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2015-04-27
2016-06-23
2016-06-23
1
NCT03111368
University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
INTERVENTIONAL
EUS-FNA of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique
50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle aspiration using two techniques: negative pressure and slow-pull. Cytological results will be compared.
The study will analyze the cytological results of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic mass using two different techniques of needle suction. Negative pressure and slow-pull. 50 patients with pancreatic mass will be submitted to four passes with both techniques. Each patient will be randomized to decide which technique will be first and subsequently on a alternated fashion until four passes are completed. Smear cytology and cell block preparations for each technique were obtained. The pathologist was blinded for the EUS-FNA technique.
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 |
|---|---|---|
2016-04-01 | N/A | 2017-04-11 |
2017-04-11 | N/A | 2017-04-12 |
2017-04-12 | N/A | 2016-06 |
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:
Single Group
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: EUS- FNA Slow-pull Endoscopic ultrasound-guided fine needle aspiration using a stylet slow-pull technique of solid pancreatic mass | PROCEDURE: Endoscopic ultrasound-guided fine needle aspiration
|
| ACTIVE_COMPARATOR: EUS-FNA Negative Pressure Endoscopic ultrasound-guided fine needle aspiration using negative pressure technique of solid pancreatic mass | PROCEDURE: Endoscopic ultrasound-guided fine needle aspiration
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Diagnostic yield | cytological results after endoscopic ultrasound fine needle aspiration | 24 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
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:
18 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
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
