Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-28 @ 7:21 PM
Study NCT ID:
NCT01795066
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2013-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Ultrasound-guided Fine Needle Biopsy With 25-gauge Biopsy Needles for Solid Pancreatic Masses
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-12
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:
None
Brief Summary:
For 12 months after approvement by the University of Yonsei institutional review board, of the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all consecutive pancreatic lesions were evaluated for inclusion in our prospective study. The inclusion criteria for this study were the following: diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies with need of histologic tissue confirmation by EUS-FNA or EUS-FNB. The exclusion criteria were the following: cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 50,000 cells/cubic millimeter \[cmm3\]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study. Patients undergoing anticoagulant or anti- platelet therapy for non-critical problems discontinued treatment at least 5 days before the endoscopic procedure. Written informed consent was obtained from all patients for the procedures performed and participation in the study, and the study protocol was approved by the University of Yonsei institutional review board. All patients were underwent the procedure under conscious sedation with propofol and midazolam according to the current guidelines.8 After procedure, the patients were monitored for at least six hours in order to immediately detect post-procedural complications and were followed for up to 7 days in order to detect late complications.
Detailed Description:
None
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?: