Skip to main content
OpenTrials
Completed

NCT Number: NCT06700330

Etiology, Clinical Picture, Complications and Outcomes of Necrotizing Pancreatitis in Children.

The aim of this research is to study the etiology, the clinical picture, the management, the complications and the outcomes of necrotic pancreatitis in children.

Currently, there is a significant number of errors in the early diagnosis of AP in children associated with the complexity of differential diagnosis, which leads to the untimely verification of the correct diagnosis and, consequently, to incorrect treatment tactics, which could be accompanied by an increase in the severe forms of the disease and an increase in mortality.

Completed

Looking for future studies?

Notify Me

Key information

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

Moscow, Moscow Oblast, 129110, Russia

About this study

Acute pancreatitis (AP) is an acute inflammatory disease of the exocrine pancreas. Clinical manifestations vary from mild abdominal discomfort to metabolic disorders, sepsis, fluid sequestration, multiple organ failure and death. According to the international data, the annual incidence of AP in children is 3-13 cases per 100,000 people, but in recent years, there has been an increase in the incidence of this pathology. Necrotic pancreatitis in children accounts for up to 25-30% of the cases of all forms of AP. Despite the successes achieved in the diagnosis and treatment of AP, the mortality rate for this pathology is up to 5%, according to various authors. In addition, given the varying degrees of the prevalence of the destructive process in the pancreas and the parapancreatic tissue, the choice of surgical treatment still remains a subject of discussion. The treatment of moderately severe (MSAP) and severe (SAP) necrotic pancreatitis is a complex task due to the variety of causes of the disease, the incompletely understood pathogenesis and the uncertainty in predicting the results.

Paralytic ileus with the development of intestinal failure is the main pathogenetic factor in the development of a septic condition in AP, but there is tendency of insufficient attention being paid to this fact in pediatric practice, which determines the lack of a unified approach to the treatment of intestinal failure syndrome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consent of the patient or legal representative
  • Age from 0-18 years
  • Moderate severe (MSAP) or severe acute pancreatitis (SAP) according to Atlanta criteria revisited in 2012
  • Acute Pancreatitis was established in the presence of at least two of three criteria according to the classification developed by the INSPPIRE group (International Study Group of Pediatric Pancreatitis: In Search for a Cure): abdominal pain corresponding to the diagnostic hypothesis; an increase in amylase and / or lipase in the blood serum by ≥3 times; imaging findings characteristic of AP: abdominal ultrasound and/or contrast-enhanced CT.

Exclusion criteria

  • mild acute pancreatitis
  • chronic pancreatitis
  • no consent from patient or legal representative

Treatment and study plan

no intervention, observational study

Other

Only data from the patient file.

Primary outcomes

  1. the frequency of occurrence of various etiologic causes of necrotizing pancreatitis in children

    Time frame: From enrollment to the end of treatment (2 month)

    based on the study, the most common causes of necrotizing pancreatitis in children will be identified

Secondary outcomes

  1. The duration from the onset of the disease to the start of the treatment

    Time frame: from the onset of the disease to the end of treatment (up to 20 weeks)

  2. The duration of hospital stay

    Time frame: from admission to hospital until the end of treatment (up to 8 weeks)

    the effect of each risk factor on the duration of hospital stay

  3. The length of ICU stay

    Time frame: During ICU stay (up to 60 days)

  4. The effect of comorbidities on the severity of the disease

    Time frame: from admission to hospital until the end of treatment (up to 8 weeks)

  5. Intestinal failure

    Time frame: from admission to hospital until the end of treatment (up to 8 weeks)

    the effect of Intestinal failure on the duration of hospital stay

  6. Paralytic ileus

    Time frame: from admission to hospital until the end of treatment (up to 8 weeks)

    the effect of paralytic ileus on the severity of acute pancreatitis and the length of hospital stay

  7. Mortality

    Time frame: from admission to hospital until the end of treatment (up to 20 weeks)

  8. Enzymatic parapancreatitis

    Time frame: from admission to hospital until the end of treatment (up to 10 weeks)

    the effect on severity of the disease and the outcome

  9. Purulent-necrotic parapancreatitis

    Time frame: from admission to hospital until the end of treatment (up to 20 weeks)

    the effect on severity of the disease and the outcome

  10. Biliary obstruction

    Time frame: from admission to hospital until the end of treatment (up to 20 weeks)

  11. Surgical interventions

    Time frame: from admission to hospital until the end of treatment (up to 20 weeks)

Sponsors and collaborators

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Other Gov

Registry information

Official study title

Study of the Etiology, Clinical Picture, Complications and Outcomes of Necrotizing Pancreatitis in Children.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Feb 20, 2025

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.

Published trials that share one or more normalized conditions with this study.