Aún no reclutaNCT07900776Registro de ClinicalTrials.gov

AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using Endoscopic Ultrasound

Autoimmune Pancreatitis · Pancreatic Ductal Adenocarcinoma (PDAC)

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: Observacional
Fase: No aplica / no indicada
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 690 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Focal autoimmune pancreatitis (f-AIP) and pancreatic ductal adenocarcinoma (PDAC) exhibit substantial overlap in clinical manifestations and imaging features, posing a major diagnostic challenge in pancreatic diseases. Given the marked differences in treatment strategies and prognosis, accurate differentiation is essential to avoid unnecessary surgery and ensure timely initiation of anticancer treatment.

This study aims to collect endoscopic ultrasound (EUS) images from patients with confirmed f-AIP or PDAC across multiple centers, using a previously established multicenter database. Data collected before January 2026 will be used to develop an artificial intelligence (AI) model based on EUS radiomics for differential diagnosis. Subsequently, prospectively collected data from participating centers from 2026 onward will be used for model testing and validation. The diagnostic performance of the model will be evaluated and compared with that of endoscopists with different levels of experience.

Furthermore, this study will investigate the clinical value of interpretable radiomic features, with particular emphasis on challenging diagnostic scenarios, including IgG4-negative AIP, AIP with elevated carbohydrate antigen 19-9 (CA19-9) levels, and PDAC with imaging features resembling those of AIP. The ultimate goal is to provide a reliable tool for accurate, noninvasive preoperative differential diagnosis while promoting the standardization of multicenter AIP databases and the sharing and utilization of imaging data resources.

¿Quién podría participar?

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Inclusion C\*\*Inclusion Criteria:\*\*

\*\*1. Focal Autoimmune Pancreatitis (f-AIP) Group\*\*

Diagnosis of type 1 or type 2 autoimmune pancreatitis (AIP) according to the 2023 Chinese guidelines for the diagnosis and treatment of AIP or the 2011 International Consensus Diagnostic Criteria.
Imaging evidence of a focal pancreatic mass confined to a specific pancreatic segment.
Preoperative endoscopic ultrasound (EUS) examination with at least five clear images of the lesion obtained from different imaging planes.
Histopathological confirmation of AIP based on EUS-guided fine-needle aspiration/biopsy (EUS-FNA/FNB) or surgical pathology.
Complete clinical data, including demographic characteristics, serological findings, imaging results, treatment information, and follow-up records.
Written informed consent from the patient or legal representative, as applicable.

\*\*2. Pancreatic Ductal Adenocarcinoma (PDAC) Group\*\*

Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDAC) by EUS-FNA/FNB or surgical pathology.
Preoperative EUS examination with at least five clear images of the lesion obtained from different imaging planes.
A pancreatic parenchymal lesion comparable to f-AIP, with a maximum diameter of 5 cm or less.
Complete clinical data, including demographic characteristics, serological findings, imaging results, treatment information, and follow-up records.
Written informed consent from the patient or legal representative, as applicable.

\*\*Exclusion Criteria:\*\*

The following criteria apply to both groups:

Poor-quality EUS images, including severe blurring, artifacts, or inadequate lesion visualization, preventing radiomic analysis.
Uncertain or inconclusive pathological diagnosis.
Concurrent pancreatic diseases, such as acute pancreatitis, non-AIP chronic pancreatitis, pancreatic cystic neoplasms, or pancreatic neuroendocrine tumors.
Previous treatment for pancreatic disease, including corticosteroid therapy, chemotherapy, radiotherapy, or surgery, before EUS examination.
Missing essential clinical or imaging data.
Pregnancy or breastfeeding.
Inability to complete the required study-related examinations.iteria:

Exclusion Criteria:

Población del estudio

This multicenter ambispective observational study will include patients with confirmed focal autoimmune pancreatitis (f-AIP) or pancreatic ductal adenocarcinoma (PDAC) who undergo endoscopic ultrasound (EUS) examination at participating hospitals in China. The retrospective cohort will include at least 450 patients (150 with f-AIP and 300 with PDAC) for AI model development and internal validation. An independent prospective cohort will include at least 240 patients (80 with f-AIP and 160 with PDAC) for external validation. EUS images, clinical characteristics, laboratory findings, and pathological data will be collected. All examinations and treatments will follow routine clinical practice, without study-specific interventions.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No informado
Enmascaramiento: No informado

Focal Autoimmune Pancreatitis (f-AIP) Group

Patients diagnosed with focal autoimmune pancreatitis (f-AIP) according to established diagnostic criteria. Eligible patients will undergo endoscopic ultrasound (EUS) as part of routine clinical care. EUS images, clinical characteristics, laboratory findings, and relevant pathological data will be collected for the development and validation of an artificial intelligence-based differential diagnostic model. Both retrospective and prospective cases will be included. No study-specific interventions will be performed.

Pancreatic Ductal Adenocarcinoma (PDAC) Group

Patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) who have undergone endoscopic ultrasound (EUS) as part of routine clinical care. EUS images, clinical characteristics, laboratory findings, and relevant pathological data will be collected for comparison with patients with f-AIP and for the development and validation of an artificial intelligence-based differential diagnostic model. Both retrospective and prospective cases will be included. No study-specific interventions will be performed.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Area Under the Receiver Operating Characteristic Curve (AUC) of the AI Model for Differentiating f-AIP From PDAC

Plazo: At completion of data collection and diagnostic assessment in the prospective validation cohort, through December 2028.

The diagnostic performance of the multimodal artificial intelligence (AI) model in differentiating focal autoimmune pancreatitis (f-AIP) from pancreatic ductal adenocarcinoma (PDAC) will be evaluated using the area under the receiver operating characteristic curve (AUC) in an independent prospective multicenter validation cohort. The AUC ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination), with higher values indicating better diagnostic performance. The AUC and its 95% confidence interval will be calculated.