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

NCT06700330 | Completed

• 1 other identifier: 16/01.11.2024
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis; Pancreatitis, Acute Necrotizing; Children

Keywords

Pancreatitis; Acute Necrotizing Pancreatitis; Children

Outcome Measures

Primary Outcomes (1)

• the frequency of occurrence of various etiologic causes of necrotizing pancreatitis in children

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

  From enrollment to the end of treatment (2 month)

Secondary Outcomes (11)

• The duration from the onset of the disease to the start of the treatment

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

• The duration of hospital stay

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

• The length of ICU stay

  During ICU stay (up to 60 days)

• The effect of comorbidities on the severity of the disease

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

• Intestinal failure

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

Study Arms (1)

Children with necrotizing pancreatitis

children who have suffered acute pacreatitis

Other: no intervention, observational study

Interventions

no intervention, observational study OTHER

Only data from the patient file.

Children with necrotizing pancreatitis

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Moscow Regional Research and Clinical Institute (MONIKI): lead

Study Sites (1)

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

Moscow, Moscow Oblast, 129110, Russia

Location

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Acute Necrotizing

Interventions

Observation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Dmitriy A Pyhteev, PhD

  Head of the Department of Pediatric Surgery

  STUDY DIRECTOR

• Leonid M Elin

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 21, 2024
• Study Start: December 1, 2024
• Primary Completion: January 10, 2025
• Study Completion: February 18, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)