Pancreas DiseasePatSelPancNCT06390891
Role of Patient Selection for Pancreatic Resections
An observational study of Pancreas Disease, run by Medizinische Hochschule Brandenburg Theodor Fontane.
Trial summary
Pancreatic surgery is complicated and risky, especially for pancreatic cancer. It's been noticed that having these surgeries done at specialized centers can lead to better outcomes and survival rates. However, factors like patient selection and hospital conditions also play an important role. 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?
- Persons with pancreatic resection in a hospital with at least 50 pancreatic resections annually (observational), and Persons with pancreatic resection in a hospital not performing at least 50 pancreatic resections annually (observational),
- How many people
- 86,073 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2018
- 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
- Adult, Older adult
Study population: The study population encompasses all patients that underwent any pancreatic resection procedure in any German hospital (full survey of the German population).
Who may be able to join
- partial or total pancreatic resections between 2010 and 2018
Who cannot join
- childhood (<18 years)
- subjects with a pancreatic transplantation procedure
- missing information on age or gender
About this study
Official title: Importance of Patient Characteristics in Identifying and Selecting Patients Suitable for Pancreatic Resection
Pancreatic surgery is complicated and risky, especially for pancreatic cancer. It's been noticed that having these surgeries done at specialized centers can lead to better outcomes and survival rates. However, factors like patient selection and hospital conditions also play an important role. Some studies show that more surgeries done at a hospital might not always mean better results, as the type of patients and procedures can vary. To understand this better, the present study compared outcomes and patient characteristics between high-volume pancreatic centers and others.
Read the detailed description
The study utilized German nationwide administrative data (diagnosis-related group statistics) spanning from 2010 to 2018. Persons who underwent pancreatic resections during this period were included, with exclusions for certain criteria like underage and type of procedure. Various factors including patient demographics, diagnoses, procedures, and comorbidities were analyzed to assess in-hospital mortality rates. High-volume pancreatic centers (HVPCs) were identified as those performing at least 50 procedures annually. Statistical analyses included comparing crude and adjusted mortality rates and assessing patient characteristics between HVPCs and non-HVPCs. Models were adjusted for multiple variables, and methods like the Cochran-Armitage trend test and mixed models were employed. Additionally, the study investigated how differences in patient characteristics between HVPCs and non-HVPCs affected mortality rates.
- Conditions
- Pancreas Disease
- Being tested
- Persons with pancreatic resection in a hospital with at least 50 pancreatic resections annually (observational),, Persons with pancreatic resection in a hospital not performing at least 50 pancreatic resections annually (observational),
- Keywords
- Specialization, Pancreatic Surgery, 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.
Persons with pancreatic resection in a hospital with at least 50 pancreatic resections annually (observational),Other
Persons that have undergone a pancreatic resection at a hospital with at least 50 pancreatic resections annually (observational)
Persons with pancreatic resection in a hospital not performing at least 50 pancreatic resections annually (observational),Other
Persons that have undergone a pancreatic resection at a hospital with not at least 50 pancreatic resections annually (observational)
| Study group | Role | What they receive |
|---|---|---|
| Patients treated in high-volume pancreatic centers | Patients treated at a hospital performing at least 50 pancreatic resection procedures annually during 2010 to 2018 Receives: Other: Persons with pancreatic resection in a hospital with at least 50 pancreatic resections annually (observational), | |
| Patients treated in low-volume pancreatic centers | Patients not treated at a hospital performing at least 50 pancreatic resection procedures annually during 2010 to 2018 Receives: Other: Persons with pancreatic resection in a hospital not performing at least 50 pancreatic resections annually (observational), |
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 posted30 Apr 2024
- Study start1 Jan 2010
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 86,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
- Sponsor type
- University, hospital or other
- 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
- NCT06390891
- Sponsor's protocol ID
- PatSelPanc
- Acronym
- PatSelPanc
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not available for data sharing.
Publications
Mantke R, Seliger B, Ogino S, Buchler MW, Hunger R. Not Only Caseload but Also Patient Selection Is Predictive of Mortality After Pancreatic Resection. Ann Surg Open. 2024 Dec 30;6(1):e536. doi: 10.1097/AS9.0000000000000536. eCollection 2025 Mar.
PubMed 40134472
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Patient Characteristics in Identifying and Selecting Patients Suitable for Pancreatic Resection
- ClinicalTrials.gov ID
- NCT06390891
- Acronym / sponsor ID
- PatSelPanc / PatSelPanc
- Conditions
- Pancreas Disease
- Keywords
- Specialization, Pancreatic Surgery, Resection, Volume-Outcome-Relationship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86,073 participants (actual)
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Apr 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.
Pancreatic surgery is complicated and risky, especially for pancreatic cancer. It's been noticed that having these surgeries done at specialized centers can lead to better outcomes and survival rates. However, factors like patient selection and hospital conditions also play an important role. Some studies show that more surgeries done at a hospital might not always mean better results, as the type of patients and procedures can vary. To understand this better, the present study compared outcomes and patient characteristics between high-volume pancreatic centers and others.
Detailed description
The study utilized German nationwide administrative data (diagnosis-related group statistics) spanning from 2010 to 2018. Persons who underwent pancreatic resections during this period were included, with exclusions for certain criteria like underage and type of procedure. Various factors including patient demographics, diagnoses, procedures, and comorbidities were analyzed to assess in-hospital mortality rates. High-volume pancreatic centers (HVPCs) were identified as those performing at least 50 procedures annually. Statistical analyses included comparing crude and adjusted mortality rates and assessing patient characteristics between HVPCs and non-HVPCs. Models were adjusted for multiple variables, and methods like the Cochran-Armitage trend test and mixed models were employed. Additionally, the study investigated how differences in patient characteristics between HVPCs and non-HVPCs affected mortality rates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated in high-volume pancreatic centers | – | Other: Persons with pancreatic resection in a hospital with at least 50 pancreatic resections annually (observational),Patients treated at a hospital performing at least 50 pancreatic resection procedures annually during 2010 to 2018 |
| Patients treated in low-volume pancreatic centers | – | Other: Persons with pancreatic resection in a hospital not performing at least 50 pancreatic resections annually (observational),Patients not treated at a hospital performing at least 50 pancreatic resection procedures annually during 2010 to 2018 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population encompasses all patients that underwent any pancreatic resection procedure in any German hospital (full survey of the German population).
Key inclusion criteria (1 listed)
- partial or total pancreatic resections between 2010 and 2018
Key exclusion criteria (3 listed)
- childhood (<18 years)
- subjects with a pancreatic transplantation procedure
- missing information on age or gender
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 |
|---|---|---|
| Persons with pancreatic resection in a hospital with at least 50 pancreatic resections annually (observational),Persons that have undergone a pancreatic resection at a hospital with at least 50 pancreatic resections annually (observational) | Other | Patients treated in high-volume pancreatic centers |
| Persons with pancreatic resection in a hospital not performing at least 50 pancreatic resections annually (observational),Persons that have undergone a pancreatic resection at a hospital with not at least 50 pancreatic resections annually (observational) | Other | Patients treated in low-volume pancreatic centers |
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 30 Apr 2024.
- Derived from this study: PubMed 40134472Mantke R, Seliger B, Ogino S, Buchler MW, Hunger R. Not Only Caseload but Also Patient Selection Is Predictive of Mortality After Pancreatic Resection. Ann Surg Open. 2024 Dec 30;6(1):e536. doi: 10.1097/AS9.0000000000000536. eCollection 2025 Mar.
- Individual participant dataSharing planned: No. 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 1 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 30 Apr 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?
On the ClinicalTrials.gov record for NCT06390891, which also lists 1 linked publication.
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 30 Apr 2024.