CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
19 G Flex Needle +2 moredevice
Likely dose
19 G Flex Needlefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01711294
NCT01711294N/ACompleted

A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration

Boston Scientific Corporation·interventional·Posted Oct 22, 2012·Updated Jan 15, 2021

In Brief

A clinical study evaluating 19 G Flex Needle, 22 G Needle, and 1 other intervention for Pancreatic Cystic Lesions. Completed, enrolled 250 participants across 8 sites in 3 countries.

Detailed Summary

To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, India, United States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2012
Enrollment StartJan 8, 2013
Primary CompletionJun 6, 2017
Study CompletionDec 18, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 13.7 years ago

Interventions

19 G Flex Needledevice

Fine Needle Aspiration of PCL with a 19 G Flex needle. If unsuccessful, a salvage procedure will be done with 19 G or 22 G needle.

22 G Needledevice

Fine Needle Aspiration of PCL with a 22 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.

19 G Needledevice

Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.