2016-04
2017-02
2017-02
0
NCT02766842
Johns Hopkins University
Johns Hopkins University
INTERVENTIONAL
Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)
Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.
Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for the diagnosis and evaluation of lesions of the pancreas, the upper gastrointestinal tract, as well as adjacent structures, including lymph nodes. Cytology specimens provided from FNA cannot fully characterize certain neoplasms such as lymphomas or mesenchymal tumors. Core biopsy specimens for histological examinations are needed to provide accurate diagnoses. ProCore needles (ProCore, Wilson-Cook Medical Inc. Winston-Salem, NC) were designed to obtain histological and cytological samples. Studies comparing ProCore needles with standard FNA needles showed no significant difference in diagnostic accuracy, histological core tissue procurement or mean number of passes. To overcome the above mentioned limitations (mainly suboptimal core tissue procurement rates), a new novel SharkCore needle (Beacon Endoscopic, Newton, MA, USA) has been designed and approved for clinical human use by the FDA. The objective of the study is to compare the new EUS guided histology biopsy needle SharkCore to the currently used EUS histology needle, ProCore, for the histological diagnosis and evaluation of lesions.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-05-06 | N/A | 2017-05-11 |
2016-05-06 | N/A | 2017-05-15 |
2016-05-10 | N/A | 2017-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: EUS-FNB with ProCore needle General anesthesia or conscious sedation will be started and an upper endoscopic ultrasound will be inserted into the participants mouth and advanced to the site of the lesion. The lesion will be punctured by the ProCore needle, then the stylet is complet | PROCEDURE: EUS-FNB with ProCore needle
DEVICE: ProCore needle
|
| ACTIVE_COMPARATOR: EUS-FNB with SharkCore needle The procedure will be done in the same manner with same endoscopic technique and method of tissue procurement. The only difference will be using the SharkCore needle to acquire tissue. | PROCEDURE: EUS-FNB with SharkCore needle
DEVICE: SharkCore needle
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method | The final diagnosis of tissue from needle will be compared to the final diagnosis reached either by surgical removal of mass or other method of biopsy | Up to 1 month |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of passes to procure core tissue from needle | The number of passes needed to acquire core tissue as assessed by the pathologist in the room. | During procedure |
| Safety of tissue procurement by needle | All complications related to needle used will be recorded with a preset questionnaire to measure the frequency of complications related to needle used. | Up to 1 year |
| Procedure time | Time required to acquire tissue using each needle will be recorded from time of needle insertion to time of core tissue procurement as per pathologist. | During procedure |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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