Clinical and Economic Validation of the ISGPS Definition of PPAP

Summary

This prospective validation study aims to investigate the incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system, to demonstrate its clinical impact by examining associated postoperative outcomes, and to validate its applicability through an economic assessment.

Conditions

• Postoperative Acute Pancreatitis
• Pancreaticoduodenectomy
• Postoperative Pancreatic Fistula
• Postoperative Complications

Interventions

DIAGNOSTIC_TEST

PPAP diagnosis

Serum amylase (total or the pancreatic isoform) and/or lipase activity will be systematically measured at least on postoperative days 1 and 2. A CT with pancreas protocol iv contrast infusion will be performed in the postoperative course when clinically required, facing patients' clinical worsening, suspicious of abdominal complications.

Sponsors & Collaborators

• Heidelberg University

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• Lund University

  collaborator OTHER

• Flinders Medical Centre

  collaborator OTHER_GOV

• Amsterdam UMC, location VUmc

  collaborator OTHER

• University of Dublin, Trinity College

  collaborator OTHER

• Christchurch Hospital

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Scientific Institute San Raffaele

  collaborator OTHER

• University of Graz

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• San Gerardo Hospital

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Kyushu University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Petz Aladar County Teaching Hospital

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Hospital Miguel Servet

  collaborator OTHER

• Tata Memorial Hospital

  collaborator OTHER_GOV

• Medical University of Vienna

  collaborator OTHER

• Kyoto University, Graduate School of Medicine

  collaborator OTHER

• UnitedHealth Group

  collaborator INDUSTRY

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• Humanitas Hospital, Italy

  collaborator OTHER

• Indiana University Health

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• New York University

  collaborator OTHER

• Azienda Ospedaliera Universitaria Integrata Verona

  lead OTHER

Principal Investigators

• Giovanni Marchegiani · Azienda Ospedaliera Universitaria Integrata di Verona

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2023-09-30

Completion

2024-01-12

Countries

• Italy

Study Locations