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Trial record 4 of 238 for:    gastroenterology | Recruiting Studies | United States

Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling

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ClinicalTrials.gov Identifier: NCT02979509
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : November 30, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University of Florida

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
Gastroenterology Lesions 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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Ultrasound

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 Name: EUS-TS




Primary Outcome Measures :
  1. Overall diagnostic yield of EUS-TS [ Time Frame: 2 months ]

Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979509


Contacts
Contact: Dennis Yang, MD 352-273-8212 dennis.yang@medicine.ufl.edu
Contact: Peter V Draganov, MD 352-273-8212 peter.draganov@medicine.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Dennis Yang, MD    352-273-8212    dennis.yang@medicine.ufl.edu   
Contact: Peter V Draganov, MD    352-273-8212    peter.draganov@medicine.ufl.edu   
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02979509     History of Changes
Other Study ID Numbers: IRB201600783
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.