Viewing Study NCT06300801



Ignite Creation Date: 2024-05-06 @ 8:14 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06300801
Status: NO_LONGER_AVAILABLE
Last Update Posted: 2024-03-08
First Post: 2024-02-16

Brief Title: Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy
Sponsor: Erol Olcok Corum Training and Research Hospital
Organization: Erol Olcok Corum Training and Research Hospital

Study Overview

Official Title: Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy
Status: NO_LONGER_AVAILABLE
Status Verified Date: 2024-02
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: popf
Brief Summary: Pancreaticoduodenectomy PD is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region associated with high morbidity and mortality Postoperative pancreatic fistula POPF is the most common and clinically significant complication following PD In this study the investigators aim to predict pancreatic fistula using the C-reactive protein-albumin ratio CAR The total number of participants expected to be included in this research comprises patients who underwent PD between 2017 and 2023 and developed pancreatic fistula The participants invitation is based on the detection of a pancreatic fistula This study is conducted for research purposes and participation is voluntary No interventions will be performed on the participants as part of this study however we have prepared this form to obtain participant permission to gather certain information If the participants consent to the use of information for scientific purposes with the guarantee of confidentiality they will be asked to sign a consent form
Detailed Description: Pancreaticoduodenectomy PD is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region associated with high morbidity and mortality rates Despite dramatic advancements in surgical techniques and perioperative management reported morbidity and mortality rates following PD are 4156 and 288 respectively which remain unsatisfactory Postoperative pancreatic fistula POPF is the most common and clinically significant complication following PD Therefore accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions The C-reactive protein-albumin ratio CAR is an inflammatory marker calculated by dividing serum CRP levels by albumin levels and has been associated with poor prognosis in sepsis patients This study aimed to investigate the predictive significance of CAR for POPF

Study Oversight

Has Oversight DMC: None
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?: None