Skip to main content
OpenTrials
Completed

NCT Number: NCT04361682

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Fistula Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fistula Inflammatory Response Neoplasms Neoplasms by Site Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Drain Management

Procedure

Primary outcomes

  1. Predictive value of PIBs and drains amylase values for Pancreatic Fistula (PF)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Preoperative Systemic Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Grade C Pancreatic Fistula After Pancreaticoduodenectomy: a Retrospective Single Center Experience

Important dates

Study start
2005
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.