Total Pancreatectomies in Germany - Epidemiology, Trends,

Completed

• Conditions: Pancreas Disease
• Interventions: Procedure: Total pancreatectomy

• Registration Number: NCT06466928
• Lead Sponsor: Medizinische Hochschule Brandenburg Theodor Fontane

Brief 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.

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 Timeline

• Study Start: 2010-01-01
• Primary Completion: 2020-12-31
• Status Verified: 2024-06
• Study Completion: 2024-06-05
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12938

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard Total pancreatectomy	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
Total pancreatectomy with venous resection	Total pancreatectomy	Total pancreatectomy with portal vein and/or superior mesenteric vein resection
Total pancreatectomy with multivisceral resection	Total pancreatectomy	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.
Total pancreatectomy with arterial resection	Total pancreatectomy	Total pancreatectomy with arterial resection: superior mesenteric artery resections, hepatic artery resections, aortic resections, or resections of the celiac axis

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	30 days	Death