A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration
Status: Completed
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Mayo Clinic
Scottsdale
Florida
Mayo Clinic
Jacksonville
Indiana
Indiana University Medical Center
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Massachusetts General Hospital
Boston
New York
New York Presbyterian Hospital/Columbia University Medical Center
New York
Other Locations
China
Changhai Hospital
Shanghai
India
Asian Institute of Gastroenterology
Hyderabad
Time Frame
Start Date: 2013-01-08
Completion Date: 2019-12-18
Participants
Target number of participants: 250
Treatments
Active_comparator: 19 G Flex Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G Flex)
Active_comparator: 22 G Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22 G)
Active_comparator: 19 G Needle
Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G)
Authors
Sandeep Lakhtakia, Douglas Faigel, Michael B Wallace, Amrita Sethi, William Brugge, Douglas Pleskow, Zhao Shen Li, Sundeep Lakhtakia
Sponsors
Leads: Boston Scientific Corporation