Autoimmune Pancreatitis, Lymphoma, Mesenchymal Tumor, Solid Tumors
Conditions
Keywords
SharkCore, ProCore
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEUS-FNB with ProCore needle
The use of the standard ProCore needle to acquire diagnostic tissue
PROCEDUREEUS-FNB with SharkCore needle
The use of new SharkCore needle to acquire diagnostic tissue
DEVICEProCore needle
This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance
DEVICESharkCore needle
This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method | Up to 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of passes to procure core tissue from needle | During procedure | The number of passes needed to acquire core tissue as assessed by the pathologist in the room. |
| Safety of tissue procurement by needle | Up to 1 year | All complications related to needle used will be recorded with a preset questionnaire to measure the frequency of complications related to needle used. |
| Procedure time | During procedure | 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. |
Countries
United States
Outcome results
None listed