Gastroenterology, Lesions
Conditions
Brief summary
All patients will receive standard medical care and no experimental interventions will be performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles.
Detailed description
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles. More recently, a novel through-the-needle microforceps has been introduced. The MorayTM microforceps fits through a 19-gauge FNA needle and allows targeted tissue sampling under EUS visualization. Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.
Interventions
OTHEREndoscopic ultrasound- (EUS) guided tissue sampling
EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.
Sponsors
Borland Groover Clinic, Jacksonville, FL
Northwestern University, Chicago, IL
Mayo Clinic
Montefiore Medical Center, Bronx, NY
Columbia University
Johns Hopkins University
New York University, New York, NY
Yale University
Geisinger Medical Center, Danville, PA
Ochsner Health System
University of Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age \>18 years old 2. Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). 3. Target lesion should be ≥ 15 mm in size (long axis).
Exclusion criteria
1. Any contraindication to performing endoscopy 2. Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall diagnostic yield of EUS-TS | 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield of EUS-guided tissue sampling cystic lesions | 2 months | — |
| Diagnostic yield of EUS-TS using through-the-needle micro forceps | 2 months | — |
| Diagnostic Yield of EUS-guided tissue sampling solid lesions | 2 months | — |
| Diagnostic yield of EUS-TS using core biopsy needle | 2 months | — |
| Rate of adverse events associated with EUS-TS | 48 hours | Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE) |
| Diagnostic yield of EUS-TS using fine-needle aspiration | 2 months | — |
Countries
United States
Outcome results
None listed