ChildrenNCT06706440
The Study of the Natural Way of Development of External Pancreatic Fistulas in Children with Necrotizing Pancreatitis
An observational study of Children and Pancreatic Fistula, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Children, Pancreatic Fistula, Pancreatitis,Acute Necrotizing
- How many people
- 26 participants
- Where
- 1 siteRussia
- Study dates
- 11 Nov 2024to 18 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Who may be able to join
- 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.
Who cannot join
- Mild acute pancreatitis
- Chronic pancreatitis
- No consent from patient or legal representative
Trial locations and contacts
1 site in 1 country.
Russia1 site
Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Moscow, 129110
About this study
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.
Read the 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.
- Being tested
- no intervention, observational study
- Keywords
- Children, Acute necrotizing pancreatitis, Pancreatic fistula
- Medical subject headings
- Pancreatic Fistula, Pancreatitis, Acute Necrotizing, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, observational studyOther
Only data will be taken of patient's file.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: no intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the day of surgery to the end of treatment (9 months)
Secondary outcomes (7)
The level of damage to the main pancreatic duct
MRCP
Measured: From the day of surgery to the end of treatment (9 months)
The duration of hospital stay
Measured: From the day of surgery to the end of treatment (9 months)
The mortality
Measured: From enrollment to the end of treatment (9 month)
The dynamics of the total protein
total protein (G/L)
Measured: 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
Measured: From enrollment to the end of treatment (9 month)
The dynamics of the drain tube fluid amylase
drain tube fluid amylase (U/L)
Measured: From enrollment to the end of treatment (9 month)
The dynamics of the blood amylase
blood amylase (U/L)
Measured: From enrollment to the end of treatment (9 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start11 Nov 2024
- Primary completion10 Jan 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dmitriy А Pyhteev, PhD, Study director, Head of the Department of Pediatric SurgeryLeonid M Elin, Principal investigator, Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706440
- Sponsor's protocol ID
- 16/05.11.2024
- Status last verified
- Feb 2025
- First submitted
- 20 Nov 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A complete dataset can be provided upon reasoned request
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of the Natural Way of Development of External Pancreatic Fistulas in Children with Necrotizing Pancreatitis
- ClinicalTrials.gov ID
- NCT06706440
- Acronym / sponsor ID
- 16/05.11.2024
- Keywords
- Children, Acute necrotizing pancreatitis, Pancreatic fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with external pancreatic fistula | – | Other: no intervention, observational studychildren who have suffered acute necrotizing pacreatitis and undergone drainage of parapancreatic accumulations, with the development of an external pancreatic fistula |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Mild acute pancreatitis
- Chronic pancreatitis
- No consent from patient or legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, observational studyOnly data will be taken of patient's file. | Other | children with external pancreatic fistula |
Primary outcome
The duration of pancreatic fistula functioning
Time frame: From the day of surgery to the end of treatment (9 months)
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
7 secondary outcomes
The level of damage to the main pancreatic duct
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
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
Time frame: From enrollment to the end of treatment (9 month)
The dynamics of the drain tube fluid amylase
Time frame: From enrollment to the end of treatment (9 month)
The dynamics of the blood amylase
Time frame: From enrollment to the end of treatment (9 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Yes. A complete dataset can be provided upon reasoned request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitriy А Pyhteev, PhD study director
Head of the Department of Pediatric Surgery
Leonid M Elin principal investigator
Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children and Pancreatic Fistula, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of pancreatic fistula functioning (time frame: From the day of surgery to the end of treatment (9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.