Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04654299
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2020-11-29
Brief Title:
Biliary Externalization After Pancreaticoduodenectomy
Sponsor:
Universidad de Extremadura
Organization:
Universidad de Extremadura
Study Overview
Official Title:
Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy
Status:
COMPLETED
Status Verified Date:
2022-06
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:
Postoperative pancreatic fistulaPOPF is the most common complication of pancreaticoduodenectomy PD Sometimes POPF is associated with biliary fistulaBF or mixed fistula The purpose of this study is to assess whether the severity of the fistulae when present is decreased with an external biliary stent in place
Detailed Description:
n this single-center study we analyze patients who underwent elective PD from January_2014 to December_2017 Patients are divided into two groups standard PD ST-PDvs PD with external biliary stentPD-BS Demographic preoperative intraoperative and postoperative variables will be analyze including complications according to the Clavien-Dindo classification and those specific to pancreatic surgeries and mortality rates within 90 days of operation
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