Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)
Withdrawn before enrolling · Phase 2
Conditions studied: Mesenchymal Tumor, Autoimmune Pancreatitis, Lymphoma, Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT02766842
- Run by
- Johns Hopkins University
- People needed
- 0
- Starts
- 2016-04-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2017-05-15
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients ≥ 18 years of age referred for EUS
- Lesions requiring histologic diagnosis:
- Mesenchymal tumors
- Autoimmune pancreatitis
- Granulomatous disease
- Indeterminate hepatitis
- Confirmatory immunochemistry to establish a diagnosis (i.e. pancreatic neuroendocrine tumor)
- Lymphoma
- Solid tumors
- Previously non-diagnostic FNA
You may not qualify if…
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Uncooperative patients
- Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- Refusal to consent form
- Cystic lesions
- Inaccessible lesions to EUS (proximal to sigmoid colon or distal to second duodenum)
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.