Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
Randomized Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
1 other identifier
interventional
51
1 country
1
Brief Summary
This study will test two different needles for performing a biopsy of the pancreas during endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The purpose of this study is to compare which of the two needles is better for performing biopsies of the pancreas on masses that are greater than 35mm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pancreatic-cancer
Started Feb 2013
Shorter than P25 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 26, 2013
CompletedFirst Posted
Study publicly available on registry
March 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 3, 2017
August 1, 2017
10 months
February 26, 2013
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of passes
The use of a 19G FNA needle reduces the number of passes required to establish a diagnosis in pancreatic tumors that are greater than 35mm in size. This translates to less sedation, faster patient recovery, better safety and time efficiency.
Up to 12 months
Secondary Outcomes (1)
Rate of Complication
Up to 12 months
Study Arms (2)
19 Gauge needle biopsy
ACTIVE COMPARATORbiopsy with 19 gauge needle
25 gauge needle biopsy
ACTIVE COMPARATORbiopsy with 25 gauge needle
Interventions
biopsy with 19 gauge needle
biopsy with 25 gauge needle
Eligibility Criteria
You may qualify if:
- All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions greater than 35 mm on computed tomography (CT) that require FNA.
You may not qualify if:
- Age \< 19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR \>1.6, Prothrombin Time \>18secs, Thrombocytopenia \<80,000 cells/ml)
- Unable to consent
- Non-English speaking patients
- Participation in any other clinical trial (excluding registries or databases)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AdventHealthlead
Study Sites (1)
Florida Hospital
Orlando, Florida, 32803, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shyam Varadarajulu, MD
AdventHealth
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 26, 2013
First Posted
March 21, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
August 3, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share