Evaluation of PCLs Using Three EUS-FNA Needles

Boston Scientific

Status: Completed

Conditions: Pancreatic Cystic Lesions

Treatments: Device: 22 G Needle; Device: 19 G Needle; Device: 19 G Flex Needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01711294

E7084 (Other Identifier)

90869947

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 3 patient groups

19 G Flex Needle

Active Comparator group

Description:

Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G Flex)

Treatment:

Device: 19 G Flex Needle

22 G Needle

Active Comparator group

Description:

Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22 G)

Treatment:

Device: 22 G Needle

19 G Needle

Active Comparator group

Description:

Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19 G)

Treatment:

Device: 19 G Needle