Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)
Mesenchymal Tumor, Autoimmune Pancreatitis, Lymphoma
About this trial
This is an interventional diagnostic trial for Mesenchymal Tumor focused on measuring SharkCore, ProCore
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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)
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
EUS-FNB with ProCore needle
EUS-FNB with SharkCore 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 completely removed, and negative suction pressure is applied using a 10 ml syringe for 30 seconds while the needle is stationary with the target. Then, the needle is moved back and forth several times within the target, utilizing the fanning technique. Finally, suction is released by closing the lock of the syringe and the needle is removed.
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.