Total Pancreatectomies in Germany - Epidemiology, Trends, (ToPaGe)

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.

Study Overview

• Status: Completed
• Conditions: Pancreas Disease
• Intervention / Treatment: Procedure: Total pancreatectomy

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 Type: Observational
• Enrollment (Actual): 12938

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population encompasses all patients that underwent total pancreatectomy in any German hospital (full survey of the German population).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: Total pancreatectomy; Surgical removal of the entire pancreas
Total pancreatectomy with venous resection; Total pancreatectomy with portal vein and/or superior mesenteric vein resection	Procedure: Total pancreatectomy; Surgical removal of the entire pancreas
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.	Procedure: Total pancreatectomy; Surgical removal of the entire pancreas
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	Procedure: Total pancreatectomy; Surgical removal of the entire pancreas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Death	30 days

Collaborators and Investigators

• Sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
• Collaborators: Margarete-Ammon-Stiftung
• Investigators: Study Director: Rene Mantke, MD, PhD, Head of Surgery at University Hospital Brandenburg an der Havel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): June 5, 2024

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pancreatic Surgery; Specialization; Volume-Outcome-Relationship; Total Resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: ToPaGe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No Data is held by the Federal Statistical Office of Germany. Individual participant data is not available for data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No