Predicting Cancer in Pancreatic Cystic Lesions Through Artificial Intelligence

NCT06954753 | Not Yet Recruiting

• 1 other identifier: 25Chirdig01
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatic Cancer; Pancreatic Cystic Lesions

Outcome Measures

Primary Outcomes (1)

• Prediction of malignant degeneration of pancreatic cystics lesions

  Predict the presence of malignant degeneration (defined as: high grade dysplasia, in situ PADC, or T1 PADC) in pancreatic cystic lesion(s) using artificial intelligence model based on clinical, biochemical, and radiological features. This will be measured through Area Under the Receiver Operator Characteristic curve (AUROC) assesment. AUROC varies between 0.5 and 1, corresponding to no class separation capacity and full class separation capacity, respectively.

  90 days from patients hospital discharge.

Secondary Outcomes (8)

• Accuracy of performance evaluation

  90 days from patients hospital discharge.

• Precision of performance evaluation

  90 days from patients hospital discharge.

• Recall of performance evaluation

  90 days from patients hospital discharge.

• Balanced accuracy

  90 days from patients hospital discharge.

• F1-score

  90 days from patients hospital discharge.

Study Arms (1)

PCLs patients

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.

Procedure: Pancreatic surgery

Interventions

Pancreatic surgery PROCEDURE

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.

PCLs patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent pancreatic surgery for pancreatic cystic lesions, in the absence of preoperative evidence of cancer. Indication of surgery must be based on one or more current guidelines concerning pancreatic cystic lesions management.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Andrea CHIERICI

CONTACT

+33 0634799833; chierici.ap@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04