NCT04294797

Brief Summary

The study investigates the local and systemic inflammatory response following pancreatic resections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
Last Updated

March 4, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

March 2, 2020

Last Update Submit

March 2, 2020

Conditions

Postoperative Complications

Keywords

Pancreatic resectionPOPFInflammatory response

Outcome Measures

Primary Outcomes (1)

  • Presepsin

    Correlation of Presespin values with postoperative complications, especially POPF.

    Preoperative until postoperative day 8.

Secondary Outcomes (1)

  • Biomarker assessment

    Preoperative until postoperative day 8.

Interventions

Blood drawDIAGNOSTIC_TEST

One additional blood sample for study purpose from the day before surgery, postoperative 1, 3 and 8.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with any pancreatic pathology (benign and malign) requiring surgery
  • Written informed consent
  • \>= 18 years

You may not qualify if:

  • Pregnancy
  • Patients who are not capable of giving informed consent (e.g. with existing medical trustee)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (1)

  • Gasteiger S, Primavesi F, Gobel G, Braunwarth E, Cardini B, Maglione M, Sopper S, Ofner D, Stattner S. Early Post-Operative Pancreatitis and Systemic Inflammatory Response Assessed by Serum Lipase and IL-6 Predict Pancreatic Fistula. World J Surg. 2020 Dec;44(12):4236-4244. doi: 10.1007/s00268-020-05768-9. Epub 2020 Sep 8.

    PMID: 32901324DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 4, 2020

Study Start

July 11, 2017

Primary Completion

August 26, 2019

Study Completion

December 31, 2019

Last Updated

March 4, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)