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Starting soon Observational

Preclinical Development of a 3D Bili-MRI Reconstruction Tool and an Artificial Intelligence Algorithm to Assist Endoscopists in Performing Endoscopic Retrograde Cholangiopancreatography (ERCP)

NCT07401485 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-03-02
Last updated
2026-02-10

Condition(s) studied

Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT Scan

Investigational drug(s) / intervention(s)

retrospective study based on data already collected during routine care (no intervention)

retrospective study based on data already collected during routine care (no intervention): Identification of all patients treated by CPRE in the endoscopy department of Saint Antoine Hospital or Mondor Hospital for a biliary condition related to biliary stenosis (benign or malignant) and who have had a biliary MRI and abdominal CT scan in the imaging department of Saint Antoine Hospital or Mondor Hospital: from 2020 until the end of 2025 Collection of imaging data provided

Study summary

ERCP is a complex interventional endoscopic procedure based on 2D visualization of the biliary tract. 3D modeling and AI are promising solutions to improve navigation and safety during ERCP.

The MAAGIE project was designed to create one of these innovative solutions and received ANR funding in 2024. It includes several Work Packages, among which the first WP involves creating a database from imaging data of the biliary tract already collected during clinical care.

The main objective of our study will be to develop and validate a tool that enables 3-dimensional modeling of the biliary tract from preoperative MRCP and abdominal CT scan sequences, allowing better visualization and understanding of patients' biliary anatomy before and during ERCP.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18 years or older. * Patients treated by ERCP in the endoscopy unit of Saint Antoine Hospital or Henri Mondor Hospital for a biliary condition related to a biliary stricture (benign or malignant). * Patients who underwent an MRCP and an abdominal CT scan in the imaging department of Saint Antoine Hospital or Henri Mondor Hospital as part of their clinical care. Exclusion Criteria: -Patients who oppose the reuse of their clinical data for research after receiving the information letter.

Primary outcome measure(s)

  • medical softaware and/or solution to guide stent placement in complex hilar biliary stricture — 4 years (2020 - 2025)
    To develop and validate a tool enabling three-dimensional modeling of the biliary tract from preoperative MRCP and abdominal CT scan sequences, providing improved visualization and a better understanding of patients' biliary anatomy before and during ERCP.

Trial sites (1)

FacilityCityRegionStatus
Service Endoscopie digestive, Saint Antoine APHP Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07401485 on ClinicalTrials.gov ↗ ← All trials in France