NCT02979509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

3.2 years

First QC Date

November 29, 2016

Last Update Submit

January 2, 2020

Conditions

GastroenterologyLesions

Outcome Measures

Primary Outcomes (1)

  • Overall diagnostic yield of EUS-TS

    2 months

Secondary Outcomes (6)

  • Diagnostic Yield of EUS-guided tissue sampling solid lesions

    2 months

  • Diagnostic Yield of EUS-guided tissue sampling cystic lesions

    2 months

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

    2 months

  • Diagnostic yield of EUS-TS using fine-needle aspiration

    2 months

  • Diagnostic yield of EUS-TS using core biopsy needle

    2 months

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Endoscopic ultrasound- (EUS) guided tissue samplingOTHER

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

Also known as: EUS-TS
Endoscopic ultrasound- (EUS) guided tissue sampling

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

  • 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.

    PMID: 30471456DERIVED

Study Officials

  • Dennis Yang, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 1, 2016

Study Start

June 1, 2016

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)