Clinical and Economic Validation of the ISGPS Definition of PPAP (ISGPS-PPAP)

Integrated University Hospital Trust of Verona

Status: Completed

Conditions: Postoperative Complications; Postoperative Acute Pancreatitis; Postoperative Pancreatic Fistula; Pancreaticoduodenectomy

Treatments: Diagnostic Test: PPAP diagnosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05680623

3822CESC

Details and patient eligibility

About

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.

Full description

The study will be conducted at approximately 37 investigative sites in Europe, Asia, Oceania, and the United States. Only high volume centers for Pancreatic Surgery will be included in the study. 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. The study duration per subject will be up to 30 days after surgery or all the in-hospital lengths of stay. Preoperative care will follow institutional standards, according to each center involved. Surgical resection and reconstruction will be carried out according to the techniques adopted by each participating center. Both patients undergoing open and minimally invasive surgery can be considered eligible. Postoperative management will follow the institutional standards of each center. Serum amylase (total or the pancreatic isoform) and/or lipase activity will be systematically measured at least on postoperative days (POD) 1 and 2.Serum C-reactive protein (CRP) will be measured according to each institutional policy and reported once assessed from POD 1 to 3. Drain fluid amylase, or lipase activity will be checked according to the Institutional standards of each involved, and the values will be retrieved whether assessed from POD 1 to five. Radiological imaging will be performed in the postoperative course when clinically required, facing patients' clinical worsening, suspicious for abdominal complications.The severity of complications will be assessed according to the Clavien-Dindo (CD) classification system 32 . Readmission will be defined as a new hospital admission after discharge within 30 days from index surgery. Length of hospital stay is calculated from the day of surgery to discharge. Preoperative, intra-operative, and postoperative data will be recorded prospectively.

The estimated study duration will be 15 months. Time for data analysis must be considered negligible. Patients' follow-up will last 30 days after surgery to catch any additional morbidity even after discharge from the hospital.

Enrollment: 2,900 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

2,900 participants in 1 patient group

study population

Description:

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.

Treatment:

Diagnostic Test: PPAP diagnosis