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2011-07
2011-09
2011-12
56
NCT01394159
AdventHealth
AdventHealth
INTERVENTIONAL
22G FNA Needle vs. 22G ProCore Needle
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-07-12 | 2015-03-18 | 2018-02-09 |
2011-07-13 | 2015-03-30 | 2018-03-09 |
2011-07-14 | 2015-04-01 | 2018-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 22G ProCore biopsy needle Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the standard FNA needle. | PROCEDURE: 22G ProCore biopsy needle
|
| ACTIVE_COMPARATOR: 22G standard FNA needle Using the 22G standard fine needle aspiration needle (FNA) for sampling pancreatic mass lesions, the tissue obtained will be compared to the 22 G ProCore needle. | PROCEDURE: 22G standard FNA needle
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Compare the Median Number of Passes Required to Establish a Diagnosis | 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Diagnosis Achieved With the Needle | 6 months | |
| Technical Failure | Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved | 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
