Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-01-31

Brief Summary

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The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure.

There are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.

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Detailed Description

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Conditions

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Pancreatic Solid Lesions Pancreatic Mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard suction

These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

Group Type EXPERIMENTAL

Standard technique EUS-FNA

Intervention Type DEVICE

Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

Capillary suction

These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.

Group Type EXPERIMENTAL

Capillary suction technique for EUS FNA

Intervention Type DEVICE

Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously

Interventions

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Standard technique EUS-FNA

Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

Intervention Type DEVICE

Capillary suction technique for EUS FNA

Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA

Exclusion Criteria

* Uncorrectable coagulopathy (INR \> 1.5)
* Uncorrectable thrombocytopenia (platelet \< 50,000)
* Uncooperative patients
* Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
* Refusal to consent form
* Cystic lesions
* Inaccessible lesions to EUS

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No