Role of Patient Selection for Pancreatic Resections (PatSelPanc)

Importance of Patient Characteristics in Identifying and Selecting Patients Suitable for Pancreatic Resection

Pancreatic surgery is complicated and risky, especially for pancreatic cancer. It's been noticed that having these surgeries done at specialized centers can lead to better outcomes and survival rates. However, factors like patient selection and hospital conditions also play an important role. Some studies show that more surgeries done at a hospital might not always mean better results, as the type of patients and procedures can vary. To understand this better, the present study compared outcomes and patient characteristics between high-volume pancreatic centers and others.

Study Overview

• Status: Completed
• Conditions: Pancreas Disease
• Intervention / Treatment: Other: Persons with pancreatic resection in a hospital with at least 50 pancreatic resections annually (observational),; Other: Persons with pancreatic resection in a hospital not performing at least 50 pancreatic resections annually (observational),

Detailed Description

The study utilized German nationwide administrative data (diagnosis-related group statistics) spanning from 2010 to 2018. Persons who underwent pancreatic resections during this period were included, with exclusions for certain criteria like underage and type of procedure. Various factors including patient demographics, diagnoses, procedures, and comorbidities were analyzed to assess in-hospital mortality rates. High-volume pancreatic centers (HVPCs) were identified as those performing at least 50 procedures annually. Statistical analyses included comparing crude and adjusted mortality rates and assessing patient characteristics between HVPCs and non-HVPCs. Models were adjusted for multiple variables, and methods like the Cochran-Armitage trend test and mixed models were employed. Additionally, the study investigated how differences in patient characteristics between HVPCs and non-HVPCs affected mortality rates.

• Study Type: Observational
• Enrollment (Actual): 86073

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-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).

Description

Inclusion Criteria:

• partial or total pancreatic resections between 2010 and 2018

Exclusion Criteria:

• childhood (<18 years)
• subjects with a pancreatic transplantation procedure
• missing information on age or gender

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated in high-volume pancreatic centers; Patients treated at a hospital performing at least 50 pancreatic resection procedures annually during 2010 to 2018	Other: Persons with pancreatic resection in a hospital with at least 50 pancreatic resections annually (observational),; Persons that have undergone a pancreatic resection at a hospital with at least 50 pancreatic resections annually (observational)
Patients treated in low-volume pancreatic centers; Patients not treated at a hospital performing at least 50 pancreatic resection procedures annually during 2010 to 2018	Other: Persons with pancreatic resection in a hospital not performing at least 50 pancreatic resections annually (observational),; Persons that have undergone a pancreatic resection at a hospital with not at least 50 pancreatic resections annually (observational)

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
• 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, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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