AI Evaluation of Pancreatic Exocrine Insufficiency in CP Patients

NCT06278272 | Completed

• 1 other identifier: AIPEI
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

Early assessment of pancreatic exocrine insufficiency (PEI) is crucial for determining appropriate chronic pancreatitis (CP) treatment plans, thereby avoiding unnecessary suffering and further complications in patients. A total of 504 patients with CP who underwent fecal elastase-1 test and contrast-enhanced CT at Changhai Hospital between January 2018 and April 2023 were enrolled in this study. The investigators aim to establish a fully automated workflow to establish a PEI classification model based on radiomic features, semantic features and deep learning features on enhanced CT images for evaluating the severity of PEI.

Conditions

Chronic Pancreatitis; Exocrine Pancreatic Insufficiency; Machine Learning; Deep Learning

Outcome Measures

Primary Outcomes (1)

• Classification of pancreatic exocrine insufficiency

  Pancreatic exocrine insufficiency are classified by FE-1 test into severe (0-100), mild to moderate (100-200) and normal (\>200).

  Up to 10 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 504 patients with CP who underwent the FE-1 test and CE-CT at Changhai Hospital between January 2018 and April 2023 were enrolled in this study. the exclusion criteria were as follows: (a) enhanced CT was taken during the acute episode of chronic pancreatitis, (b) history of malignant tumor, (c) previous pancreatic surgery, (4) systemic diseases, and (5) poor image quality or image loss

You may qualify if:

• gender and age are not restricted
• diagnosis of chronic pancreatitis
• fe-1 test was conducted following recent pancreatic enhanced CT
• sign informed consent

You may not qualify if:

• enhanced CT was taken during the acute episode of chronic pancreatitis
• history of malignant tumor
• previous pancreatic surgery
• systemic diseases
• poor image quality or image loss

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 26, 2024
• Study Start: March 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-01

Locations

CN (1)