Clinical trialNACompleted
22G FNA Needle vs. 22G ProCore Needle
Randomized Trial Comparing the 22-gauge Aspiration and 22-gauge Biopsy Needles for EUS-guided Sampling of Solid Pancreatic Mass Lesions
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- July 2011
- Expected end
- December 2011
- Enrollment
- 56 participants
- Sites
- 1
- Primary outcomes
- Compare the Median Number of Passes Required to Establish a Diagnosis
- Sponsor
- Other
- Results posted
- 2015-04-01
- Last update
- 9 March 2018
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Brief summary public domain (ClinicalTrials.gov)
The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.
Detailed description public domain (ClinicalTrials.gov)
In this randomized trial, the 22G standard fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Compare the Median Number of Passes Required to Establish a Diagnosis [6 months]. Median, No. of passes for diagnosis (Inter-Quartile Range). 22G ProCore Biopsy (n=28): 1 (1 to 1); 22G FNA Needle (n=28): 1 (1 to 2.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Diagnosis Achieved With the Needle [6 months]. Number, participants. 22G ProCore Biopsy (n=28): 25; 22G FNA Needle (n=28): 28.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Technical Failure [6 months]. Number, participants. 22G ProCore Biopsy (n=28): 1; 22G FNA Needle (n=28): 0.