NCT02072915

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

February 25, 2014

Last Update Submit

November 7, 2014

Conditions

Solid Pancreatic Mass Lesions

Outcome Measures

Primary Outcomes (1)

  • Number of passes

    once at baseline

Study Arms (2)

Suction

EXPERIMENTAL

Suction will be applied to patients undergoing EUS-FNA

Procedure: Suction

Without suction

NO INTERVENTION

No suction will be applied to patients undergoing EUS-FNA

Interventions

SuctionPROCEDURE
Suction

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Suction

Intervention Hierarchy (Ancestors)

DrainageSurgical Procedures, Operative

Study Officials

  • Jayapal Ramesh, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 27, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

US(1)