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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06706440
Enrollment
26
Registered
2024-11-26
Start date
2024-11-11
Completion date
2025-02-18
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Children, Acute necrotizing pancreatitis, Pancreatic fistula

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.

Detailed description

The treatment of EPF has traditionally been conservative, including the nutritional support in an attempt to reduce pancreatic secretion, or total parenteral nutrition with antisecretory therapy (octreotide). In cases where the conservative therapy has proved to be ineffective, there has been performed the surgical treatment. The cases of successful treatment of EPF by endoscopic transpapillary drainage have been reported in the literature as an effective and minimally invasive therapeutic alternative to the surgery for the treatment of EPF. However, the endoscopic transpapillary drainage is usually ineffective in patients with the complete PD failure. The complete PD failure in the presence of the functional pancreas above the failure results in the disconnected pancreatic duct syndrome. Sepsis, infection, electrolyte disturbances, malnutrition, and infections are commonly seen in patients with high-output EPF. In addition, there has occasionally been reported the spontaneous closure of low-output EPF. However, there are no data on the natural history of EPF. The aim of this study is to evaluate the natural clinical history of EPF in children with necrotizing pancreatitis by examining the outcomes and the complications of the conservative treatment.

Interventions

Only data will be taken of patient's file.

Sponsors

Moscow Regional Research and Clinical Institute (MONIKI)
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The duration of pancreatic fistula functioningFrom the day of surgery to the end of treatment (9 months)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

Secondary

MeasureTime frameDescription
The level of damage to the main pancreatic ductFrom the day of surgery to the end of treatment (9 months)MRCP
The duration of hospital stayFrom the day of surgery to the end of treatment (9 months)
The mortalityFrom enrollment to the end of treatment (9 month)
The dynamics of the total proteinFrom enrollment to the end of treatment (9 month)total protein (G/L)
The dynamics of the drain tube fluid amylaseFrom enrollment to the end of treatment (9 month)drain tube fluid amylase (U/L)
The dynamics of the blood amylaseFrom enrollment to the end of treatment (9 month)blood amylase (U/L)
The effect of the etiologic factor on the duration of the external pancreatic fistula functioningFrom enrollment to the end of treatment (9 month)number of days of functioning of the external pancreatic fistula depending on the etiological factor: trauma, ERCP, common bile duct stone, idiopathic, hypertriglyceridemia, alcohol

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026