Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02078232
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2014-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis
Sponsor:
French Society of Digestive Endoscopy
Organization:
Study Overview
Official Title:
Randomized, Comparative Study of 19G Flex Versus 22G Standard Needles for Pancreatic Solid Tumors Diagnosis.
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
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:
EASYFLEX
Brief Summary:
The purpose of this study is to compare the diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.
Detailed Description:
The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic masses is about 70 - 80 % with the 22G standard needle. Pancreatic adenocarcinoma is known to have a severe prognosis and a low rate of survival even after curative surgery. The study of pancreatic solid tumors is one the main diagnostic problem present in the investigators daily practice. In most of non operated patients, EUS-FNA is the sole possibility to confirm the diagnosis of malignancy which is required to initiate chemotherapy and/or radiotherapy. To improve the performances of the EUS-FNA, new needles are now disposable either with a cutting window design (EchoTip ProCore-COOK Medical) or flexible 19G needle (19G Expect Flex - Boston-Scientific). The goal is to obtain more tissue material with the possibility of a histologic study without increasing the risk of the puncture which is very low (complications rate \< 1%). The problem concerns the lesion of the head of the pancreas requiring a trans-duodenal access for the puncture . In this position, the needle is very difficult to push out the operator channel and, in some cases, the puncture is quite impossible with stiff needles as "ProCore" or standard 19G. Thus, the interest of flexible 19G needle is to be used in difficult technical cases as transduodenal access for head pancreatic tumors, with a good safety and more efficacy than 22G needles.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: