Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT ScanMAAGIENCT07401485
Preclinical Development of a 3D Bili-MRI Reconstruction Tool and an Artificial Intelligence Algorithm to Assist Endoscopists in Performing Endoscopic Retrograde Cholangiopancreatography (ERCP)
An observational study of Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT Scan, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT Scan
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2026to 2 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent ERCP in the endoscopy unit of Saint Antoine Hospital or Mondor Hospital for a biliary condition related to a biliary stricture (benign or malignant), and who had both an MRCP and an abdominal CT scan performed in the imaging departments of Saint Antoine Hospital or Mondor Hospital between 2020 and the end of 2025, and who did not express opposition to the reuse of their data.
Who may be able to join
- 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.
Who cannot join
- -Patients who oppose the reuse of their clinical data for research after receiving the information letter.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service Endoscopie digestive, Saint Antoine APHP
Paris, France, 75012
Marine CAMUS, Pr, +33 1.49.28.33.68, marine.camus@aphp.fr
Aymeric BECQ, Dr, +33 1.49.81.23.51, aymeric.becq@aphp.fr
About this study
Official title: Preclinical Development of a 3D Bili-MRI Reconstruction Tool and an Artificial Intelligence Algorithm to Assist Endoscopists in Performing Endoscopic Retrograde Cholangiopancreatography (ERCP) : MAAGIE
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.
Read the detailed description
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.
This is a bicentric retrospective study based on imaging data collected during routine care. Patients were monitored as part of the usual care pathway for individuals undergoing ERCP in the endoscopy units of Saint Antoine Hospital or Henri Mondor Hospital for a biliary condition related to a biliary stricture (benign or malignant). The research does not alter patient management in any way.
The first step will involve identifying all patients who underwent ERCP in the endoscopy units of Saint Antoine Hospital or Mondor Hospital for a biliary condition related to a biliary stricture (benign or malignant) and who had both an MRCP and an abdominal CT scan performed in the imaging departments of the same hospitals, from 2020 through the end of 2025.
After verifying eligibility criteria, a specific information notice about this study will be sent to them. If no response is received within one month, the collected data may be reused for research purposes.
The imaging data collected will support the development and validation of 3D reconstruction/registration software (3D modeling of the biliary tract using mathematical algorithms for medical imaging and artificial intelligence networks applied to the acquired images).
Pseudonymized data will be centralized under the supervision of Prof. Camus on a secure AP-HP server, with a correspondence table created for follow-up, accessible only to Prof. Camus. At the end of the study, data will be securely transferred to the partners for analysis and tool development. All data transfers will be performed using secure, encrypted external storage devices according to local AP-HP IT department procedures.
The data volume is determined based on image-processing capacity and technological development goals. A dataset of 100 patients provides sufficient anatomical variability to train and test AI models.
No inferential statistical analysis is planned. Tool performance will be evaluated using image-quality metrics (DSC, IoU) and localization error indicators for the algorithms. Finally, exchanges with project partners will support the development and validation of the 3D reconstruction tool. The analysis will be conducted by the partner teams at LIP6 and ISIR.
- Conditions
- Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT Scan
- Being tested
- retrospective study based on data already collected during routine care (no intervention)
- Keywords
- ERCP, 3D ERCP, biliary tree, cholangiocarcinoma, biliary stricture, 3D navigation, endoscopy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective study based on data already collected during routine care (no intervention)Other
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
What is being measured
The primary outcome is the main question the study is designed to answer.
medical softaware and/or solution to guide stent placement in complex hilar biliary stricture
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.
Measured: 4 years (2020 - 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completion2 Mar 2026 (estimated)
- Study completion2 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT ScanStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine CAMUS, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401485
- Sponsor's protocol ID
- APHP250411
- Acronym
- MAAGIE
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Development of a 3D Bili-MRI Reconstruction Tool and an Artificial Intelligence Algorithm to Assist Endoscopists in Performing Endoscopic Retrograde Cholangiopancreatography (ERCP) : MAAGIE
- ClinicalTrials.gov ID
- NCT07401485
- Acronym / sponsor ID
- MAAGIE / APHP250411
- Conditions
- Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT Scan
- Keywords
- ERCP, 3D ERCP, biliary tree, cholangiocarcinoma, biliary stricture, 3D navigation, endoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 2 Jul 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This is a bicentric retrospective study based on imaging data collected during routine care. Patients were monitored as part of the usual care pathway for individuals undergoing ERCP in the endoscopy units of Saint Antoine Hospital or Henri Mondor Hospital for a biliary condition related to a biliary stricture (benign or malignant). The research does not alter patient management in any way.
The first step will involve identifying all patients who underwent ERCP in the endoscopy units of Saint Antoine Hospital or Mondor Hospital for a biliary condition related to a biliary stricture (benign or malignant) and who had both an MRCP and an abdominal CT scan performed in the imaging departments of the same hospitals, from 2020 through the end of 2025.
After verifying eligibility criteria, a specific information notice about this study will be sent to them. If no response is received within one month, the collected data may be reused for research purposes.
The imaging data collected will support the development and validation of 3D reconstruction/registration software (3D modeling of the biliary tract using mathematical algorithms for medical imaging and artificial intelligence networks applied to the acquired images).
Pseudonymized data will be centralized under the supervision of Prof. Camus on a secure AP-HP server, with a correspondence table created for follow-up, accessible only to Prof. Camus. At the end of the study, data will be securely transferred to the partners for analysis and tool development. All data transfers will be performed using secure, encrypted external storage devices according to local AP-HP IT department procedures.
The data volume is determined based on image-processing capacity and technological development goals. A dataset of 100 patients provides sufficient anatomical variability to train and test AI models.
No inferential statistical analysis is planned. Tool performance will be evaluated using image-quality metrics (DSC, IoU) and localization error indicators for the algorithms. Finally, exchanges with project partners will support the development and validation of the 3D reconstruction tool. The analysis will be conducted by the partner teams at LIP6 and ISIR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent ERCP in the endoscopy unit of Saint Antoine Hospital or Mondor Hospital for a biliary condition related to a biliary stricture (benign or malignant), and who had both an MRCP and an abdominal CT scan performed in the imaging departments of Saint Antoine Hospital or Mondor Hospital between 2020 and the end of 2025, and who did not express opposition to the reuse of their data.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Patients who oppose the reuse of their clinical data for research after receiving the information letter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | – |
Primary outcome
medical softaware and/or solution to guide stent placement in complex hilar biliary stricture
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marine CAMUS, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Biliary Stricture Treated During ERCP With Available MRCP and Abdominal CT Scan, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marine CAMUS, Pr (+33 1.49.28.33.68, marine.camus@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medical softaware and/or solution to guide stent placement in complex hilar biliary stricture (time frame: 4 years (2020 - 2025)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.