- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436273
Development and Validation of a Risk Prediction Model for New-Onset Diabetes After Pancreatectomy
New-onset diabetes is one of the major complications after pancreatectomy. Without timely diagnosis, treatment and management, it can lead to adverse outcomes such as cardiovascular and cerebrovascular events and severe infections, increasing mortality. Moving the management threshold forward, early risk identification, and precise and effective intervention are the keys to its management.
Existing risk prediction studies show high heterogeneity across different populations and surgical procedures. Risk factors available for early identification remain unclear, and most included factors are non-interventional. There are limitations in study design, modeling and validation methods, and the research results provide limited value for guiding risk prediction, prevention and management.
This study adopts a mixed-methods design. We retrospectively analyze the general and clinical data of patients who underwent pancreatectomy at two institutions, follow up the subjects to determine the incidence of postoperative diabetes and postoperative self-management status, and use regression analysis to identify independent risk factors for new-onset diabetes after surgery.
We separately establish a nomogram model, a random forest model, and a deep learning model, perform internal and external validation, compare the performance of the three models, and select the model with optimal clinical performance. Based on the prediction model and evidence-based medicine, we formulate intervention strategies, evaluate their feasibility through clinical trials, refine the intervention items, and finally establish a precise intervention strategy for new-onset diabetes after pancreatectomy to achieve comprehensive, dynamic, efficient and precise management.
Implementation of this project can reduce the incidence and slow the progression of diabetes after pancreatectomy, improve clinical outcomes, lower readmission and mortality rates, save social medical resources, and provide decision-making guidance and practical evidence for the prevention and control of chronic diseases.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zhejiang
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Ningbo, Zhejiang, China, 312000
- The First Affiliated Hospital of Ningbo University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing pancreatectomy via open, laparoscopic, or robot-assisted approach.
- Age ≥ 18 years.
Exclusion Criteria:
- Patients who underwent total pancreatectomy.
- Patients with a preoperative diagnosis of diabetes.
- Patients with incomplete clinical or follow-up data.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Whether new-onset diabetes occurred
Time Frame: 12months
|
12months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- XiaoyingHeNingbo1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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