Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling

NCT ID: NCT02979509

Last Updated: 2020-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-08-30

Brief Summary

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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

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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.

Conditions

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Gastroenterology Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Endoscopic ultrasound- (EUS) guided tissue sampling

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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EUS-TS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Borland Groover Clinic, Jacksonville, FL

UNKNOWN

Sponsor Role collaborator

Northwestern University, Chicago, IL

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Montefiore Medical Center, Bronx, NY

UNKNOWN

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

New York University, New York, NY

UNKNOWN

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Geisinger Medical Center, Danville, PA

UNKNOWN

Sponsor Role collaborator

Ochsner Health System

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Yang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30471456 (View on PubMed)

Other Identifiers

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IRB201600783

Identifier Type: -

Identifier Source: org_study_id

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