An observational study in Children, Pancreatic Fistula and Pancreatitis,Acute Necrotizing, sponsored by Moscow Regional Research and Clinical Institute (MONIKI). Completed at 1 site in Russian Federation. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Moscow Regional Research and Clinical Institute (MONIKI) · Observational
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.
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.
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's enrollment of 26 is below the median of 180 across 277 observational studies indexed under Pancreatitis.
Browse Pancreatitis studies →Moscow Regional Research and Clinical Institute (MONIKI) is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Exclusion Criteria:
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
Only data will be taken of patient's file.
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
Time frame: From the day of surgery to the end of treatment (9 months)
The level of damage to the main pancreatic duct
MRCP
Time frame: From the day of surgery to the end of treatment (9 months)
The duration of hospital stay
Time frame: From the day of surgery to the end of treatment (9 months)
The mortality
Time frame: From enrollment to the end of treatment (9 month)
The dynamics of the total protein
total protein (G/L)
Time frame: From enrollment to the end of treatment (9 month)
The effect of the etiologic factor on the duration of the external pancreatic fistula functioning
number of days of functioning of the external pancreatic fistula depending on the etiological factor: trauma, ERCP, common bile duct stone, idiopathic, hypertriglyceridemia, alcohol
Time frame: From enrollment to the end of treatment (9 month)
The dynamics of the drain tube fluid amylase
drain tube fluid amylase (U/L)
Time frame: From enrollment to the end of treatment (9 month)
The dynamics of the blood amylase
blood amylase (U/L)
Time frame: From enrollment to the end of treatment (9 month)
Plan to share: Yes — A complete dataset can be provided upon reasoned request
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Moscow Regional Research and Clinical Institute (MONIKI)