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NCT Number: NCT06706440

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

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.

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Key information

Conditions

Children Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pancreatic Fistula Pancreatitis Pancreatitis, Acute Pancreatitis, Acute Necrotizing Pancreatitis,Acute Necrotizing Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Moscow, 129110, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention, observational study

Other

Only data will be taken of patient's file.

Primary outcomes

  1. The duration of pancreatic fistula functioning

    Time frame: From 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 outcomes

  1. The level of damage to the main pancreatic duct

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

    MRCP

  2. The duration of hospital stay

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

  3. The mortality

    Time frame: From enrollment to the end of treatment (9 month)

  4. The dynamics of the total protein

    Time frame: From enrollment to the end of treatment (9 month)

    total protein (G/L)

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

    Time frame: From 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

  6. The dynamics of the drain tube fluid amylase

    Time frame: From enrollment to the end of treatment (9 month)

    drain tube fluid amylase (U/L)

  7. The dynamics of the blood amylase

    Time frame: From enrollment to the end of treatment (9 month)

    blood amylase (U/L)

Sponsors and collaborators

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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