Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy (popf)

March 7, 2024 updated by: Bahadır Kartal, Erol Olcok Corum Training and Research Hospital
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.

Study Overview

Status

No longer available

Conditions

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.

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erol Olcok Corum Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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