22 G - 25 G SINS Trial for Pancreatic Masses

Completed · Not applicable

Conditions studied: Pancreatic Neoplasms

In brief

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.

Key facts

Study ID

NCT02424838

Run by

AdventHealth

People needed

352

Starts

2014-07-28

Expected to finish

2018-09-30

Last updated by the study team

2019-02-15

Who can join

Age: 19 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA
• Age ≥ 19 years

You may not qualify if…

• Age <19 years
• Unable to safely undergo EUS for any reason
• Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <80,000/ml)
• Unable to provide consent for any reason
• Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)

Where it is running

• Florida Hospital — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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