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Not yet recruiting NCT06954753

Predicting Cancer in Pancreatic Cystic Lesions Through Artificial Intelligence

— Observational Pancreatic Cancer Pancreatic Cystic Lesions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pancreatic surgery.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Pancreatic Cystic Lesions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Deep Learning for Malignant Degeneration Prediction of Pancreatic Cystic Lesions - Beyond High-risk Stigmata

Overview

This international, multicenter retrospective study aims to develop a deep learning (DL)-based predictive model to identify malignant transformation in pancreatic cystic lesions, improving upon current clinical guidelines. The model will integrate clinical, biochemical, and multimodal imaging data. Several 3D convolutional neural networks will be trained using advanced preprocessing, data augmentation, and hybrid fusion techniques. Model performance will be compared to that of existing international guidelines. The study involves no additional procedures for patients and adheres to strict data anonymization and privacy regulations.

Interventions

  • Procedure Pancreatic surgery
    Pancreatic resective surgery performed for pancreatic cystic lesions with high risk of malignant degeneration based on clinical, biochemical, and/or radiological features following current guidelines on pancreatic cystic lesions management.

Primary outcome measures

  • Prediction of malignant degeneration of pancreatic cystics lesions [Time frame: 90 days from patients hospital discharge.]
Secondary outcome measures (8)
  • Accuracy of performance evaluation [Time frame: 90 days from patients hospital discharge.]
  • Precision of performance evaluation [Time frame: 90 days from patients hospital discharge.]
  • Recall of performance evaluation [Time frame: 90 days from patients hospital discharge.]
  • Balanced accuracy [Time frame: 90 days from patients hospital discharge.]
  • F1-score [Time frame: 90 days from patients hospital discharge.]
  • Confusion matrix [Time frame: 90 days from patients hospital discharge.]
  • Log-loss [Time frame: 90 days from patients hospital discharge.]
  • Cohen's Kappa [Time frame: 90 days from patients hospital discharge.]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with PCL(s ) who underwent pancreatic surgery in one of the participant centers. Surgical indication must adhere to at least one of current guidelines on PCLs management (6), based on clinical, biochemical, and radiological (MR and/or EUS) features.
  • Pancreatic surgery B83performed for supposed increased risk of cyst(s) malignant degeneration following current guidelines on PCLs management (6).
  • Absence of clinical, biochemical, radiological, and anatomopathological evidence of pancreatic cancer at pancreatic surgery.
  • Non-opposition to the anonymous data processing by the included patients.

Exclusion criteria

  • Patients presenting with evidence of pancreatic cancer at surgery.
  • PCL(s) diagnosis and treatment performed without one between EUS and pancreatic MR. surgery performed in the absence of the criteria proposed by current guidelines.
  • Unavailability of both preoperative EUS and pancreatic MR data.
  • Unavailability of postoperative PCL(s) anatomopathological analysis results.
  • SBO diagnosis performed without CT-scan.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06954753 · 25Chirdig01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗