Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroenterology; Lesions
• Intervention / Treatment: Other: Endoscopic ultrasound- (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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic ultrasound- (EUS) guided tissue sampling; All patients scheduled to undergo EUS with tissue sampling (TS) as medically indicated will be considered for the study. Patients in whom EUS-TS is considered as part of their standard medical care will be offered to participate in this study.	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.; Other Names: EUS-TS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall diagnostic yield of EUS-TS	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield of EUS-guided tissue sampling solid lesions		2 months
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-TS using fine-needle aspiration		2 months
Diagnostic yield of EUS-TS using core biopsy needle		2 months
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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Johns Hopkins University; Mayo Clinic; Yale University; Columbia University; Ochsner Health System; Borland Groover Clinic, Jacksonville, FL; Northwestern University, Chicago, IL; Montefiore Medical Center, Bronx, NY; New York University, New York, NY; Geisinger Medical Center, Danville, PA
• Investigators: Principal Investigator: Dennis Yang, MD, University of Florida

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB201600783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Computer-based files will only be made available to personnel involved in the study through the use of access privileges, passwords and encryption. The prospectively maintained database will be constructed with the Research Electronic Data Capture software.