CompletedNot Applicable

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

Russia26 participantsStarted 2024-11-11

Plain-language 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.

Who can participate

Age range0 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Mild acute pancreatitis * Chronic pancreatitis * No consent from patient or legal representative

What they're measuring

The duration of pancreatic fistula functioning

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

Trial details

NCT IDNCT06706440

SponsorMoscow Regional Research and Clinical Institute (MONIKI)

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-01-10

View on ClinicalTrials.gov More Children trials