Clinical and Economic Validation of the ISGPS Definition of PPAP

NCT05680623 | Completed DMC

• 1 other identifier: 3822CESC
• Study Type: observational
• Target: 2,900
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pancreatitis; hyperamylasemia; pancreatoduodenectomy; postoperative complications; pancreatic fistula

Outcome Measures

Primary Outcomes (4)

• The incidence of PPAP

  The incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system.

  30 postoperative days

• The incidence of unplanned ICU admissions and hospital readmission in the PPAP group compared to the non-PPAP one.

  Only an unplanned need for intensive care will be defined as intensive care unit (ICU) stay. Readmission will be defined as a new hospital admission after discharge within 30 days from index surgery.

  30 postoperative days

• The difference in length of hospital stay between the PPAP and the non-PPAP group

  Length of hospital stay is calculated from the day of surgery to discharge.

  up to hospital discharge, an average of 30 postoperative days

• The difference in hospital costs among the different grades of severity according to the ISGPS grading system22: no PPAP or POH, POH, PPAP grade B, and PPAP grade C groups.

  Total hospital costs will comprise the cost of the index admission and every surgery-related readmission within 30 days from the index surgery. Costs will be inflation-adjusted using the standardized national consumer price index and normalized to adjust the variability inherent to different health systems and institutions.

  30 postoperative days

Secondary Outcomes (4)

• Correlation between postoperative serum amylase/serum lipase activity (U/L) and radiologic feature consistent with PPAP retrieved at postoperative imaging.

  30 postoperative days

• Incidence and descriptive analysis of radiological features consistent with PAPP at postoperative imaging retrieved at different time points.

  30 postoperative days

• Incidence and severity of postoperative morbidity.

  30 postoperative days

• Incidence of postoperative mortality.

  30 postoperative days

Study Arms (1)

study population

Subgroups based on the ISGPS diagnostic criteria and the grading system of PPAP: 1. Without PPAP or POH: Patients without POH nor imaging consistent with AP. 2. POH: sustained postoperative serum hyperamylasemia neither clinically relevant nor consistent imaging 3. PPAP: requiring the fulfilment of three criteria: * POH: sustained serum hyperamylasemia greater than the institutional upper limit of normal persisting on postoperative days 1 and 2; * macroscopic radiologic features of AP * clinically relevant complications. PPAP severity will be classified into grades B and C, with progressive clinical deterioration.

Diagnostic Test: PPAP diagnosis

Interventions

PPAP diagnosis DIAGNOSTIC_TEST

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.

study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients scheduled to receive elective pancreaticoduodenectomy (PD - Kausch-Whipple or Longmire-Traverso) for all type of pancreatic disease (benign, malignant, or premalignant) will be enrolled.

You may qualify if:

• Scheduled for elective PD;
• Male and females ≥ 18 years;
• Upfront or after neoadjuvant therapy surgery is allowed;
• The ability of the subject to understand the character and individual consequences of the clinical trial;
• Written informed consent.

You may not qualify if:

• Patients undergoing emergency surgery;
• Informed consent withdrawal;
• Inability to perform the resection for any reason;
• Total or distal pancreatectomy.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• Heidelberg University: collaborator
• Catholic University of the Sacred Heart: collaborator
• Hospices Civils de Lyon: collaborator
• Lund University: collaborator
• Flinders Medical Centre: collaborator
• Amsterdam UMC, location VUmc: collaborator
• University of Dublin, Trinity College: collaborator
• Christchurch Hospital: collaborator
• University of Colorado, Denver: collaborator
• Scientific Institute San Raffaele: collaborator
• University of Graz: collaborator
• Technical University of Munich: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• San Gerardo Hospital: collaborator
• University of Liverpool: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Massachusetts General Hospital: collaborator
• Kyushu University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Petz Aladar County Teaching Hospital: collaborator
• Mayo Clinic: collaborator
• Hospital Miguel Servet: collaborator
• Tata Memorial Hospital: collaborator
• Medical University of Vienna: collaborator
• Kyoto University, Graduate School of Medicine: collaborator
• UnitedHealth Group: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Thomas Jefferson University: collaborator
• Humanitas Hospital, Italy: collaborator
• Indiana University Health: collaborator
• University of Manchester: collaborator
• New York University: collaborator

Study Sites (1)

Giovanni Marchegiani

Verona, 37134, Italy

Location

Related Publications (5)

• Marchegiani G, Barreto SG, Bannone E, Sarr M, Vollmer CM, Connor S, Falconi M, Besselink MG, Salvia R, Wolfgang CL, Zyromski NJ, Yeo CJ, Adham M, Siriwardena AK, Takaori K, Hilal MA, Loos M, Probst P, Hackert T, Strobel O, Busch ORC, Lillemoe KD, Miao Y, Halloran CM, Werner J, Friess H, Izbicki JR, Bockhorn M, Vashist YK, Conlon K, Passas I, Gianotti L, Del Chiaro M, Schulick RD, Montorsi M, Olah A, Fusai GK, Serrablo A, Zerbi A, Fingerhut A, Andersson R, Padbury R, Dervenis C, Neoptolemos JP, Bassi C, Buchler MW, Shrikhande SV; International Study Group for Pancreatic Surgery. Postpancreatectomy Acute Pancreatitis (PPAP): Definition and Grading From the International Study Group for Pancreatic Surgery (ISGPS). Ann Surg. 2022 Apr 1;275(4):663-672. doi: 10.1097/SLA.0000000000005226.

  PMID: 34596077 BACKGROUND

• Bannone E, Andrianello S, Marchegiani G, Masini G, Malleo G, Bassi C, Salvia R. Postoperative Acute Pancreatitis Following Pancreaticoduodenectomy: A Determinant of Fistula Potentially Driven by the Intraoperative Fluid Management. Ann Surg. 2018 Nov;268(5):815-822. doi: 10.1097/SLA.0000000000002900.

  PMID: 30004917 BACKGROUND

• Loos M, Strobel O, Dietrich M, Mehrabi A, Ramouz A, Al-Saeedi M, Muller-Stich BP, Diener MK, Schneider M, Berchtold C, Feisst M, Hinz U, Mayer P, Giannakis A, Schneider D, Weigand MA, Buchler MW, Hackert T. Hyperamylasemia and acute pancreatitis after pancreatoduodenectomy: Two different entities. Surgery. 2021 Feb;169(2):369-376. doi: 10.1016/j.surg.2020.07.050. Epub 2020 Sep 25.

  PMID: 32981689 BACKGROUND

• Chen H, Wang W, Ying X, Deng X, Peng C, Cheng D, Shen B. Predictive factors for postoperative pancreatitis after pancreaticoduodenectomy: A single-center retrospective analysis of 1465 patients. Pancreatology. 2020 Mar;20(2):211-216. doi: 10.1016/j.pan.2019.11.014. Epub 2019 Nov 27.

  PMID: 31831390 BACKGROUND

• Partelli S, Tamburrino D, Andreasi V, Mazzocato S, Crippa S, Perretti E, Belfiori G, Marmorale C, Balzano G, Falconi M. Implications of increased serum amylase after pancreaticoduodenectomy: toward a better definition of clinically relevant postoperative acute pancreatitis. HPB (Oxford). 2020 Nov;22(11):1645-1653. doi: 10.1016/j.hpb.2020.03.010. Epub 2020 Apr 11.

  PMID: 32291175 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Pancreatitis; Hyperamylasemia; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical

Study Officials

• Giovanni Marchegiani

  Azienda Ospedaliera Universitaria Integrata di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: January 11, 2023
• Study Start: January 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: January 12, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

IT (1)