Etiology, Clinical Picture, Complications and Outcomes of Necrotizing Pancreatitis in Children.
Study of the 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Московская область
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Moscow, Московская область, Russian Federation, 129110
- Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Children with necrotizing pancreatitis
children who have suffered acute pacreatitis
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Only data from the patient file.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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the frequency of occurrence of various etiologic causes of necrotizing pancreatitis in children
Time Frame: From enrollment to the end of treatment (2 month)
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based on the study, the most common causes of necrotizing pancreatitis in children will be identified
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From enrollment to the end of treatment (2 month)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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from the onset of the disease to the end of treatment (up to 20 weeks)
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|
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The duration of hospital stay
Time Frame: from admission to hospital until the end of treatment (up to 8 weeks)
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the effect of each risk factor on the duration of hospital stay
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from admission to hospital until the end of treatment (up to 8 weeks)
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The length of ICU stay
Time Frame: During ICU stay (up to 60 days)
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During ICU stay (up to 60 days)
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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)
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from admission to hospital until the end of treatment (up to 8 weeks)
|
|
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Intestinal failure
Time Frame: from admission to hospital until the end of treatment (up to 8 weeks)
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the effect of Intestinal failure on the duration of hospital stay
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from admission to hospital until the end of treatment (up to 8 weeks)
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Paralytic ileus
Time Frame: from admission to hospital until the end of treatment (up to 8 weeks)
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the effect of paralytic ileus on the severity of acute pancreatitis and the length of hospital stay
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from admission to hospital until the end of treatment (up to 8 weeks)
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Mortality
Time Frame: from admission to hospital until the end of treatment (up to 20 weeks)
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from admission to hospital until the end of treatment (up to 20 weeks)
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Enzymatic parapancreatitis
Time Frame: from admission to hospital until the end of treatment (up to 10 weeks)
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the effect on severity of the disease and the outcome
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from admission to hospital until the end of treatment (up to 10 weeks)
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Purulent-necrotic parapancreatitis
Time Frame: from admission to hospital until the end of treatment (up to 20 weeks)
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the effect on severity of the disease and the outcome
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from admission to hospital until the end of treatment (up to 20 weeks)
|
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Biliary obstruction
Time Frame: from admission to hospital until the end of treatment (up to 20 weeks)
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from admission to hospital until the end of treatment (up to 20 weeks)
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Surgical interventions
Time Frame: from admission to hospital until the end of treatment (up to 20 weeks)
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from admission to hospital until the end of treatment (up to 20 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Leonid M Elin, Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
- Study Director: Dmitriy A Pyhteev, PhD, Head of the Department of Pediatric Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/01.11.2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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