Clinical trial NCT02979509: Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling
Official title: Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenterology
Lesions
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Borland Groover Clinic, Jacksonville, FL
name: Northwestern University, Chicago, IL
name: Mayo Clinic
name: Montefiore Medical Center, Bronx, NY
name: Columbia University
name: Johns Hopkins University
name: New York University, New York, NY
name: Yale University
name: Geisinger Medical Center, Danville, PA
name: Ochsner Health System
First posted: 2016-12-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all patients who are scheduled to undergo EUS-guided tissue sampling as part of their standard of care.

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.

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

Primary outcomes:
measure: Overall diagnostic yield of EUS-TS
timeFrame: 2 months
Secondary outcomes:
measure: Diagnostic Yield of EUS-guided tissue sampling solid lesions
timeFrame: 2 months
measure: Diagnostic Yield of EUS-guided tissue sampling cystic lesions
timeFrame: 2 months
measure: Diagnostic yield of EUS-TS using through-the-needle micro forceps
timeFrame: 2 months
measure: Diagnostic yield of EUS-TS using fine-needle aspiration
timeFrame: 2 months
measure: Diagnostic yield of EUS-TS using core biopsy needle
timeFrame: 2 months
measure: Rate of adverse events associated with EUS-TS
timeFrame: 48 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Dennis Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang D, Trindade AJ, Yachimski P, Benias P, Nieto J, Manvar A, Ho S, Esnakula A, Gamboa A, Sethi A, Gupte A, Khara HS, Diehl DL, El Chafic A, Shah J, Forsmark CE, Draganov PV. Histologic Analysis of Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies Accurately Identifies Mucinous Pancreas Cysts. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1587-1596. doi: 10.1016/j.cgh.2018.11.027. Epub 2018 Nov 22.