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2012-08
2013-01
2013-01
72
NCT01677312
AdventHealth
AdventHealth
INTERVENTIONAL
Trial Comparing 19 and 25-gauge EUS-FNA Needles
This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.
The study compares the median number of passes to establish a definitive diagnosis using the 19G or 25G needles. Also, the ability of both needles to procure a histological core tissue is assessed.
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 |
|---|---|---|
2012-08-28 | 2015-03-31 | 2020-03-03 |
2012-08-29 | 2020-03-03 | 2020-03-17 |
2012-09-03 | 2020-03-17 | 2020-03 |
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:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 19G FNA needle Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy. | PROCEDURE: Pancreatic Biopsy
PROCEDURE: Histological Samples
|
| ACTIVE_COMPARATOR: 25G FNA needle Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy. | PROCEDURE: Pancreatic Biopsy
PROCEDURE: Histological Samples
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Median Number of Passes to Establish Diagnosis | To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types. | 5 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Procurement of Histological Samples | The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined. | 30 days |
| Needle Dysfunction | The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient. | 2 hours |
| Complications | The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation. | 30 days |
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
No publications available
