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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Moscow, Russian Federation, 129110
- Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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Only data will be taken of patient's file.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The duration of pancreatic fistula functioning
Time Frame: From the day of surgery to the end of treatment (9 months)
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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
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From the day of surgery to the end of treatment (9 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The level of damage to the main pancreatic duct
Time Frame: From the day of surgery to the end of treatment (9 months)
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MRCP
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From the day of surgery to the end of treatment (9 months)
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The duration of hospital stay
Time Frame: From the day of surgery to the end of treatment (9 months)
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From the day of surgery to the end of treatment (9 months)
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The mortality
Time Frame: From enrollment to the end of treatment (9 month)
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From enrollment to the end of treatment (9 month)
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The dynamics of the total protein
Time Frame: From enrollment to the end of treatment (9 month)
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total protein (G/L)
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From enrollment to the end of treatment (9 month)
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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)
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number of days of functioning of the external pancreatic fistula depending on the etiological factor: trauma, ERCP, common bile duct stone, idiopathic, hypertriglyceridemia, alcohol
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From enrollment to the end of treatment (9 month)
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The dynamics of the drain tube fluid amylase
Time Frame: From enrollment to the end of treatment (9 month)
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drain tube fluid amylase (U/L)
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From enrollment to the end of treatment (9 month)
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The dynamics of the blood amylase
Time Frame: From enrollment to the end of treatment (9 month)
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blood amylase (U/L)
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From enrollment to the end of treatment (9 month)
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Collaborators and Investigators
Investigators
- Principal Investigator: Leonid M Elin, Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
- Study Director: Dmitriy А Pyhteev, PhD, Head of the Department of Pediatric Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/05.11.2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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