Preoperative POPF risk factors after pancreatoduodenectomy

• Conditions: All patients who underwent surgery for malignant or benign pancreatic disease in the years 2001 to 2019 in the Department of General and Visceral Surgery at Freiburg University Hospital and have fully documented preoperative diagnostics, laboratory parameters, postoperative course were included. All entities that have received pancreatoduodenectomy will be considered.

• Registration Number: DRKS00032534
• Lead Sponsor: niklinik Freiburg, Department für Allgemein- und Viszeralchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 661

Inclusion Criteria

Patients who have undergone surgery for a malignant or benign disease of the pancreas in the years 2001 to 2019 in the Department of General and Visceral Surgery at Freiburg University Hospital and have fully documented preoperative diagnostics, laboratory parameters and postoperative course are eligible for inclusion. All entities that have undergone pancreatoduodenectomy will be considered.

Exclusion Criteria

None.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of sensitivity, specificity, positive-predictive value, and negative-predictive value of various preoperative laboratory parameters and preoperative pancreatic ductal width using radiologic imaging for early detection of POPF risk.<br>Evaluation of pancreatic parenchymal fibrosis and POPF rate in patients with and without elevated tumor marker CA-19-9.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the other possible risk factors:<br><br>1. sociodemographic data (age, sex, ASA score, BMI, previous diseases). <br>2. disease-specific data (entity, duration of disease, previous treatment, clinical symptoms, preoperative laboratory parameters) <br>3. surgical method as well as postoperative complications (according to Clavien-Dindo as well as occurrence of pancreatic typical complications like fistulas)<br>4. histomorphological data (entity, acinar cell atrophy, fibsosis rate and inflammation percentage) <br>5. length of hospital stay as well as length of intensive care stay.