Comparing Biopsy Needles for Endoscopic Ultrasound Guided Samples for Pancreatic Masses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-08-31

Brief Summary

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This is a randomized prospective clinical study comparing a fine needle biopsy device and an aspiration needle.

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Detailed Description

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At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G FNA or FNB needle. All patients will undergo sampling of pancreatic masses using both needles but the needle to be used first will be based on randomization. Subsequent passes will be performed by alternate needles and once onsite diagnosis is established using either needle type, more passes will not be performed for onsite diagnostic adequacy. However, a minimum of at least one pass and a maximum of 8 passes will be performed using both needle types. The number of passes needed to achieve diagnostic adequacy using both needles will documented.

Four dedicated passes will then be performed using the initial randomization sequence for cell block. Two passes will be performed using each needle type and the specimen will be preserved in formalin and sent for cell block processing.

If the doctor cannot obtain enough tissue with the study needles, another needle with a different gauge (19 or 25) will be used. This will also be a maximum of 8 passes. Information about the number of needles used, how many passes were performed, any problems with the needles will be collected. If there is not enough tissue available from these passes to establish a diagnosis, the subject will be asked to come back at another time for a repeat procedure.

Conditions

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Pancreatic Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Acquire EUS Biopsy Device

All patients will undergo sampling of pancreatic masses using the Acquire EUS Biopsy Device. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types.

Group Type ACTIVE_COMPARATOR

Acquire EUS Biopsy Device

Intervention Type DEVICE

1\. At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or Expect EUS Aspiration Needle.

Expect EUS Aspiration Needle

All patients will undergo sampling of pancreatic masses using the Expect EUS Aspiration Needle. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types

Group Type ACTIVE_COMPARATOR

Expect EUS Aspiration Needle

Intervention Type DEVICE

1\. At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or Expect EUS Aspiration Needle.

Interventions

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Acquire EUS Biopsy Device

1\. At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or Expect EUS Aspiration Needle.

Intervention Type DEVICE

Expect EUS Aspiration Needle

1\. At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or Expect EUS Aspiration Needle.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Scheduled to undergo EUS
* Patients with solid pancreatic masses on cross-sectional imaging or with jaundice secondary to biliary obstruction
* Able and willing to provide written or verbal consent

Exclusion Criteria

* Unable to safely undergo EUS for any reason
* Coagulopathy (Prothrombin time \> 18 secs, platelet count \< 80,000/ml)
* Active alcohol or other drug use or significant psychiatric illness
* Pregnancy
* Unable or unwilling to provide consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No