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

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04361682
• Other study ID #: 27/19 OSS ComEt CBM
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: April 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Inflammatory Response
• Pancreas Cancer
• Pancreatic Fistula
• Pancreatic Neoplasms

Intervention

Procedure:
• Surgical Drain Management

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of PIBs and drains amylase values for Pancreatic Fistula (PF)	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	pre-intervention/ Day 1 after the intervention/up to discharge"