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NCT Number: NCT04917172

Post-Operative Acute Pancreatitis After Pancreaticoduodenectomy

The occurrence of post-pancreatectomy acute pancreatitis (PPAP) can critically impact outcomes after pancreaticoduodenectomy. Although diagnosing a PPAP can be challenging, its identification appears crucial as it can trigger additional morbidity. However, due to the early onset in the perioperative period, the actual spectrum of its early phases has not been systematically explored yet. For this reason, the present study will compare some early biochemical evidence of pancreatic stump damage to morphological changes evident at postoperative imaging.

The postoperative evaluation of serum and/or urine pancreatic enzymes and the radiologic assessment are included in everyday clinical practice. However, the timing and the clinical relevance of such findings mostly rely on the single-institution experience.

This study aims to characterize PPAP by investigating its early radiologic, biochemical, and clinical spectrum of either local or systemic changes associated.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Verona University Hospital

Verona, VR, 37134, Italy

About this study

The occurrence of an acute inflammatory process of the pancreatic parenchyma after pancreatic resections has been reported in the literature, but the actual existence of a clinically evident post-pancreatectomy acute pancreatitis (PPAP), defined as a distinct postoperative complication, has been traditionally challenged or, at least, considered to be a rare event.

Emerging evidence, however, defines PPAP as an acute inflammatory/ischemic condition of the pancreatic remnant, able to trigger further postoperative morbidity.

The assessment of ischemic damage of the organ subjected to surgery was also evaluated in other scenarios, such as for the post-cardiac surgery myocardial infarction (MI) and the post-neurosurgery stroke. These ischemic complications, besides having well-defined biochemical features, maybe detected early on post-operative magnetic resonance imaging (MRI). The decrease of pancreatic perfusion may, in some instances, lead to an altered signal in diffusion-weighted images (DWI) and apparent diffusion coefficient (ADC) maps. DWI MRI with Intravoxel incoherent motion (IVIM) sequences have also recently emerged as a key tool to provide quantitative estimates of physiological parameters associated with perfusion and permeability in vivo and can provide information on alterations of tissue cellularity, membrane-cell integrity, and the extracellular space.

The recent PPAP definition has left some unsolved issues, including the need to investigate the role of lipases as a diagnostic criterion, the actual spectrum of PPAP complications, the proper timing for postoperative radiological evaluation, and the preferred imaging modality for PPAP assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and females ≥ 18 years;
  • Scheduled for elective PD;
  • ASA score < 4;
  • High-quality preoperative cross-sectional imaging of the abdomen performed roughly within one month before surgery;
  • Upfront or after neoadjuvant therapy surgery is allowed;
  • Ability of the subject to understand the character and individual consequences of the clinical trial;
  • Written informed consent.

Exclusion criteria

  • Patients undergoing emergency surgery;
  • Patients with high serum pancreatic amylase or lipase before surgery;
  • Chronic use of steroids;
  • Informed consent withdrawal;
  • Pancreaticogastrostomy (PG);
  • Use of octreotide analogs;
  • Inability to perform the resection for any reason;
  • Total or distal pancreatectomy;
  • Need to extend the resection to the pancreas body for any reason.
  • Inability to undergo MRI because of contraindications (e.g. claustrophobia, presence of non-MRI-compatible metal implants)

Treatment and study plan

postoperative acute pancreatitis evaluation

Diagnostic Test

Surgical resection and reconstruction will be carried out according to the Institutional standards. After the surgical procedure, serum pancreatic amylase and lipase activity will be systematically measured two hours after surgery on postoperative day (POD) 0 and every day at 7 a.m. until POD 5 according to our institutional policy. At our institution, the upper limit of normal for serum pancreatic amylase is 52 U/L and for serum lipase is 60 U/L. Postoperative protocols included the routine measurement of inflammatory markers (white blood cell [WBC] count and C-Reactive Protein [CRP]). A urine trypsinogen strip test will be done on POD 1. A trypsinogen-2 concentration of more than 50 µg/l is considered a positive test. As routine clinical practice, a post-operative imaging will be scheduled to check for potential surgical morbidity. Abdominal magnetic resonance imaging (MRI) will be assessed on POD 3.

Primary outcomes

  1. the difference in apparent diffusion coefficient (ADC) values at diffusion-weighted (DW) MRI in the PPAP group compared to patients without PPAP.

    Time frame: postoperative day 3 (72 h after the index surgery).

    DW-MRI studies will be performed on a 1.5 T scanner using a multi-channel phased-array torso coil.

Secondary outcomes

  1. intraindividual correlation between longitudinal assessment of serum pancreatic enzymes

    Time frame: 5 days after surgery

    correlation between repeated measurements of serum pancreatic amylase and lipase activity.

  2. postoperative acute pancreatitis and morbidity

    Time frame: 90 days after surgery

    to assess the correlation between the incidence of postoperative acute pancreatitis and the % of patients with postoperative morbidity (scored with the Clavien Dindo Classification of surgical complications)

  3. Postoperative acute pancreatitis incidence

    Time frame: 90 days after surgery

    PPAP as defined by ISGPS

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

Post-Operative Acute Pancreatitis After Pancreaticoduodenectomy: A Prospective Study in the Setting of a High-volume Center.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2021
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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