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22 G - 25 G SINS Trial for Pancreatic Masses

NCT02424838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2019-02-15

No results posted yet for this study

Summary

After patients have been screened and have signed informed consent, they will be taken to the endoscopy suite. Once the decision has been made to proceed with Fine Needle Aspiration (FNA), the subject will be randomized to 1 of 4 groups:

* 22 gauge (G) needle with suction
* 25 G needle with suction
* 22 G needle without suction
* 25 G needle without suction

Follow-up Phone Call Phase:

Unit staff will call patients 1 week after the procedure to check if patients had any adverse events from the procedure and this will be recorded onto the dataset.

Conditions

  • Pancreatic Neoplasms

Interventions

PROCEDURE

EUS-FNA of pancreatic masses

EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.

DEVICE

22 gauge needle

DEVICE

25 gauge needle

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Shyam S Varadarajulu, MD · AdventHealth

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-28
Primary Completion
2016-04-03
Completion
2018-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02424838 on ClinicalTrials.gov