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OpenTrials
Completed

NCT Number: NCT02979509

Evaluation of Diagnostic Yield of EUS-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.

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Key information

Conditions

Gastroenterology Lesions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years old
  • Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions).
  • Target lesion should be ≥ 15 mm in size (long axis).

Exclusion criteria

  • Any contraindication to performing endoscopy
  • Unable to provide informed consent

Treatment and study plan

Endoscopic ultrasound- (EUS) guided tissue sampling

Other

EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.

Other names: EUS-TS

Primary outcomes

  1. Overall diagnostic yield of EUS-TS

    Time frame: 2 months

Secondary outcomes

  1. Diagnostic Yield of EUS-guided tissue sampling solid lesions

    Time frame: 2 months

  2. Diagnostic Yield of EUS-guided tissue sampling cystic lesions

    Time frame: 2 months

  3. Diagnostic yield of EUS-TS using through-the-needle micro forceps

    Time frame: 2 months

  4. Diagnostic yield of EUS-TS using fine-needle aspiration

    Time frame: 2 months

  5. Diagnostic yield of EUS-TS using core biopsy needle

    Time frame: 2 months

  6. Rate of adverse events associated with EUS-TS

    Time frame: 48 hours

    Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • 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
  • Northwestern University
  • Ochsner Health System
  • Yale University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 1, 2016
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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