Pancreatic Cystic Neoplasms
Conditions
Interventions
AI-assisted decision-making group:Patients will receive AI-assisted clinical management in addition to conventional assessment. Physicians will evaluate patients based on clinical history, laboratory
Conventional management group:Patients will receive standard clinical management according to current guidelines, expert consensus, and physician experience. Physicians will make management decisions
Phase 1 AI Model Development and Validation Observation Group:None
Sponsors
Changhai Hospital,The Navy Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Phase I: AI Model Development and Validation Inclusion criteria: 1.Patients with pathological diagnosis of pancreatic cystic neoplasms (PCNs). 2.Patients who underwent contrast-enhanced multiphasic CT examination within 3 months prior to surgical resection or biopsy. Phase II: Prospective Randomized Controlled Trial (RCT) Inclusion criteria: 1.Patients aged >=18 years. 2.Patients who underwent contrast-enhanced multiphasic CT examination between June 1, 2026, and June 1, 2028. 3.Patients with pancreatic cystic neoplasms confirmed by CT or MRI. 4.Patients who had not previously undergone pancreatic-related surgery or interventional treatment.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1.Patients with poor-quality CT images or incomplete contrast-enhanced phases. 2.Patients who received preoperative chemotherapy, radiotherapy, ablation, or other anti-tumor treatments. 3.Patients with conditions that may significantly interfere with imaging interpretation, such as acute pancreatitis or severe chronic pancreatitis. Phase II: Prospective Randomized Controlled Trial (RCT) Exclusion criteria: 1.Patients with poor-quality CT images or incomplete contrast-enhanced phases. 2.Patients with conditions that may significantly interfere with imaging interpretation, such as acute pancreatitis or severe chronic pancreatitis. 3.Patients who had previously undergone pancreatic surgery or interventional treatment. 4.Patients with confirmed pancreatic malignancies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Receiver Operating Characteristic Curve for Discriminating High-Risk From Non-High-Risk Pancreatic Cystic Neoplasms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Decision-Making Time;Change From Baseline in EQ-5D-5L Quality-of-Life Score at 12 Months;Incremental Cost-Effectiveness Ratio of the AI-Assisted Management Strategy;Participant or Clinician Satisfaction;Accuracy of Pancreatic Cystic Neoplasm Subtype Classification;Incidence of Study-Related Adverse Events and Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactBian Yun
Changhai Hospital,The Navy Military Medical University
Outcome results
None listed