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: Completed
• Conditions: Children; Pancreatic Fistula; Pancreatitis, Acute; Pancreatitis,Acute Necrotizing
• Intervention / Treatment: Other: no intervention, observational study

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: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 129110
    • Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: no intervention, observational study; Only data will be taken of patient's file.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
• 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): November 11, 2024
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): February 18, 2025

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Children; Pancreatic fistula; Acute necrotizing pancreatitis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Pancreatic Diseases; Digestive System Fistula; Pancreatitis; Fistula; Pancreatic Fistula; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: 16/05.11.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A complete dataset can be provided upon reasoned request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No