NCT07919704Not yet recruiting
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Artificial Intelligence-Assisted Differentiation of Pancreatic Mucinous Cystic Neoplasms, Serous Cystic Neoplasms, and Pseudocysts Using Endoscopic Ultrasound Images and Clinical Features: An Ambispective Observational Study
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
Pancreatic mucinous cystic neoplasms (MCNs), serous cystic neoplasms (SCNs), and pancreatic pseudocysts (PPCs) often exhibit overlapping imaging features on endoscopic ultrasound (EUS). However, these conditions require different clinical management strategies. Accurate differentiation is therefore important for appropriate treatment planning. This study aims to develop and validate an artificial intelligence (AI) model that integrates EUS images and clinical features to differentiate MCNs, SCNs, and PPCs. The study is designed as an ambispective observational diagnostic study consisting of retrospective model development, prospective temporal validation, and a reader study involving EUS physicians. Approximately 400 adult patients with confirmed MCN, SCN, or PPC will be included. Retrospective clinical data and EUS images will be used for model development and internal validation. After model development is completed, newly diagnosed patients will be prospectively enrolled to independently evaluate the diagnostic performance of the model. The primary outcome is the patient-level macro-averaged area under the receiver operating characteristic curve (macro-AUROC) for three-class classification in the prospective validation cohort. Secondary outcomes include diagnostic accuracy, sensitivity, specificity, calibration, clinical net benefit, and the performance of EUS physicians with and without AI assistance. This study is expected to provide evidence for the potential clinical value of AI-assisted differentiation of pancreatic cystic lesions. No additional invasive procedures or study-specific treatments will be performed.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 22 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT07919704
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Nov 2026 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had an endoscopic ultrasound (EUS) exam and were finally diagnosed with a pancreatic mucinous cystic neoplasm, serous cystic neoplasm, or pseudocyst.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- A final diagnosis of pancreatic mucinous cystic neoplasm (MCN), serous cystic neoplasm (SCN), or pancreatic pseudocyst (PPC). MCN and SCN must be confirmed by surgery or tissue examination.
- Earlier treatment
- The EUS exam must have been done before surgery, ablation, drainage, or other treatment of the lesion.
Main reasons for not taking part
- Other pancreatic lesions such as IPMN, solid pseudopapillary neoplasm, cystic neuroendocrine tumor, or cystic degeneration of a solid tumor
- No clear EUS image of the lesion, or very poor image quality
- Only EUS images taken after treatment or surgery
- Diagnosis still uncertain or disputed after expert review
- Refusing or withdrawing consent in the prospective phase
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- -
Who the study is looking for
- **Inclusion Criteria:**
- Adults aged 18 years or older, regardless of sex.
- Patients who have undergone endoscopic ultrasound (EUS) examination.
- A final diagnosis of pancreatic mucinous cystic neoplasm (MCN), serous cystic neoplasm (SCN), or pancreatic pseudocyst (PPC).
- For MCN and SCN, a confirmed diagnosis based on surgical or histopathological findings.
- For PPC, a diagnosis established according to a predefined composite reference standard incorporating clinical history, imaging findings, and relevant diagnostic evidence.
- Availability of at least one EUS image clearly showing the target lesion.
- EUS examination performed before surgery, ablation, drainage, or other treatment of the target lesion.
- Availability of essential clinical information corresponding to the EUS examination.
- For the prospective validation cohort, enrollment after model finalization and provision of written informed consent according to the approved ethics protocol.
- **Exclusion Criteria:**
- Severely degraded EUS image quality preventing reliable identification of the target lesion.
- Availability of only post-treatment or postoperative EUS images, without pretreatment imaging.
- Lack of reliable pathological confirmation for MCN or SCN.
- Inability to establish a clear correspondence between the EUS images and the pathologically confirmed lesion.
- Uncertain or disputed final diagnosis that remains unresolved after expert review.
- Concurrent pancreatic cystic neoplasms for which the target lesion cannot be clearly identified.
- Other pancreatic lesions, including intraductal papillary mucinous neoplasms (IPMNs), solid pseudopapillary neoplasms (SPNs), cystic neuroendocrine tumors, or cystic degeneration of solid tumors.
- Substantial missing clinical information preventing multimodal analysis.
- Refusal to provide or withdrawal of informed consent during the prospective phase.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.