PancreatitisNCT06700330
Etiology, Clinical Picture, Complications and Outcomes of Necrotizing Pancreatitis in Children.
An observational study of Pancreatitis and Pancreatitis, Acute Necrotizing, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
Trial summary
The aim of this research is to study the etiology, the clinical picture, the management, the complications and the outcomes of necrotic pancreatitis in children. Currently, there is a significant number of errors in the early diagnosis of AP in children associated with the complexity of differential diagnosis, which… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pancreatitis, Pancreatitis, Acute Necrotizing, Children
- How many people
- 102 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 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
- Consent of the patient or legal representative
- Age from 0-18 years
- Moderate severe (MSAP) or severe acute pancreatitis (SAP) according to Atlanta criteria revisited in 2012
- Acute Pancreatitis was established in the presence of at least two of three criteria according to the classification developed by the INSPPIRE group (International Study Group of Pediatric Pancreatitis: In Search for a Cure): abdominal pain corresponding to the diagnostic hypothesis; an increase in amylase and / or lipase in the blood serum by ≥3 times; imaging findings characteristic 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, Moscow Oblast, 129110
About this study
Official title: Study of the Etiology, Clinical Picture, Complications and Outcomes of Necrotizing Pancreatitis in Children.
The aim of this research is to study the etiology, the clinical picture, the management, the complications and the outcomes of necrotic pancreatitis in children.
Currently, there is a significant number of errors in the early diagnosis of AP in children associated with the complexity of differential diagnosis, which leads to the untimely verification of the correct diagnosis and, consequently, to incorrect treatment tactics, which could be accompanied by an increase in the severe forms of the disease and an increase in mortality.
Read the detailed description
Acute pancreatitis (AP) is an acute inflammatory disease of the exocrine pancreas. Clinical manifestations vary from mild abdominal discomfort to metabolic disorders, sepsis, fluid sequestration, multiple organ failure and death. According to the international data, the annual incidence of AP in children is 3-13 cases per 100,000 people, but in recent years, there has been an increase in the incidence of this pathology. Necrotic pancreatitis in children accounts for up to 25-30% of the cases of all forms of AP. Despite the successes achieved in the diagnosis and treatment of AP, the mortality rate for this pathology is up to 5%, according to various authors. In addition, given the varying degrees of the prevalence of the destructive process in the pancreas and the parapancreatic tissue, the choice of surgical treatment still remains a subject of discussion. The treatment of moderately severe (MSAP) and severe (SAP) necrotic pancreatitis is a complex task due to the variety of causes of the disease, the incompletely understood pathogenesis and the uncertainty in predicting the results.
Paralytic ileus with the development of intestinal failure is the main pathogenetic factor in the development of a septic condition in AP, but there is tendency of insufficient attention being paid to this fact in pediatric practice, which determines the lack of a unified approach to the treatment of intestinal failure syndrome.
- Conditions
- Pancreatitis, Pancreatitis, Acute Necrotizing, Children
- Being tested
- no intervention, observational study
- Keywords
- Pancreatitis, Acute Necrotizing Pancreatitis, Children
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing
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 from the patient file.
| Study group | Role | What they receive |
|---|---|---|
| Children with necrotizing pancreatitis | children who have suffered acute pacreatitis Receives: Other: no intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of occurrence of various etiologic causes of necrotizing pancreatitis in children
based on the study, the most common causes of necrotizing pancreatitis in children will be identified
Measured: From enrollment to the end of treatment (2 month)
Secondary outcomes (11)
The duration from the onset of the disease to the start of the treatment
Measured: from the onset of the disease to the end of treatment (up to 20 weeks)
The duration of hospital stay
the effect of each risk factor on the duration of hospital stay
Measured: from admission to hospital until the end of treatment (up to 8 weeks)
The length of ICU stay
Measured: During ICU stay (up to 60 days)
The effect of comorbidities on the severity of the disease
Measured: from admission to hospital until the end of treatment (up to 8 weeks)
Intestinal failure
the effect of Intestinal failure on the duration of hospital stay
Measured: from admission to hospital until the end of treatment (up to 8 weeks)
Paralytic ileus
the effect of paralytic ileus on the severity of acute pancreatitis and the length of hospital stay
Measured: from admission to hospital until the end of treatment (up to 8 weeks)
Mortality
Measured: from admission to hospital until the end of treatment (up to 20 weeks)
Enzymatic parapancreatitis
the effect on severity of the disease and the outcome
Measured: from admission to hospital until the end of treatment (up to 10 weeks)
Purulent-necrotic parapancreatitis
the effect on severity of the disease and the outcome
Measured: from admission to hospital until the end of treatment (up to 20 weeks)
Biliary obstruction
Measured: from admission to hospital until the end of treatment (up to 20 weeks)
Surgical interventions
Measured: from admission to hospital until the end of treatment (up to 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Dec 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 PancreatitisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dmitriy A 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
- NCT06700330
- Sponsor's protocol ID
- 16/01.11.2024
- 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
- Study of the Etiology, Clinical Picture, Complications and Outcomes of Necrotizing Pancreatitis in Children.
- ClinicalTrials.gov ID
- NCT06700330
- Acronym / sponsor ID
- 16/01.11.2024
- Conditions
- Pancreatitis, Pancreatitis, Acute Necrotizing, Children
- Keywords
- Pancreatitis, Acute Necrotizing Pancreatitis, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 21 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 aim of this research is to study the etiology, the clinical picture, the management, the complications and the outcomes of necrotic pancreatitis in children.
Currently, there is a significant number of errors in the early diagnosis of AP in children associated with the complexity of differential diagnosis, which leads to the untimely verification of the correct diagnosis and, consequently, to incorrect treatment tactics, which could be accompanied by an increase in the severe forms of the disease and an increase in mortality.
Detailed description
Acute pancreatitis (AP) is an acute inflammatory disease of the exocrine pancreas. Clinical manifestations vary from mild abdominal discomfort to metabolic disorders, sepsis, fluid sequestration, multiple organ failure and death. According to the international data, the annual incidence of AP in children is 3-13 cases per 100,000 people, but in recent years, there has been an increase in the incidence of this pathology. Necrotic pancreatitis in children accounts for up to 25-30% of the cases of all forms of AP. Despite the successes achieved in the diagnosis and treatment of AP, the mortality rate for this pathology is up to 5%, according to various authors. In addition, given the varying degrees of the prevalence of the destructive process in the pancreas and the parapancreatic tissue, the choice of surgical treatment still remains a subject of discussion. The treatment of moderately severe (MSAP) and severe (SAP) necrotic pancreatitis is a complex task due to the variety of causes of the disease, the incompletely understood pathogenesis and the uncertainty in predicting the results.
Paralytic ileus with the development of intestinal failure is the main pathogenetic factor in the development of a septic condition in AP, but there is tendency of insufficient attention being paid to this fact in pediatric practice, which determines the lack of a unified approach to the treatment of intestinal failure syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with necrotizing pancreatitis | – | Other: no intervention, observational studychildren who have suffered acute pacreatitis |
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 (4 listed)
- Consent of the patient or legal representative
- Age from 0-18 years
- Moderate severe (MSAP) or severe acute pancreatitis (SAP) according to Atlanta criteria revisited in 2012
- Acute Pancreatitis was established in the presence of at least two of three criteria according to the classification developed by the INSPPIRE group (International Study Group of Pediatric Pancreatitis: In Search for a Cure): abdominal pain corresponding to the diagnostic hypothesis; an increase in amylase and / or lipase in the blood serum by ≥3 times; imaging findings characteristic 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 from the patient file. | Other | Children with necrotizing pancreatitis |
Primary outcome
the frequency of occurrence of various etiologic causes of necrotizing pancreatitis in children
Time frame: From enrollment to the end of treatment (2 month)
based on the study, the most common causes of necrotizing pancreatitis in children will be identified
11 secondary outcomes
The duration from the onset of the disease to the start of the treatment
Time frame: from the onset of the disease to the end of treatment (up to 20 weeks)
The duration of hospital stay
Time frame: from admission to hospital until the end of treatment (up to 8 weeks)
The length of ICU stay
Time frame: During ICU stay (up to 60 days)
The effect of comorbidities on the severity of the disease
Time frame: from admission to hospital until the end of treatment (up to 8 weeks)
Intestinal failure
Time frame: from admission to hospital until the end of treatment (up to 8 weeks)
Paralytic ileus
Time frame: from admission to hospital until the end of treatment (up to 8 weeks)
Mortality
Time frame: from admission to hospital until the end of treatment (up to 20 weeks)
Enzymatic parapancreatitis
Time frame: from admission to hospital until the end of treatment (up to 10 weeks)
Purulent-necrotic parapancreatitis
Time frame: from admission to hospital until the end of treatment (up to 20 weeks)
Biliary obstruction
Time frame: from admission to hospital until the end of treatment (up to 20 weeks)
Surgical interventions
Time frame: from admission to hospital until the end of treatment (up to 20 weeks)
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 A 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 Pancreatitis and Pancreatitis, Acute Necrotizing, 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 4 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 frequency of occurrence of various etiologic causes of necrotizing pancreatitis in children (time frame: From enrollment to the end of treatment (2 month)). 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.