The Study of the Natural Way of Development of External Pancreatic Fistulas in Children with Necrotizing Pancreatitis

NCT06706440 | Completed

• 1 other identifier: 16/05.11.2024
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The external pancreatic fistula (EPF) is characterized by the leakage of pancreatic juice outward through an area of skinor through a drainage tube. The leakage of pancreatic juice occurs due to the rupture of the pancreatic duct (PD) caused by the destruction of pancreatic tissue. EPF can cause deterioration in the patient's condition due to the leakage of protein-rich pancreatic juice outward, as well as the increased risk of skin irritation and infection.

Conditions

Children; Pancreatic Fistula; Pancreatitis,Acute Necrotizing; Pancreatitis, Acute

Keywords

Children; Acute necrotizing pancreatitis; Pancreatic fistula

Outcome Measures

Primary Outcomes (1)

• The duration of pancreatic fistula functioning

  based on testing serum lipase and/or amylase concentrations in drained fluid, imaging results: ultrasound (US), spiral computed tomography (SCT), magnetic resonance imaging (MRI), fistolography

  From the day of surgery to the end of treatment (9 months)

Secondary Outcomes (7)

• The level of damage to the main pancreatic duct

  From the day of surgery to the end of treatment (9 months)

• The duration of hospital stay

  From the day of surgery to the end of treatment (9 months)

• The mortality

  From enrollment to the end of treatment (9 month)

• The dynamics of the total protein

  From enrollment to the end of treatment (9 month)

• The effect of the etiologic factor on the duration of the external pancreatic fistula functioning

  From enrollment to the end of treatment (9 month)

Study Arms (1)

children with external pancreatic fistula

children who have suffered acute necrotizing pacreatitis and undergone drainage of parapancreatic accumulations, with the development of an external pancreatic fistula

Other: no intervention, observational study

Interventions

no intervention, observational study OTHER

Only data will be taken of patient's file.

children with external pancreatic fistula

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:

• Patient or legal representative consent
• External pancreatic fistula
• Age from 0-18 years
• Moderate severe (MSAP) or severe acute pancreatitis (SAP) according to Atlanta criteria revisited in 2012
• Acute Pancreatitis was defined in case of the presence of at least two of the three criteria according to the classification developed by the INSPPIRE (International Study Group of Pediatric Pancreatitis: In Search for a Cure) group: abdominal pain consistent with the diagnostic hypothesis; serum amylase and/or lipase increased by ≥3 times; imaging results typical 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, 129110, Russia

Location

MeSH Terms

Conditions

Pancreatic Fistula; Pancreatitis, Acute Necrotizing; Pancreatitis

Interventions

Observation

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Dmitriy А 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: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 26, 2024
• Study Start: November 11, 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)