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Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling

University of Florida logo

University of Florida

Status

Completed

Conditions

Gastroenterology
Lesions

Treatments

Other: Endoscopic ultrasound- (EUS) guided tissue sampling

Study type

Observational

Funder types

Other

Identifiers

NCT02979509
IRB201600783

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

54 participants in 1 patient group

Endoscopic ultrasound- (EUS) guided tissue sampling
Description:
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.
Treatment:
Other: Endoscopic ultrasound- (EUS) guided tissue sampling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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