Clinical trial NCT06300801: Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy
Official title: Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Pancreatic Fistula After Pancreaticoduodenectomy
C-Reactive Protein
Albumin
Keywords: albumin
pancreatic fistula
c- reactive protein
Lead sponsor: Erol Olcok Corum Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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 41.56% and 2.88%, 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 80 years
* Diagnosed with pancreatic cancer
* Patients without recurrence

Exclusion Criteria:

* Patients who underwent total pancreatectomy
* Data were not available
* Patients outside the specified age range

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hitit University Erol olçok Traning and research Hospital
state: Merkez
city: Çorum
country: Turkey
facility: Hitit University Erol olçok Traning and resourge Hospital
state: Merkez
Study officials:
References:
citation: Sakamoto T, Yagyu Y, Uchinaka EI, Morimoto M, Hanaki T, Tokuyasu N, Honjo S, Fujiwara Y. Predictive Significance of C-reactive Protein-to-albumin Ratio for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy. Anticancer Res. 2019 Nov;39(11):6283-6290. doi: 10.21873/anticanres.13838.