Predicting Cancer in Pancreatic Cystic Lesions Through Artificial Intelligence

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Prediction of malignant degeneration of pancreatic cystics lesions [Срок оценки: 90 days from patients hospital discharge.]

Вторичные конечные точки (8)

• Accuracy of performance evaluation [Срок оценки: 90 days from patients hospital discharge.]
• Precision of performance evaluation [Срок оценки: 90 days from patients hospital discharge.]
• Recall of performance evaluation [Срок оценки: 90 days from patients hospital discharge.]
• Balanced accuracy [Срок оценки: 90 days from patients hospital discharge.]
• F1-score [Срок оценки: 90 days from patients hospital discharge.]
• Confusion matrix [Срок оценки: 90 days from patients hospital discharge.]
• Log-loss [Срок оценки: 90 days from patients hospital discharge.]
• Cohen's Kappa [Срок оценки: 90 days from patients hospital discharge.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06954753 · 25Chirdig01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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