Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling

Gastroenterology Clinical Trial

Official title:

Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979509
• Other study ID #: IRB201600783
• Status: Completed
• Start date: June 2016
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroenterology
• Lesions

Intervention

Other:
• Endoscopic 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (11)

Lead Sponsor	Collaborator
University of Florida	Borland Groover Clinic, Jacksonville, FL, Columbia University, Geisinger Medical Center, Danville, PA, Johns Hopkins University, Mayo Clinic, Montefiore Medical Center, Bronx, NY, New York University, New York, NY, Northwestern University, Chicago, IL, Ochsner Health System, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall diagnostic yield of EUS-TS		2 months
Secondary	Diagnostic Yield of EUS-guided tissue sampling solid lesions		2 months
Secondary	Diagnostic Yield of EUS-guided tissue sampling cystic lesions		2 months
Secondary	Diagnostic yield of EUS-TS using through-the-needle micro forceps		2 months
Secondary	Diagnostic yield of EUS-TS using fine-needle aspiration		2 months
Secondary	Diagnostic yield of EUS-TS using core biopsy needle		2 months
Secondary	Rate of adverse events associated with EUS-TS	Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)	48 hours