NCT06300801

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
Last Updated

March 8, 2024

Status Verified

February 1, 2024

First QC Date

February 16, 2024

Last Update Submit

March 7, 2024

Conditions

Keywords

albuminpancreatic fistulac- reactive protein

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hitit University Erol olçok Traning and research Hospital

Çorum, Merkez, 19000, Turkey (Türkiye)

Location

Hitit University Erol olçok Traning and resourge Hospital

Çorum, Merkez, 19000, Turkey (Türkiye)

Location

Related 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.

    PMID: 31704858BACKGROUND

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2024

First Posted

March 8, 2024

Last Updated

March 8, 2024

Record last verified: 2024-02

Locations