NCT02424838

Brief Summary

After patients have been screened and have signed informed consent, they will be taken to the endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration (FNA), the subject will be randomized to 1 of 4 groups:

  • 22 gauge (G) needle with suction
  • 25 G needle with suction
  • 22 G needle without suction
  • 25 G needle without suction Follow-up Phone Call Phase: Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

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

July 28, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

February 11, 2015

Last Update Submit

February 12, 2019

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Proportion of diagnostic cell block specimens obtained according to needle size and the use of suction.

    The use of suction and a larger gauge needle during EUS-FNA is likely to increase the diagnostic yield of cell block. This may in turn translate to improved diagnosis and hence expedite patient management

    7 days (cell block processing in lab)

Secondary Outcomes (5)

  • Diagnostic adequacy of FNA cytology

    24 hours

  • Median number of passes to diagnosis

    24 hours

  • Specimen bloodiness

    24 hours

  • Rate of needle dysfunction

    24 hours

  • Rate of complications

    3 days

Study Arms (4)

22 gauge with suction

ACTIVE COMPARATOR

EUS-FNA of pancreatic masses will be performed with a 22 gauge needle using suction.

Procedure: EUS-FNA of pancreatic massesDevice: 22 gauge needle

22 gauge without suction

ACTIVE COMPARATOR

EUS-FNA of pancreatic masses will be performed with a 22 gauge needle without suction.

Procedure: EUS-FNA of pancreatic massesDevice: 22 gauge needle

25 gauge with suction

ACTIVE COMPARATOR

EUS-FNA of pancreatic masses will be performed with a 25 gauge needle using suction.

Procedure: EUS-FNA of pancreatic massesDevice: 25 gauge needle

25 gauge without suction

ACTIVE COMPARATOR

EUS-FNA of pancreatic masses will be performed with a 25 gauge needle without suction.

Procedure: EUS-FNA of pancreatic massesDevice: 25 gauge needle

Interventions

EUS-FNA of pancreatic massesPROCEDURE

EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.

22 gauge with suction22 gauge without suction25 gauge with suction25 gauge without suction
22 gauge needleDEVICE
22 gauge with suction22 gauge without suction
25 gauge needleDEVICE
25 gauge with suction25 gauge without suction

Eligibility Criteria

Age19 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA
  • Age ≥ 19 years

You may not qualify if:

  • Age \<19 years
  • Unable to safely undergo EUS for any reason
  • Coagulopathy (INR \>1.6, Thrombocytopenia with platelet count \<80,000/ml)
  • Unable to provide consent for any reason
  • Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital

Orlando, Florida, 32803, United States

Location

Related Publications (1)

  • Bang JY, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Endoscopic Ultrasound-guided Specimen Collection and Evaluation Techniques Affect Diagnostic Accuracy. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1820-1828.e4. doi: 10.1016/j.cgh.2018.03.004. Epub 2018 Mar 11.

    PMID: 29535060DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Shyam S Varadarajulu, MD

    AdventHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2015

First Posted

April 23, 2015

Study Start

July 28, 2014

Primary Completion

April 3, 2016

Study Completion

September 30, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

There is no plan to share Individual Participant Data.

Locations

US(1)