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

Moscow Regional Research and Clinical Institute (MONIKI)

Status: Completed

Conditions: Pancreatic Fistula; Pancreatitis,Acute Necrotizing; Pancreatitis, Acute; Children

Treatments: Other: no intervention, observational study

Study type: Observational

Funder types: Other

Identifiers

NCT06706440

16/05.11.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

26 participants in 1 patient group

children with external pancreatic fistula

Description:

children who have suffered acute necrotizing pacreatitis and undergone drainage of parapancreatic accumulations, with the development of an external pancreatic fistula

Treatment:

Other: no intervention, observational study