Clinical trial NCT01711294: Evaluation of PCLs Using Three EUS-FNA Needles
Official title: A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cystic Lesions
Keywords: Pancreatic Cystic Lesions
PCL
EUS-FNA
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume
timeFrame: At procedure (Up to 1 hour)
Secondary outcomes:
measure: Number of Patients With Related Adverse Events
timeFrame: 30 days
measure: Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure
timeFrame: Procedure (Up to 1 hour)
measure: Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL
timeFrame: Procedure (up to 1 hour)
measure: Number of Participants With PCL Reached/Penetrated
timeFrame: Procedure (Up to 1 hour)
measure: Number of EUS-FNA Needle Passes at Initial Procedure.
timeFrame: Procedure (Up to 1 hour)
measure: Number of EUS-FNA Needles Used at Initial Procedure.
timeFrame: Procedure (Up to 1 hour)
measure: Time Needed for Aspiration for Each Needle Pass at Initial Procedure.
timeFrame: Procedure (Up to 1 hour)
measure: Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure.
timeFrame: Procedure (Up to 1 hour)
measure: Number of Needles With Needle Insertion Rated as Excellent/Very Good
timeFrame: Procedure (Up to 1 hour)
measure: Number of Needles With Needle Removal Rated as Excellent/Very Good
timeFrame: Procedure (Up to 1 hour)
measure: Number of Needles With Needle Visualization Rated as Excellent/Very Good
timeFrame: Procedure (Up to 1 hour)
measure: Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles
timeFrame: up to 2 years
measure: Number of Participants Requiring Post EUS-FNA Patient Management
timeFrame: 30 days
measure: Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings
timeFrame: Procedure - 30 days after procedure
measure: Rate of Cross-over to Salvage Arm
timeFrame: Procedure (Immediate)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia University Medical Center
state: New York
city: Shanghai
country: China
facility: Changhai Hospital
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
Study officials:
affiliation: Mayo Clinic
name: Michael B Wallace, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.