Evaluation of PCLs Using Three EUS-FNA Needles

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-08

Study Completion Date

2019-12-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Cystic Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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19 G Flex Needle

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

Group Type ACTIVE_COMPARATOR

19 G Flex Needle

Intervention Type DEVICE

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.

22 G Needle

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

Group Type ACTIVE_COMPARATOR

22 G Needle

Intervention Type DEVICE

Fine Needle Aspiration of PCL with a 22 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.

19 G Needle

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

Group Type ACTIVE_COMPARATOR

19 G Needle

Intervention Type DEVICE

Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.

Interventions

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19 G Flex Needle

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

19 G Needle

Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No