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.
Brief Title
Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Gastroenterology
Lesions
Eligibility Criteria
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
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
Inclusion Criteria
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).
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).
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
18 Years
NCT Id
NCT02979509
Org Class
Other
Org Full Name
University of Florida
Org Study Id
IRB201600783
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling
Primary Outcomes
Outcome Measure
Overall diagnostic yield of EUS-TS
Outcome Time Frame
2 months
Secondary Outcomes
Outcome Time Frame
2 months
Outcome Measure
Diagnostic Yield of EUS-guided tissue sampling solid lesions
Outcome Time Frame
2 months
Outcome Measure
Diagnostic Yield of EUS-guided tissue sampling cystic lesions
Outcome Time Frame
2 months
Outcome Measure
Diagnostic yield of EUS-TS using through-the-needle micro forceps
Outcome Time Frame
2 months
Outcome Measure
Diagnostic yield of EUS-TS using fine-needle aspiration
Outcome Time Frame
2 months
Outcome Measure
Diagnostic yield of EUS-TS using core biopsy needle
Outcome Description
Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)
Outcome Time Frame
48 hours
Outcome Measure
Rate of adverse events associated with EUS-TS
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
The study will include all patients who are scheduled to undergo EUS-guided tissue sampling as part of their standard of care.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sammy Ho
Investigator Email
sho@montefiore.org
Investigator Phone