NCT01769248

Brief Summary

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved. The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

3 active sites

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

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 18, 2015

Completed
Last Updated

January 18, 2018

Status Verified

December 1, 2017

Enrollment Period

1.4 years

First QC Date

January 10, 2013

Results QC Date

March 5, 2015

Last Update Submit

December 19, 2017

Conditions

Pancreatic CancerLymphadenopathyGastrointestinal Stromal Tumor

Keywords

EUSFNAFNB

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Yield of EUS-FNB and EUS-FNA

    The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.

    1 year

Secondary Outcomes (2)

  • Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB

    1 year

  • Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)

    1 yr

Study Arms (2)

Fine needle aspiration

ACTIVE COMPARATOR

fine needle aspiration

Device: Fine needle aspirationDevice: Fine needle biopsy

Fine needle biopsy

ACTIVE COMPARATOR

Fine needle biopsy

Device: Fine needle aspirationDevice: Fine needle biopsy

Interventions

Fine needle aspirationDEVICE

Fine needle aspiration

Also known as: Echo Tip FNA Needle
Fine needle aspirationFine needle biopsy
Fine needle biopsyDEVICE

FNB

Also known as: Echo Tip Procore
Fine needle aspirationFine needle biopsy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent

You may not qualify if:

  • Coagulopathy which is not corrected
  • Diagnostic EUS determines lesion is not amenable to FNA or FNB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

California Pacific Medical Center

San Francisco, California, 94117, United States

Location

Moffit Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsLymphadenopathyGastrointestinal Stromal Tumors

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeGastrointestinal NeoplasmsGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Biopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesInvestigative Techniques

Results Point of Contact

Title
Srinadh Komanduri
Organization
Northwestern University
koman1973@gmail.com
312-695-0484

Study Officials

  • Srinadh Komanduri

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 16, 2013

Study Start

September 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 18, 2018

Results First Posted

March 18, 2015

Record last verified: 2017-12

Locations

US(3)