Clinical trial NCT06700330: Etiology, Clinical Picture, Complications and Outcomes of Necrotizing Pancreatitis in Children.
Official title: Study of the Etiology, Clinical Picture, Complications and Outcomes of Necrotizing Pancreatitis in Children.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis
Pancreatitis, Acute Necrotizing
Children
Keywords: Pancreatitis
Acute Necrotizing Pancreatitis
Children
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
First posted: 2024-11-21
Enrollment: 102
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the frequency of occurrence of various etiologic causes of necrotizing pancreatitis in children
timeFrame: From enrollment to the end of treatment (2 month)
Secondary outcomes:
measure: The duration from the onset of the disease to the start of the treatment
timeFrame: from the onset of the disease to the end of treatment (up to 20 weeks)
measure: The duration of hospital stay
timeFrame: from admission to hospital until the end of treatment (up to 8 weeks)
measure: The length of ICU stay
timeFrame: During ICU stay (up to 60 days)
measure: The effect of comorbidities on the severity of the disease
timeFrame: from admission to hospital until the end of treatment (up to 8 weeks)
measure: Intestinal failure
timeFrame: from admission to hospital until the end of treatment (up to 8 weeks)
measure: Paralytic ileus
timeFrame: from admission to hospital until the end of treatment (up to 8 weeks)
measure: Mortality
timeFrame: from admission to hospital until the end of treatment (up to 20 weeks)
measure: Enzymatic parapancreatitis
timeFrame: from admission to hospital until the end of treatment (up to 10 weeks)
measure: Purulent-necrotic parapancreatitis
timeFrame: from admission to hospital until the end of treatment (up to 20 weeks)
measure: Biliary obstruction
timeFrame: from admission to hospital until the end of treatment (up to 20 weeks)
measure: Surgical interventions
timeFrame: from admission to hospital until the end of treatment (up to 20 weeks)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
state: Московская область
Study officials:
affiliation: Head of the Department of Pediatric Surgery
name: Dmitriy A Pyhteev, PhD
role: STUDY_DIRECTOR
affiliation: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
name: Leonid M Elin
role: PRINCIPAL_INVESTIGATOR
References: