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NCT06466928 Clinical Trial

Total Pancreatectomies in Germany - Epidemiology, Trends,

Pancreas Disease Clinical Trial

— ToPaGe  

Official title:
A Nationwide Analysis of Total Pancreatectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06466928
Other study ID # ToPaGe
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date June 5, 2024

Study information
Verified date June 2024
Source Medizinische Hochschule Brandenburg Theodor Fontane
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 12938
Est. completion date June 5, 2024
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - total pancreatectomy between January 2010 and December 2020 - 18 years or older Exclusion Criteria: - postmortem pancreatectomy (OPS code 5-525.4) - removal of a pancreas transplant (OPS code 5-525.3)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Total pancreatectomy
Surgical removal of the entire pancreas

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Medizinische Hochschule Brandenburg Theodor Fontane Margarete-Ammon-Stiftung

Outcome
Type Measure Description Time frame Safety issue
Primary In-hospital mortality Death 30 days
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