Clinical Correlation Study Between Anomalous Pancreaticobiliary Ductal Junction and Malignant Tumors of the Biliary System and the Establishment of an AI-based Automated Recognition System

March 28, 2025 updated by: Lu Wenping, Chinese PLA General Hospital
To explore the occurrence of pancreaticobiliary maljunction (PBM) in the Chinese population, the characteristics of various subtypes, and the relationship between PBM and malignant tumors of the biliary system. To explore the general clinical characteristics of patients with mild bile duct dilation but who have not been clinically diagnosed with choledochal cysts, as well as the relationship between these characteristics and malignant tumors of the biliary system. To develop and evaluate a deep learning method for machine learning of Magnetic resonance cholangiopancreatography (MRCP) images, enabling fully automated detection of pancreaticobiliary maljunction.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2439

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100000
        • Chinese People's Liberation Army General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients with pancreaticobiliary maljunction

Description

Inclusion Criteria:

Cases that were hospitalized and underwent Magnetic resonance cholangiopancreatography (MRCP) examination at the First Medical Center of Chinese People's Liberation Army General Hospital.

Exclusion Criteria:

  1. Patients aged less than 18 years old;
  2. Those with unclear diagnosis;
  3. Cases with missing or poor-quality imaging data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence rate of malignant tumors of the biliary system
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-037-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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