Total Pancreatectomies in Germany - Epidemiology, Trends,

NCT06466928 | Completed

• 1 other identifier: ToPaGe
• Study Type: observational
• Target: 12,938
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreas Disease

Keywords

Specialization; Pancreatic Surgery; Total Resection; Volume-Outcome-Relationship

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Death

  30 days

Study Arms (4)

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

Total pancreatectomy with venous resection

Total pancreatectomy with portal vein and/or superior mesenteric vein resection

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.

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

Procedure: Total pancreatectomy

Interventions

Total pancreatectomy PROCEDURE

Surgical removal of the entire pancreas

Standard Total pancreatectomy; Total pancreatectomy with arterial resection; Total pancreatectomy with multivisceral resection; Total pancreatectomy with venous resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• total pancreatectomy between January 2010 and December 2020
• years or older

You may not qualify if:

• postmortem pancreatectomy (OPS code 5-525.4)
• removal of a pancreas transplant (OPS code 5-525.3)

Sponsors & Collaborators

• Medizinische Hochschule Brandenburg Theodor Fontane: lead
• Margarete-Ammon-Stiftung: collaborator

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Rene Mantke, MD, PhD

  Head of Surgery at University Hospital Brandenburg an der Havel

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgery

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: January 1, 2010
• Primary Completion: December 31, 2020
• Study Completion: June 5, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share