Validation of Joint-AI in Diagnosing Pancreatic Solid Lesions

Summary

This clinical trial aims to learn if a multimodal artificial intelligence (AI) model can enhance the diagnosis of pancreatic solid lesions. The main questions it aims to answer are:

1. Does the AI model enhance the diagnostic performance of endoscopists in diagnosing pancreatic solid lesions?
2. Does the addition of interpretability analysis further improve the diagnostic performance of the assisted endoscopists? Researchers will compare the diagnostic performance of endoscopists with or without the assistance of the AI model.

Participants will:

1. Their clinical data will be prospectively collected.
2. They will be randomized to the AI-assist group and the conventional diagnosis group.

Conditions

• Pancreatic Cancer
• Pancreatitis
• Pancreatic Neuroendocine Neoplasms (pNETs)
• Autoimmune Pancreatitis
• Solid Pseudopapillary Neoplasm of the Pancreas

Interventions

DIAGNOSTIC_TEST

The assistance of the Joint-AI model

Predictions given by the Joint-AI model will be provided to the endoscopists during their diagnosis

DIAGNOSTIC_TEST

The assistance of the interpretable Joint-AI model

Predictions given by the Joint-AI model and the results of the interpretability analysis will be provided to the endoscopists during their diagnosis

Sponsors & Collaborators

• Beijing Union Hosptial

  collaborator UNKNOWN

• Affiliated Drum Tower Hospital of Nanjing University Medical School

  collaborator UNKNOWN

• Shanghai Longhua Hospital

  collaborator UNKNOWN

• Beijing Friendship Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Huazhong University of Science and Technology

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-31

Primary Completion

2026-01-31

Completion

2026-01-31

Countries

• China

Study Locations