Evaluation of PCLs Using Three EUS-FNA Needles

Study Overview
=================
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.

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

Conditions
-----------------
Pancreatic Cystic Lesions

Intervention / Treatment
-----------------
* Device: 19 G Flex Needle
* Device: 22 G Needle
* Device: 19 G Needle


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 19 G Flex Needle<br>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G Flex) | Device: 19 G Flex Needle<br>* 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.<br>|
| Active Comparator: 22 G Needle<br>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22 G) | Device: 22 G Needle<br>* Fine Needle Aspiration of PCL with a 22 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.<br>|
| Active Comparator: 19 G Needle<br>Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G) | Device: 19 G Needle<br>* Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Related Adverse Events | Adverse events related to study procedure or study device were tabulated. Adverse events were assessed from the index procedure up to 30 days post procedure. | 30 days | 
| Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure | Change value is calculated as cyst volume measured after initial procedure (up to 1 hour) minus volume measured at the beginning of the initial procedure. Volume is measured using the standard geometric formula 4/3 πr³ where r is half the long axis. The volume unit is cc. | Procedure (Up to 1 hour) | 
| Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL | Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration (final cyst maximal diameter of less than 5mm) or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA) (sample volume of 3 cc or more) | Procedure (up to 1 hour) | 
| Number of Participants With PCL Reached/Penetrated | Patients whose pancreatic cyst lesion(s) can be reached and penetrated by the EUS-FNA needles. | Procedure (Up to 1 hour) | 
| Number of EUS-FNA Needle Passes at Initial Procedure. | Needle pass defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. | Procedure (Up to 1 hour) | 
| Number of EUS-FNA Needles Used at Initial Procedure. | Total number of EUS-FNA needles used across all participants at the initial procedure. | Procedure (Up to 1 hour) | 
| Time Needed for Aspiration for Each Needle Pass at Initial Procedure. | Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of needle pass in is time of the first needle puncture into the cyst lumen. Needle pass out is time of removal of needle outside the cyst lumen, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst. | Procedure (Up to 1 hour) | 
| Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure. | Needle pass is defined as needle insertion through needle removal outside the cyst lumen, but not including needle repositioning within a single or multi-compartment cyst. Time of first needle pass in is time of the first needle puncture into the cyst lumen. Time of last needle pass out is time of removal of needle outside the cyst lumen at the end of the last fluid aspiration from a single or multi-loculated cyst, or after 10 seconds of failed attempt to aspirate fluid after the last needle re-repositioning in a single or multi-compartment cyst. | Procedure (Up to 1 hour) | 
| Number of Needles With Needle Insertion Rated as Excellent/Very Good | Number of needles rated either Excellent or Very good when inserted into the echoendoscope at the initial procedure. | Procedure (Up to 1 hour) | 
| Number of Needles With Needle Removal Rated as Excellent/Very Good | Number of needles rated either Excellent or Very good when removed from the echoendoscope at the initial procedure. | Procedure (Up to 1 hour) | 
| Number of Needles With Needle Visualization Rated as Excellent/Very Good | Number of needles rated either Excellent or Very good for visualization at the initial procedure. | Procedure (Up to 1 hour) | 
| Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles | In order to assess the accuracy of EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state, the Disease State per EUS-FNA measure was compared to a reference diagnosis. The reference diagnostic standard was diagnosis from a surgical specimen histology, the true gold standard for cases that evolved to surgical resection within the follow-up of the study. For cases that did not progress to surgery within the follow-up period, the reference diagnostic standard was a composite diagnosis by a consensus board. The consensus board consisted of 3 experts who were blinded to the type of needle used. The consensus board diagnoses of disease state were based on baseline medical history, EUS and cross sectional imaging of the cyst, and aspirate characteristics (i.e. aspirate color and viscosity). If the EUS-FNA diagnosis matches with the histopathology or consensus board diagnosis, then the participant will be counted as having accurate diagnosis. | up to 2 years | 
| Number of Participants Requiring Post EUS-FNA Patient Management | Post EUS-FNA patient management required (clinical and/or imaging surveillance, percutaneous drainage, surgical removal). | 30 days | 
| Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings | Patients whose Post EUS-FNA Management (clinical and/or imaging surveillance, percutaneous drainage, surgical removal) was Directly Influenced by the EUS-FNA findings. | Procedure - 30 days after procedure | 
| Rate of Cross-over to Salvage Arm | In the case of inability to access the pancreatic cystic lesion or to attain complete cyst aspiration, salvage aspiration procedure should be performed. Patients randomized to 19G Flex should undergo a salvage procedure with 22G or 19G needle (needle choice at discretion of physician); patients randomized to 22G or 19G should undergo salvage procedure with 19G Flex needle. | Procedure (Immediate) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Cystic Lesions, PCL, EUS-FNA