Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy

NCT ID: NCT06300801

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Pancreatic Fistula After Pancreaticoduodenectomy; C-Reactive Protein; Albumin

Interventions

Is the preoperative c-reactive protein/albumin ratio successful in predicting postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy?

In this study, predicting pancreatic fistula before surgery will reduce postoperative complications and mortality.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erol Olcok Corum Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bahadır Kartal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hitit University Erol olçok Traning and research Hospital

Çorum, Merkez, Turkey (Türkiye)

Hitit University Erol olçok Traning and resourge Hospital

Çorum, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 31704858 (View on PubMed)

Other Identifiers

hitit

Identifier Type: OTHER

Identifier Source: secondary_id

2023-48

Identifier Type: -

Identifier Source: org_study_id