Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy

C-Reactive Protein Clinical Trial

— popf  

Official title:

Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT06300801
• Other study ID #: 2023-48
• Status: No longer available

Study information

• Verified date: February 2024
• Source: Erol Olcok Corum Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• C-Reactive Protein
• Fistula
• Pancreatic Fistula
• Pancreatic Fistula After Pancreaticoduodenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erol Olcok Corum Training and Research Hospital

References & Publications (1)

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. — View Citation