NCT06389890

Brief Summary

The main objective of the study is to identify the optimal annual number of cases in a hospital with regard to minimising hospital mortality in pancreatic surgery. In particular, the prognostic value of such case numbers will be analysed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

10 years

First QC Date

March 15, 2024

Last Update Submit

April 25, 2024

Conditions

Volume-Outcome Relationship in Pancreatic Surgery

Keywords

Outcome AssessmentGeneral SurgeryPancreatic SurgeryPublic HealthHospital PlanningCentralized Hospital Services

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    Patient died during or after surgery

    within 30 days

Study Arms (6)

All patients undergoing pancreatic surgery

All patients with at least one pancreatic surgery procedure code

Procedure: Pancreatic resection procedure

Subgroup: Total pancreatectomy

All patients with at least one of the following pancreatic procedure codes (OPS-codes): '55250', '55251', '55252', '5525x', '5525y'

Procedure: Pancreatic resection procedure

Subgroup: Pancreaticoduodenectomy

All patients with at least one of the following pancreatic procedure codes (OPS-codes): '55241', '55242', '55243'

Procedure: Pancreatic resection procedure

Subgroup: Segmental resection

All patients with at least one of the following pancreatic procedure code (OPS-codes): '55244'

Procedure: Pancreatic resection procedure

Subgroup: Distal pancreatectomy

All patients with at least one of the following pancreatic procedure codes (OPS-codes): '55240', '552400', '552401', '552402'

Procedure: Pancreatic resection procedure

Subgroup: Other partial resections

All patients with at least one of the following pancreatic procedure codes (OPS-codes): '5524x', '5524y'

Procedure: Pancreatic resection procedure

Interventions

Pancreatic resection procedurePROCEDURE

Pancreatic resection procedure

All patients undergoing pancreatic surgerySubgroup: Distal pancreatectomySubgroup: Other partial resectionsSubgroup: PancreaticoduodenectomySubgroup: Segmental resectionSubgroup: Total pancreatectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population encompasses all patients that underwent any pancreatic resection procedure in any German hospital (full survey of the German population).

You may qualify if:

  • at least 18 years old
  • any pancreatic resection procedure
  • operated at any German hospital

You may not qualify if:

  • any transplantation procedure
  • Inpatient admission for organ removal
  • no information on sex
  • no information on age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Rene Mantke, MD

    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
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2024

First Posted

April 29, 2024

Study Start

January 1, 2010

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Data will be analyzed by controlled remote data analysis. The data is held exclusively by the Federal Statistical Office for scientific analyses. Direct access to or data sharing of individual patient data is prohibited by German law.