Health Condition 1: null- Pancreatic Cystic Lesions
Conditions
Interventions
Intervention1: 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.
Intervention2: 19 G Needle: Fine Needle Aspiratio
Sponsors
Boston Scientific
Eligibility
Inclusion 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
Exclusion criteria: Cysts in which FNA is not indicated based on review by the clinician, including potential concern of blood vessel location relative to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: At Procedure (Up to 1 hour) | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence, severity and relatedness of adverse events to the needle and procedure.Timepoint: 30 days;Time needed for aspiration for each pass and time from first needle pass in to last needle pass out.Timepoint: Procedure (Up to 1 hour);Ability to reach and penetrate the PCL, stratified by route of access and PCL location.Timepoint: Procedure (Up to 1 hour);Accuracy of two EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state categorized as one of the following: serous cyst, mucinous cyst, intra papillary mucinous neoplasm (IPMN), or pseudocyst.Timepoint: 30 days;Ease of needle passage in and out of echoendoscope and quality of needle visualization inside the cyst, categorized as Excellent, Very Good, Good, Fair, and PoorTimepoint: Procedure (Up to 1 hour);Extent of cyst aspiration as measured by reduction of maximal cyst diameter before and after FNA (converted to volume by standard geometric formulation).Timepoint: Procedure (Up to 1 hour);Impact of EUS-FNA based assays on diagnosis to determine type of cystTimepoint: Procedure - 30 days after procedure;Number of EUS-FNA needles and EUS-FNA needle passes used.Timepoint: Procedure (Up to 1 hour);Post EUS-FNA patient management plan (clinical and/or imaging surveillance, percutaneous aspiration, surgical removal).Timepoint: 30 days;Rate of cross-over to salvage armTimepoint: Procedure (Immediate);Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA)Timepoint: At procedure | — |
Countries
India, United States of America
Contacts
Public ContactSundeep Lakhtakia
Asian Institute of Gastroenterology
Outcome results
None listed