Preoperative Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Pancreatic Fistula After Pancreaticoduodenectomy

Completed

• Conditions: Inflammatory Response; Pancreatic Fistula; Pancreas Cancer

• Registration Number: NCT04361682
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

Particularly, pancreatic fistula is the most common and serious complication after pancreaticoduodenectomy (PD) and is reported in up to 40% of cases. The aim of this retrospective single-center study was to investigate the utility of the combination of preoperative inflammation biomarkers (PIBs) with postoperative day 1 drains amylase (POD1-d.a.) levels in predicting grade C Pancreatic Fistula (PF).

Detailed Description

Data from a prospective collected database of 317 consecutive PDs performed at the University Campus Bio-Medico di Roma during the years 2005-2019, have been retrospectively analyzed. Local Ethical Committee approved the study.

Patients undergoing PD for periampullary neoplasms were included in the study. All patients underwent to PD with pancreaticojejunostomy reconstruction. Two surgical drains were always placed at the end of the surgery.

Data regarding PIBs, as full blood count including white blood cell (WBC) count, lymphocytes, neutrophils and platelets counts, neutrophil-to-lymphocyte ratio (NLR), derived neutrophil-to-lymphocyte ratio (d-NLR), platelet-to-lymphocyte ratio (PLR) and POD1-d.a. levels were collected and Positive Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop PF combining PIBs and drains amylase values.

Study Timeline

• Study Start: 2005-01-01
• Primary Completion: 2019-12-31
• Status Verified: 2020-04
• Study Completion: 2020-04-01
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

• Patients underwent pancreaticoduodenectomy (PD) for periampullary neoplasms
• Patients underwent PD with pancreaticojejunostomy reconstruction.
• Patient with data of blood count in first postoperative day

Exclusion Criteria

• None of the above criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive value of PIBs and drains amylase values for Pancreatic Fistula (PF)	pre-intervention/ Day 1 after the intervention/up to discharge"	Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop Pancreatic Fistula (PF) combining PIBs and Postoperative Day 1 Drain Amylase Value