore 22-gauge. Both of these needles are used to get biopsies (samples) of lung tissue. The standard needle has one bevel (angled side of the needle formed when it is sharpened to make a point), while the ProCore needle has 2 bevels. The standard needle is more commonly used and we are doing this study to see if the ProCore needle would be more useful.

The investigator in charge of this study is Dr. Nichole T. Tanner. This study is being done at four sites and will involve approximately 200 volunteers.

Eligibility criteria: Inclusion Criteria:

1. Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node \>1 cm in short axis or a normal sized lymph node with uptake on FDG-PET scan that is higher than background PET activity.
2. Participants must be at least 18 years old or older, lack bleeding disorders, and be able to provide informed consent. The latter two criteria will be assessed from the patient's history and the consenting interview.

Exclusion Criteria:

1. Subjects who refuse to participate, or demonstrate inability to give informed consent
2. Subjects who are less than 18 years of age
3. Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
4. Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
5. Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).

Primary outcomes:
measure: Ease of use of 22-gauge ProCore EBUS needles and the standard 22-gauge needles.
timeFrame: Within two weeks from the day of the procedure
measure: Quality of tumor obtained (measured by cell block and ability to perform mutational analysis)
timeFrame: Within two weeks from the day of the procedure
measure: Quantity of tissue obtained (measured by number of unstructured fragments)
timeFrame: Within two weeks from the day of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Chapel Hill
country: United States
facility: University of North Carolina Medical School
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Nichole T Tanner, MD, M.S.C.R
role: PRINCIPAL_INVESTIGATOR
References: