Clinical trial NCT06706440: The Study of the Natural Way of Development of External Pancreatic Fistulas in Children with Necrotizing Pancreatitis
Official title: The Study of the Natural Way of Development of External Pancreatic Fistulas in Children with Necrotizing Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children
Pancreatic Fistula
Pancreatitis,Acute Necrotizing
Pancreatitis, Acute
Keywords: Children
Acute necrotizing pancreatitis
Pancreatic fistula
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
First posted: 2024-11-26
Enrollment: 26
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

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.

Eligibility criteria: 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

Primary outcomes:
measure: The duration of pancreatic fistula functioning
timeFrame: From the day of surgery to the end of treatment (9 months)
Secondary outcomes:
measure: The level of damage to the main pancreatic duct
timeFrame: From the day of surgery to the end of treatment (9 months)
measure: The duration of hospital stay
timeFrame: From the day of surgery to the end of treatment (9 months)
measure: The mortality
timeFrame: From enrollment to the end of treatment (9 month)
measure: The dynamics of the total protein
timeFrame: From enrollment to the end of treatment (9 month)
measure: The effect of the etiologic factor on the duration of the external pancreatic fistula functioning
timeFrame: From enrollment to the end of treatment (9 month)
measure: The dynamics of the drain tube fluid amylase
timeFrame: From enrollment to the end of treatment (9 month)
measure: The dynamics of the blood amylase
timeFrame: From enrollment to the end of treatment (9 month)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Study officials:
affiliation: Head of the Department of Pediatric Surgery
name: Dmitriy А Pyhteev, PhD
role: STUDY_DIRECTOR
affiliation: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
name: Leonid M Elin
role: PRINCIPAL_INVESTIGATOR
References: