Evaluation of PCLs Using Three EUS-FNA Needles
A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration
2 other identifiers
interventional
250
3 countries
8
Brief Summary
To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
8 active sites
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
First Submitted
Initial submission to the registry
September 26, 2012
CompletedFirst Posted
Study publicly available on registry
October 22, 2012
CompletedStudy Start
First participant enrolled
January 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2019
CompletedResults Posted
Study results publicly available
November 12, 2020
CompletedJanuary 15, 2021
January 1, 2021
4.4 years
September 26, 2012
October 20, 2020
January 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume
Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)
At procedure (Up to 1 hour)
Secondary Outcomes (15)
Number of Patients With Related Adverse Events
30 days
Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure
Procedure (Up to 1 hour)
Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL
Procedure (up to 1 hour)
Number of Participants With PCL Reached/Penetrated
Procedure (Up to 1 hour)
Number of EUS-FNA Needle Passes at Initial Procedure.
Procedure (Up to 1 hour)
- +10 more secondary outcomes
Study Arms (3)
19 G Flex Needle
ACTIVE COMPARATORDevice: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G Flex)
22 G Needle
ACTIVE COMPARATORDevice: Expect™ Endoscopic Ultrasound Aspiration Needle (22 G)
19 G Needle
ACTIVE COMPARATORDevice: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G)
Interventions
Fine Needle Aspiration of PCL with a 19 G Flex needle. If unsuccessful, a salvage procedure will be done with 19 G or 22 G needle.
Fine Needle Aspiration of PCL with a 22 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.
Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.
Eligibility Criteria
You may qualify if:
- Pancreatic cystic lesion measuring 13mm or greater in largest diameter.
- Indicated for EUS evaluation of the PCL including EUS-FNA.
- Age 18 years of age or older.
- Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.
You may not qualify if:
- Cysts in which FNA is not indicated based on review by the clinician, including potential concern of blood vessel location relative to the cyst.
- Requirement for anticoagulation using clopidogril, warfarin, or other long acting antiplatelet agents (with the exception of aspirin) that cannot be safely stopped according to institutional guidelines.
- Standard contraindications for EUS.
- Known pancreatic pseudocyst.
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032, United States
Changhai Hospital
Shanghai, 200433, China
Asian Institute of Gastroenterology
Hyderabad, 500 082, India
Related Publications (1)
Al-Haddad M, Wallace MB, Brugge W, Lakhtakia S, Li ZS, Sethi A, Pleskow D, Nguyen CC, Pannala R, DeWitt J, Raimondo M, Woodward TA, Ramchandani MJ, Jin Z, Xu C, Faigel DO. Fine-needle aspiration of pancreatic cystic lesions: a randomized study with long-term follow-up comparing standard and flexible needles. Endoscopy. 2021 Nov;53(11):1132-1140. doi: 10.1055/a-1311-9927. Epub 2021 Feb 4.
PMID: 33197941DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lina Ginnetti, Clinical Endoscopy Director
- Organization
- Boston Scientific Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B Wallace, MD,MPH
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2012
First Posted
October 22, 2012
Study Start
January 8, 2013
Primary Completion
June 6, 2017
Study Completion
December 18, 2019
Last Updated
January 15, 2021
Results First Posted
November 12, 2020
Record last verified: 2021-01