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2020-11-26
2022-11
2023-04
50
NCT04877340
Instituto do Cancer do Estado de São Paulo
Instituto do Cancer do Estado de São Paulo
INTERVENTIONAL
Comparation Between Needles for EUS-guided Sampling of Solid Pancreatic Lesions
This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.
This is a randomized trial conducted at a unique center. The aim of this study is to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate. Patients with a suspected solid pancreatic lesion larger than 15 mm, identified by CT or MRI and referred to EUS-guided sampling will be eligible for inclusion. Patients will be excluded in case of cystic lesion, or the lesion was not detected in EUS, or if the coagulation parameters are abnormal (INR> 2, platelet count < 50,000). The pancreatic mass will be puncture, for expert endoscopist, firstly with a needle according to randomization, followed by another one. Will be make a touch print with the specimen obtained with the needles and, subsequently, all the specimen will be put in formaldehyde solution for cell-block analysis. Diagnostic yield of cell block will be defined as enough histologic tissue core containing pancreatic parenchyma or tumor with dysplastic cells enough for the correct tissue diagnosis. In the presence of malignant tissue in core specimens, it will be calculated the proportion of the area positive for malignancy compared to the total area of the core and then the each needle yield will be defined.
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 |
|---|---|---|
2021-04-20 | N/A | 2021-05-03 |
2021-05-03 | N/A | 2021-05-07 |
2021-05-07 | N/A | 2021-05 |
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:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Standard FNA 22G needle The pancreatic mass will be puncture, for expert endoscopist, with a standard FNA 22G needle | DEVICE: needle punction
|
| EXPERIMENTAL: Franseen 22G needle The pancreatic mass will be puncture, for expert endoscopist, with a FNB 22G needle. The sequence of the use of needles will be randomized. | DEVICE: needle punction
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Compare the diagnostic yield | compare the diagnostic yield between two EUS needles | 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| extra passes with each needle | number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry | 2 years |
| perform immunohistochemistry | need to perform immunohistochemistry to reach the result | 2 years |
| adverse event rate | to assess the adverse event rate | 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: FAUZE MALUF-FILHO, PHD Phone Number: +55 (11)38932000 Email: fauze.maluf@terra.om.br |
Study Contact Backup Name: GABRIELA PADUANI, MD Phone Number: +55(11)944605119 Email: gabrielapaduani@gmail.com |
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
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.
