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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention, observational study | Other | Only data will be taken of patient's file. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the day of surgery to the end of treatment (9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| The level of damage to the main pancreatic duct | MRCP | From the day of surgery to the end of treatment (9 months) |
| The duration of hospital stay | From the day of surgery to the end of treatment (9 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
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| Name | Affiliation | Role |
|---|---|---|
| Dmitriy А Pyhteev, PhD | Head of the Department of Pediatric Surgery | Study Director |
| Leonid M Elin | Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky | Moscow | 129110 | Russia |
A complete dataset can be provided upon reasoned request
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| The mortality | From enrollment to the end of treatment (9 month) |
| The dynamics of the total protein | total protein (G/L) | 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 | From enrollment to the end of treatment (9 month) |
| The dynamics of the drain tube fluid amylase | drain tube fluid amylase (U/L) | From enrollment to the end of treatment (9 month) |
| The dynamics of the blood amylase | blood amylase (U/L) | From enrollment to the end of treatment (9 month) |
| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| D019283 | Pancreatitis, Acute Necrotizing |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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