Pancreatic SurgeryChiPSNCT07293104
Children in Pancreatic Surgery: Indications, Procedures and Outcomes
An observational study of Pancreatic Surgery and Children, run by Medizinische Hochschule Brandenburg Theodor Fontane.
Trial summary
Pediatric patients differ in a variety of properties from adult populations, but comprehensive multicenter or population-based data is missing for pancreatic surgery. This study aimed to evaluate indications, complications, and mortality in pediatric pancreatic surgery. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pancreatic Surgery, Children
- What is being tested?
- Pancreatoduodenectomy, Total pancreatectomy and Distal pancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 761 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2023
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All persons addmitted to a German hospital between 2010 and 2023. Population-based dataset.
Who may be able to join
- stationary hospital admission
- pancreatic surgical procedure
Who cannot join
- unknown sex or age
- admission for pancreas tranplantation
About this study
Official title: Children in Pancreatic Surgery
Pediatric patients differ in a variety of properties from adult populations, but comprehensive multicenter or population-based data is missing for pancreatic surgery. This study aimed to evaluate indications, complications, and mortality in pediatric pancreatic surgery.
Read the detailed description
This retrospective observational population-based cohort study analzes the German Diagnostic-Related Group database and included all children with pancreatic procedures between 2010 and 2023. The primary outcomes are mortality rates, complication rates, and sex differences related to surgical indication and pancreatic procedure. Descriptive epidemiological and multivariable regression analyses are performed to identify risk factors of mortality and occurrence of perioperative complications.
- Conditions
- Pancreatic Surgery, Children
- Being tested
- Pancreatoduodenectomy, Total pancreatectomy, Distal pancreatectomy, Anastomosis of the pancreatic duct, Incision of the pancreas
- Keywords
- Chidren, Pancreatic surgery, Surgical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreatoduodenectomyProcedure or surgery
Procedure codes: 5-524.1; 5-524.2; 5-524.3
Total pancreatectomyProcedure or surgery
Procedure codes: 5-525.*
Distal pancreatectomyProcedure or surgery
Procedure code: 5-524.0
Anastomosis of the pancreatic ductProcedure or surgery
Procedure codes: 5-527.*
Incision of the pancreasProcedure or surgery
Procedure codes: 5-520.*
Internal drainage of the pancreasProcedure or surgery
Procedure codes: 5-523.*
Local excision destruction pancreasProcedure or surgery
Procedure codes: 5-521.*
Marsupialization of a pancreatic cystProcedure or surgery
Procedure codes: 5-522.*
Segmental pancreatic resectionProcedure or surgery
Procedure codes: 5-524.0*; 5-524-x; 5-524.y
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic tumor | Not described Receives: Procedure: Pancreatoduodenectomy; Procedure: Total pancreatectomy; Procedure: Distal pancreatectomy; Procedure: Anastomosis of the pancreatic duct; Procedure: Incision of the pancreas; Procedure: Internal drainage of the pancreas; Procedure: Local excision destruction pancreas; Procedure: Marsupialization of a pancreatic cyst; Procedure: Segmental pancreatic resection | |
| Chronic pancreatitis | Not described Receives: Procedure: Pancreatoduodenectomy; Procedure: Total pancreatectomy; Procedure: Distal pancreatectomy; Procedure: Anastomosis of the pancreatic duct; Procedure: Incision of the pancreas; Procedure: Internal drainage of the pancreas; Procedure: Local excision destruction pancreas; Procedure: Marsupialization of a pancreatic cyst; Procedure: Segmental pancreatic resection | |
| Trauma | Not described Receives: Procedure: Pancreatoduodenectomy; Procedure: Total pancreatectomy; Procedure: Distal pancreatectomy; Procedure: Anastomosis of the pancreatic duct; Procedure: Incision of the pancreas; Procedure: Internal drainage of the pancreas; Procedure: Local excision destruction pancreas; Procedure: Marsupialization of a pancreatic cyst; Procedure: Segmental pancreatic resection | |
| Extra-pancreatic neoplasm | Not described Receives: Procedure: Pancreatoduodenectomy; Procedure: Total pancreatectomy; Procedure: Distal pancreatectomy; Procedure: Anastomosis of the pancreatic duct; Procedure: Incision of the pancreas; Procedure: Internal drainage of the pancreas; Procedure: Local excision destruction pancreas; Procedure: Marsupialization of a pancreatic cyst; Procedure: Segmental pancreatic resection | |
| Other diseases | Not described Receives: Procedure: Pancreatoduodenectomy; Procedure: Total pancreatectomy; Procedure: Distal pancreatectomy; Procedure: Anastomosis of the pancreatic duct; Procedure: Incision of the pancreas; Procedure: Internal drainage of the pancreas; Procedure: Local excision destruction pancreas; Procedure: Marsupialization of a pancreatic cyst; Procedure: Segmental pancreatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Perioperative death
Measured: 30 days
Secondary outcomes (1)
Complication rates
Perioperative surgical-related complication
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic SurgeryStudies 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
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Hunger, Medizinische Hochschule Brandenburg Theodor Fontane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293104
- Sponsor's protocol ID
- ChiPS
- Acronym
- ChiPS
- Status last verified
- Oct 2025
- First submitted
- 5 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is held and provided by the Federal Statistical Office of Germany and the statistical offices of the federal states. Due to data privacy regulations, data sharing is strictly prohibited by German law. Furthermore, the data was evaluated exclusively within the framework of controlled remote data analysis. This meant that we never had direct access to the raw data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children in Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT07293104
- Acronym / sponsor ID
- ChiPS / ChiPS
- Conditions
- Pancreatic Surgery, Children
- Keywords
- Chidren, Pancreatic surgery, Surgical outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Dec 2025 (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.
Pediatric patients differ in a variety of properties from adult populations, but comprehensive multicenter or population-based data is missing for pancreatic surgery. This study aimed to evaluate indications, complications, and mortality in pediatric pancreatic surgery.
Detailed description
This retrospective observational population-based cohort study analzes the German Diagnostic-Related Group database and included all children with pancreatic procedures between 2010 and 2023. The primary outcomes are mortality rates, complication rates, and sex differences related to surgical indication and pancreatic procedure. Descriptive epidemiological and multivariable regression analyses are performed to identify risk factors of mortality and occurrence of perioperative complications.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pancreatic tumor | – | Procedure: Pancreatoduodenectomy, Procedure: Total pancreatectomy, Procedure: Distal pancreatectomy, Procedure: Anastomosis of the pancreatic duct, Procedure: Incision of the pancreas, Procedure: Internal drainage of the pancreas, Procedure: Local excision destruction pancreas, Procedure: Marsupialization of a pancreatic cyst, Procedure: Segmental pancreatic resection |
| Chronic pancreatitis | – | Procedure: Pancreatoduodenectomy, Procedure: Total pancreatectomy, Procedure: Distal pancreatectomy, Procedure: Anastomosis of the pancreatic duct, Procedure: Incision of the pancreas, Procedure: Internal drainage of the pancreas, Procedure: Local excision destruction pancreas, Procedure: Marsupialization of a pancreatic cyst, Procedure: Segmental pancreatic resection |
| Trauma | – | Procedure: Pancreatoduodenectomy, Procedure: Total pancreatectomy, Procedure: Distal pancreatectomy, Procedure: Anastomosis of the pancreatic duct, Procedure: Incision of the pancreas, Procedure: Internal drainage of the pancreas, Procedure: Local excision destruction pancreas, Procedure: Marsupialization of a pancreatic cyst, Procedure: Segmental pancreatic resection |
| Extra-pancreatic neoplasm | – | Procedure: Pancreatoduodenectomy, Procedure: Total pancreatectomy, Procedure: Distal pancreatectomy, Procedure: Anastomosis of the pancreatic duct, Procedure: Incision of the pancreas, Procedure: Internal drainage of the pancreas, Procedure: Local excision destruction pancreas, Procedure: Marsupialization of a pancreatic cyst, Procedure: Segmental pancreatic resection |
| Other diseases | – | Procedure: Pancreatoduodenectomy, Procedure: Total pancreatectomy, Procedure: Distal pancreatectomy, Procedure: Anastomosis of the pancreatic duct, Procedure: Incision of the pancreas, Procedure: Internal drainage of the pancreas, Procedure: Local excision destruction pancreas, Procedure: Marsupialization of a pancreatic cyst, Procedure: Segmental pancreatic resection |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All persons addmitted to a German hospital between 2010 and 2023. Population-based dataset.
Key inclusion criteria (2 listed)
- stationary hospital admission
- pancreatic surgical procedure
Key exclusion criteria (2 listed)
- unknown sex or age
- admission for pancreas tranplantation
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 |
|---|---|---|
| PancreatoduodenectomyProcedure codes: 5-524.1; 5-524.2; 5-524.3 | Procedure or surgery | Chronic pancreatitis, Extra-pancreatic neoplasm, Other diseases, Pancreatic tumor, Trauma |
| Total pancreatectomyProcedure codes: 5-525.* | Procedure or surgery | Chronic pancreatitis, Extra-pancreatic neoplasm, Other diseases, Pancreatic tumor, Trauma |
| Distal pancreatectomyProcedure code: 5-524.0 | Procedure or surgery | Chronic pancreatitis, Extra-pancreatic neoplasm, Other diseases, Pancreatic tumor, Trauma |
| Anastomosis of the pancreatic ductProcedure codes: 5-527.* | Procedure or surgery | Chronic pancreatitis, Extra-pancreatic neoplasm, Other diseases, Pancreatic tumor, Trauma |
| Incision of the pancreasProcedure codes: 5-520.* | Procedure or surgery | Chronic pancreatitis, Extra-pancreatic neoplasm, Other diseases, Pancreatic tumor, Trauma |
| Internal drainage of the pancreasProcedure codes: 5-523.* | Procedure or surgery | Chronic pancreatitis, Extra-pancreatic neoplasm, Other diseases, Pancreatic tumor, Trauma |
| Local excision destruction pancreasProcedure codes: 5-521.* | Procedure or surgery | Chronic pancreatitis, Extra-pancreatic neoplasm, Other diseases, Pancreatic tumor, Trauma |
| Marsupialization of a pancreatic cystProcedure codes: 5-522.* | Procedure or surgery | Chronic pancreatitis, Extra-pancreatic neoplasm, Other diseases, Pancreatic tumor, Trauma |
| Segmental pancreatic resectionProcedure codes: 5-524.0*; 5-524-x; 5-524.y | Procedure or surgery | Chronic pancreatitis, Extra-pancreatic neoplasm, Other diseases, Pancreatic tumor, Trauma |
Primary outcome
Mortality rate
Time frame: 30 days
Perioperative death
1 secondary outcome
Complication rates
Time frame: 30 days
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 24 Dec 2025.
- Individual participant dataSharing planned: No. The data is held and provided by the Federal Statistical Office of Germany and the statistical offices of the federal states. Due to data privacy regulations, data sharing is strictly prohibited by German law. Furthermore, the data was evaluated exclusively within the framework of controlled remote data analysis. This meant that we never had direct access to the raw data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Surgery and Children, run by Medizinische Hochschule Brandenburg Theodor Fontane.
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 2 inclusion and 2 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality rate (time frame: 30 days). 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 24 Dec 2025.