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EUS-FNA With and Without Suction

NCT ID: NCT02072915

Last Updated: 2014-11-10

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-05-31

Brief Summary

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To compare the number of passes required for cellblock acquisition with and without suction using the 25g needle.

Detailed Description

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Conditions

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Solid Pancreatic Mass Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Suction

Suction will be applied to patients undergoing EUS-FNA

Group Type EXPERIMENTAL

Suction

Intervention Type PROCEDURE

Without suction

No suction will be applied to patients undergoing EUS-FNA

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Suction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients referred to UAB Endoscopy Unit for assessment of pancreatic mass lesions that requires FNA.

Exclusion Criteria

* Age \< 19 years

* Unable to safely undergo EUS for any reason
* Coagulopathy (INR\>1.6, Prothrombin Time\>18 secs, Thrombocytopenia \< 80,000 cells/ml)
* Unable to consent
* Non-English speaking patients
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayapal Ramesh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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UAB

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F131108005

Identifier Type: -

Identifier Source: org_study_id