Pancreas DiseaseToPaGeNCT06466928
Total Pancreatectomies in Germany - Epidemiology, Trends,
An observational study of Pancreas Disease, run by Medizinische Hochschule Brandenburg Theodor Fontane.
Trial summary
The purpose of this study was to evaluate the real-world mortality rates of total pancreatectomy across Germany and to understand the impact of hospital caseload on surgical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Disease
- What is being tested?
- Total pancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 12,938 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 5 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population encompasses all patients that underwent total pancreatectomy in any German hospital (full survey of the German population).
Who may be able to join
- total pancreatectomy between January 2010 and December 2020
- 18 years or older
Who cannot join
- postmortem pancreatectomy (OPS code 5-525.4)
- removal of a pancreas transplant (OPS code 5-525.3)
About this study
Official title: A Nationwide Analysis of Total Pancreatectomy
The purpose of this study was to evaluate the real-world mortality rates of total pancreatectomy across Germany and to understand the impact of hospital caseload on surgical outcomes.
Read the detailed description
This retrospective observational study analyzed routine data from the nationwide German diagnosis-related group statistics, covering the years 2010 to 2020. The data included all inpatient episodes from acute care hospitals. The study focused on mortality rates associated with total pancreatectomy and examined how these rates varied with the complexity of the surgeries and the volume of procedures performed by different hospitals.
The mortality rates for total pancreatectomy in Germany were found to be more than three times higher than those reported by specialized pancreatic centers. Mortality rates increased significantly with the complexity of the total pancreatectomy procedures, especially those involving arterial resections. Hospitals with lower total pancreatectomy caseloads had higher mortality rates compared to high-volume centers.
Results showed that total pancreatectomies are associated with high mortality rates, particularly in hospitals with lower surgical volumes. The findings suggest that the promising outcomes from specialized centers cannot be generalized to all hospitals performing pancreatic surgeries, highlighting the need for a thorough understanding of the learning curve and specialization in pancreatic surgery to reduce mortality risks.
- Conditions
- Pancreas Disease
- Being tested
- Total pancreatectomy
- Keywords
- Specialization, Pancreatic Surgery, Total Resection, Volume-Outcome-Relationship
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total pancreatectomyProcedure or surgery
Surgical removal of the entire pancreas
| Study group | Role | What they receive |
|---|---|---|
| Standard Total pancreatectomy | Total pancreatectomy without vascular or adjacent organ resection. In cases with concomitant liver resection, only an excisional biopsy or wedge resection was to be performed Receives: Procedure: Total pancreatectomy | |
| Total pancreatectomy with venous resection | Total pancreatectomy with portal vein and/or superior mesenteric vein resection Receives: Procedure: Total pancreatectomy | |
| Total pancreatectomy with multivisceral resection | Total pancreatectomy with additional adjacent organ resection. The procedure extended beyond pylorus preserving, pylous resecting, and procedures with antrectomy and included the partial or total resection of additional organs with the exception of partial or total splenectomy. Procedures with liver resections, that required a larger atypical, segmental, bisegmental or major (hemihepatectomy) resection. Receives: Procedure: Total pancreatectomy | |
| Total pancreatectomy with arterial resection | Total pancreatectomy with arterial resection: superior mesenteric artery resections, hepatic artery resections, aortic resections, or resections of the celiac axis Receives: Procedure: Total pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death
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 posted20 Jun 2024
- Study start1 Jan 2010
- Primary completion31 Dec 2020
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas DiseaseStudies 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
- 12,938 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
- Sponsor type
- University, hospital or other
- Collaborators
- Margarete-Ammon-Stiftung
- Responsible party
- Principal investigator, Rene Mantke, Medizinische Hochschule Brandenburg Theodor Fontane
- Investigators
- Rene Mantke, MD, PhD, Study director, Head of Surgery at University Hospital Brandenburg an der Havel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466928
- Sponsor's protocol ID
- ToPaGe
- Acronym
- ToPaGe
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Data is held by the Federal Statistical Office of Germany. Individual participant data is not available for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Analysis of Total Pancreatectomy
- ClinicalTrials.gov ID
- NCT06466928
- Acronym / sponsor ID
- ToPaGe / ToPaGe
- Conditions
- Pancreas Disease
- Keywords
- Specialization, Pancreatic Surgery, Total Resection, Volume-Outcome-Relationship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,938 participants (actual)
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneUniversity, hospital or other
- Collaborators
- Margarete-Ammon-Stiftung
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 20 Jun 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 purpose of this study was to evaluate the real-world mortality rates of total pancreatectomy across Germany and to understand the impact of hospital caseload on surgical outcomes.
Detailed description
This retrospective observational study analyzed routine data from the nationwide German diagnosis-related group statistics, covering the years 2010 to 2020. The data included all inpatient episodes from acute care hospitals. The study focused on mortality rates associated with total pancreatectomy and examined how these rates varied with the complexity of the surgeries and the volume of procedures performed by different hospitals.
The mortality rates for total pancreatectomy in Germany were found to be more than three times higher than those reported by specialized pancreatic centers. Mortality rates increased significantly with the complexity of the total pancreatectomy procedures, especially those involving arterial resections. Hospitals with lower total pancreatectomy caseloads had higher mortality rates compared to high-volume centers.
Results showed that total pancreatectomies are associated with high mortality rates, particularly in hospitals with lower surgical volumes. The findings suggest that the promising outcomes from specialized centers cannot be generalized to all hospitals performing pancreatic surgeries, highlighting the need for a thorough understanding of the learning curve and specialization in pancreatic surgery to reduce mortality risks.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Total pancreatectomy | – | Procedure: Total pancreatectomyTotal pancreatectomy without vascular or adjacent organ resection. In cases with concomitant liver resection, only an excisional biopsy or wedge resection was to be performed |
| Total pancreatectomy with venous resection | – | Procedure: Total pancreatectomyTotal pancreatectomy with portal vein and/or superior mesenteric vein resection |
| Total pancreatectomy with multivisceral resection | – | Procedure: Total pancreatectomyTotal pancreatectomy with additional adjacent organ resection. The procedure extended beyond pylorus preserving, pylous resecting, and procedures with antrectomy and included the partial or total resection of additional organs with the exception of partial or total splenectomy. Procedures with liver resections, that required a larger atypical, segmental, bisegmental or major (hemihepatectomy) resection. |
| Total pancreatectomy with arterial resection | – | Procedure: Total pancreatectomyTotal pancreatectomy with arterial resection: superior mesenteric artery resections, hepatic artery resections, aortic resections, or resections of the celiac axis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population encompasses all patients that underwent total pancreatectomy in any German hospital (full survey of the German population).
Key inclusion criteria (2 listed)
- total pancreatectomy between January 2010 and December 2020
- 18 years or older
Key exclusion criteria (2 listed)
- postmortem pancreatectomy (OPS code 5-525.4)
- removal of a pancreas transplant (OPS code 5-525.3)
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 |
|---|---|---|
| Total pancreatectomySurgical removal of the entire pancreas | Procedure or surgery | Standard Total pancreatectomy, Total pancreatectomy with arterial resection, Total pancreatectomy with multivisceral resection, Total pancreatectomy with venous resection |
Primary outcome
In-hospital mortality
Time frame: 30 days
Death
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 Jun 2024.
- Individual participant dataSharing planned: No. No Data is held by the Federal Statistical Office of Germany. Individual participant data is not available for data sharing.
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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.
Rene Mantke, MD, PhD study director
Head of Surgery at University Hospital Brandenburg an der Havel
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Disease, 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 20 Jun 2024. 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?
In-hospital mortality (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 20 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.