Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877340
Status:
UNKNOWN
Last Update Posted:
2021-05-07
First Post:
2021-04-20
Brief Title:
Comparation Between Needles for EUS-guided Sampling of Solid Pancreatic Lesions
Sponsor:
Instituto do Cancer do Estado de São Paulo
Organization:
Instituto do Cancer do Estado de São Paulo
Study Overview
Official Title:
Prospective Randomized Study Comparing the 25-gauge Franseen Needle and the 25-gauge Standard Needle for EUS-guided Fine-needle Sampling of Solid Pancreatic Lesions Without Rapid on Site Evaluation
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 50000 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
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 50000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None