Evaluation of PCLs Using Three EUS-FNA Needles

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)

Time frame: At procedure (Up to 1 hour)

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.

Time frame: Procedure (Up to 1 hour)

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.

Time frame: Procedure (Up to 1 hour)

Total number of EUS-FNA needles used across all participants at the initial procedure.

Time frame: Procedure (Up to 1 hour)

Number of needles rated either Excellent or Very good when inserted into the echoendoscope at the initial procedure.

Time frame: Procedure (Up to 1 hour)

Population: Ease of needle passage into the echoendoscope is evaluated per needle.

Number of needles rated either Excellent or Very good when removed from the echoendoscope at the initial procedure.

Time frame: Procedure (Up to 1 hour)

Population: Ease of needle passage out of the echoendoscope is evaluated per needle.

Number of needles rated either Excellent or Very good for visualization at the initial procedure.

Time frame: Procedure (Up to 1 hour)

Population: Quality of needle visualization inside the cyst is evaluated per needle.

Post EUS-FNA patient management required (clinical and/or imaging surveillance, percutaneous drainage, surgical removal).

Time frame: 30 days

Population: 3 patients excluded from this analysis (1 patient in each Arm) due to missing data in post EUS-FNA patient management.

Patients whose Post EUS-FNA Management (clinical and/or imaging surveillance, percutaneous drainage, surgical removal) was Directly Influenced by the EUS-FNA findings.

Time frame: Procedure - 30 days after procedure

Population: 3 patients excluded from this analysis (1 patient in each Arm) due to missing data in patient management decision directly influenced by the EUS findings.

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.

Time frame: up to 2 years

Population: 3 patients excluded from analysis population in 19G Flex Arm due to histology diagnosis of neuroendocrine tumor (1), EUS diagnosis of neuroendocrine tumor (1), and solid cystic papillary neoplasm (1). 2 patients excluded from analysis population in 22G Arm due to missing EUS diagnosis (1) and EUS diagnosis of SPEN (1). 4 patients excluded from analysis population in 19G Arm due to missing EUS diagnosis (1) and EUS diagnosis of neuroendocrine tumor (3).

Patients whose pancreatic cyst lesion(s) can be reached and penetrated by the EUS-FNA needles.

Time frame: Procedure (Up to 1 hour)

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)

Time frame: Procedure (up to 1 hour)

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.

Time frame: 30 days

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.

Time frame: Procedure (Immediate)

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.

Time frame: Procedure (Up to 1 hour)

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.

Time frame: Procedure (Up to 1 hour)