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Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02979509
Collaborator
Borland Groover Clinic, Jacksonville, FL (Other), Northwestern University, Chicago, IL (Other), Mayo Clinic (Other), Montefiore Medical Center, Bronx, NY (Other), Columbia University (Other), Johns Hopkins University (Other), New York University, New York, NY (Other), Yale University (Other), Geisinger Medical Center, Danville, PA (Other), Ochsner Health System (Other)
54
Enrollment
1
Location
38.9
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
54 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Aug 30, 2019
Actual Study Completion Date :
Aug 30, 2019

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall diagnostic yield of EUS-TS [2 months]

    Secondary Outcome Measures

    1. Diagnostic Yield of EUS-guided tissue sampling solid lesions [2 months]

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

    3. Diagnostic yield of EUS-TS using through-the-needle micro forceps [2 months]

    4. Diagnostic yield of EUS-TS using fine-needle aspiration [2 months]

    5. Diagnostic yield of EUS-TS using core biopsy needle [2 months]

    6. Rate of adverse events associated with EUS-TS [48 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32608

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Dennis Yang, MD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT02979509
    Other Study ID Numbers:
    • IRB201600783
    First Posted:
    Dec 1, 2016
    Last Update Posted:
    Jan 6, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes

    Study Results

    No Results Posted as of Jan 6, 2020