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Development and Prospective Validation of an AI-Based Diagnostic Model for Hepato-Pancreato-Biliary Diseases

The rapid advancement of artificial intelligence (AI) has expanded its applications in healthcare, particularly in diagnostic assistance, intelligent triage, and patient interaction. Hepatobiliary and pancreatic diseases (such as liver cancer, pancreatic cancer, cirrhosis) are characterized by insidious onset, rapid progression, low early-diagnosis rates, and poor prognosis. However, grassroots medical institutions in China face challenges including physician shortages, variable patient health literacy, and incomplete initial information collection, leading to high misdiagnosis/missed diagnosis risks.

Recent breakthroughs in large language models (LLMs) and multi-agent systems (MAS) offer new solutions. LLMs enable advanced natural language processing, while MAS coordinates specialized agents for complex decision-making. Integrating MAS with medical LLMs could create intelligent pre-consultation systems that systematically collect patient symptoms, risk factors, family history, and lifestyle data to enhance diagnostic efficiency.

This study aims to develop a MAS-based pre-consultation system for hepatobiliary-pancreatic diseases featuring four specialized agents ("guidance agent," "medical history agent," "risk assessment agent," and "summary generation agent"). The system will simulate clinical reasoning to generate structured diagnostic reports for physicians.

Research Objectives:

Develop a specialized multi-agent framework combining LLMs to simulate clinical diagnostic logic and standardize symptom collection Enhance pre-consultation data integrity through intelligent dialogue focusing on key disease indicators Generate structured diagnostic summaries highlighting critical symptoms and risk factors Establish foundation for clinical validation and application through expert evaluation and user feedback This pre-diagnostic tool will assist physicians rather than replace clinical judgment, promoting safe, effective AI applications in early disease screening and tiered healthcare systems.

調査の概要

詳細な説明

With the rapid development of artificial intelligence (AI) technologies, their applications in the healthcare field have become increasingly widespread, particularly demonstrating significant potential in diagnostic assistance, intelligent triage, and patient interaction. Hepatobiliary and pancreatic diseases (e.g., liver cancer, pancreatic cancer, bile duct cancer, cirrhosis) are characterized by insidious onset, rapid progression, low early diagnostic rates, and poor prognosis. Clinical diagnosis and treatment demand high requirements for early recognition and precise evaluation. However, grassroots medical institutions in China commonly face challenges such as insufficient specialist physicians, heterogeneous patient health literacy, and inadequate initial information collection during first visits, leading to a high risk of missed or incorrect diagnoses and delays in optimal intervention timing.

In recent years, large language models (LLMs) have achieved breakthrough advancements in natural language understanding and generation, providing a technical foundation for constructing intelligent, personalized medical dialogue systems. Multi-agent systems (MAS) simulate collaborative workflows among multiple specialized roles, enabling more complex and structured decision-making processes with notable advantages in task decomposition, knowledge integration, and dynamic reasoning. Integrating multi-agent architectures with medical LLMs offers the potential to develop intelligent pre-consultation systems with domain-specific expertise, enabling systematic collection and preliminary analysis of critical patient information-including symptoms, risk factors, family history, and lifestyle-to enhance the efficiency and completeness of medical consultations.

This study aims to develop an intelligent pre-consultation LLM system for hepatobiliary and pancreatic diseases based on a multi-agent architecture. By establishing clearly defined "guidance agents," "medical history collection agents," "risk assessment agents," and "physician summary generation agents," the system will simulate clinical diagnostic logic, proactively guide patients through structured disease presentations, and automatically generate initial diagnostic reports compliant with clinical standards for physician reference. This system seeks to assist grassroots physicians in improving early recognition of hepatobiliary and pancreatic diseases, optimize outpatient resource allocation, and enhance patient healthcare experiences.

Research Objectives:

This study aims to design, develop, and preliminarily validate an intelligent pre-consultation LLM system for hepatobiliary and pancreatic diseases based on a multi-agent architecture, exploring its feasibility and potential value in clinical pre-consultation scenarios. Specific objectives include:

Establishing a specialized multi-agent collaborative framework: Leveraging LLM technology, design a multi-agent system capable of division of labor and collaboration, incorporating modules such as guidance, medical history collection, preliminary risk screening, and report generation. By simulating the diagnostic logic and reasoning pathways of clinical physicians, the system will achieve systematic, structured information collection for hepatobiliary and pancreatic disease-related symptoms.

Enhancing the completeness and accuracy of pre-consultation information: Through intelligent dialogue, proactively guide patients to review and articulate their medical history, prioritizing key risk factors for hepatobiliary and pancreatic diseases-including jaundice, abdominal pain, weight loss, alcohol consumption history, history of viral hepatitis, and family history of cancer-to improve patient self-reporting completeness and reduce information omissions caused by memory biases or unclear expression.

Generating structured initial diagnostic assistance reports: Automatically integrate patient-reported symptoms and medical history into pre-consultation summaries adhering to clinical documentation standards, highlighting critical physical signs and risk alerts. This will assist physicians in rapidly grasping patient profiles, shortening outpatient consultation times, and improving diagnostic efficiency.

Laying the foundation for subsequent clinical validation and application: Through small-scale simulation testing and expert evaluation, preliminarily verify the system's usability and clinical alignment, collect feedback from physicians and patients, and optimize interactive workflows. This will provide scientific evidence and ethical compliance support for future prospective clinical studies and product development.

This research is not intended for direct clinical diagnosis or treatment decisions but rather as an information-assistance tool for physicians prior to consultations. It aims to promote safe, effective, and equitable applications of AI in the early screening of hepatobiliary and pancreatic diseases and tiered healthcare delivery systems.

研究の種類

観察的

入学 (推定)

400

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

確率サンプル

調査対象母集団

The study population will consist of adult outpatients (aged 18-75 years) with suspected or confirmed hepatobiliary and pancreatic diseases (e.g., liver cancer, pancreatic cancer, cholangiocarcinoma, cirrhosis) who are scheduled for routine outpatient consultations at participating healthcare institutions. Participants must demonstrate sufficient cognitive function (Mini-Mental State Examination [MMSE] score ≥24) and proficiency in Mandarin or English to ensure effective interaction with the AI multi-agent system. All individuals must provide written informed consent and be capable of completing all study procedures, including structured interactions with the AI system and follow-up physician evaluations.

説明

Inclusion Criteria:

  • Age and Gender: Patients aged 18 to 75 years, of either sex.
  • Clinical Diagnosis Requirements: Suspected or confirmed hepatobiliary or pancreatic diseases (e.g., liver cancer, pancreatic cancer, cholangiocarcinoma, cirrhosis) based on preliminary clinical evaluation.
  • Ability to provide a complete medical history and symptoms for AI system interaction.
  • Cognitive and Physical Capacity:
  • Sufficient cognitive function to complete interactions with the AI multi-agent system independently (verified by Mini-Mental State Examination [MMSE] score ≥24).
  • Proficiency in Mandarin or English to ensure accurate communication with the system.
  • Consent and Compliance: Willingness to participate and provide written informed consent.
  • Ability to complete all study procedures, including physician consultations and follow-up assessments.
  • Clinical Workflow Compatibility: Scheduled for outpatient consultation at participating healthcare facilities.

Exclusion Criteria:

  • Patients with life-threatening conditions requiring immediate intervention (e.g., acute hepatic failure, severe hemorrhage).
  • Presence of severe cardiovascular or cerebrovascular diseases that may interfere with study participation.
  • Cognitive or Communication Barriers:
  • Cognitive impairment (MMSE score <24) or language barriers preventing effective interaction with the AI system.
  • Psychiatric disorders or altered mental status affecting decision-making capacity.
  • Prior or Concurrent Participation:
  • Enrollment in other interventional clinical trials that may confound the study outcomes.
  • Current use of experimental diagnostic tools or AI systems outside the study protocol.
  • Technical or Logistical Constraints:
  • Inability to access or operate electronic devices required for AI system interaction (e.g., touchscreen terminals, mobile apps).
  • Lack of stable internet connectivity for system access.
  • Ethical or Legal Restrictions: Pregnancy or lactation (to avoid potential risks not directly related to the study).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Experimental Group 1
Patients in this group will first complete a full interaction with the multi-agent system described above until the Arbiter confirms the medical record is error-free. The system will then generate a structured "Case Characteristics" summary and an initial diagnostic recommendation produced by the Oracle. However, this complete AI-generated output will not be displayed to the subsequent attending physician. The physician will then conduct an independent routine consultation following standard clinical protocols. The medical records generated by the physician are solely for maintaining the integrity of clinical workflows and will not be used as evaluation metrics for this study. The core assessment objective for this group is to evaluate the concordance between the AI-generated final medical records and the predefined gold standard.
Patients first complete a full interaction with the multi-agent system until the Arbiter confirms the medical record is error-free. The system then generates a structured "Case Characteristics" (CC) summary and preliminary diagnostic recommendations via the Oracle Agent. However, the complete AI output is not displayed to the subsequent attending physician. The physician conducts an independent consultation following standard clinical protocols, and their medical records are solely used to maintain clinical workflow integrity and are not evaluated as part of this study. The core assessment objective for this group is the concordance between the AI-generated final medical records and the gold-standard reference.
Experimental Group 2
Patients in this group will complete the interaction with the multi-agent system and confirm the final "Case Characteristics" (CC). The system will then push this structured CC summary (excluding the Oracle's diagnostic recommendations to avoid excessive guidance) to the attending physician's electronic workstation in a standardized format. Prior to the formal consultation, physicians may refer to this summary to adjust their interview priorities, verify information accuracy, or supplement missing details. The medical records written by the physicians will serve as the primary evaluation metrics for this group.
After patients finalize the CC through interaction with the multi-agent system, the structured "Case Characteristics" (excluding Oracle-generated diagnostic advice to avoid over-guidance) are pushed in a standardized format to the corresponding physician's electronic workstation. Physicians may reference this summary before formal consultation to adjust their questioning focus, verify information accuracy, or supplement missing details. The physician's final written medical record serves as the primary evaluation object for this group.
Control Group
This group will exclude AI intervention entirely. Physicians will independently complete the consultation and documentation from scratch, serving as the baseline reference for evaluating AI system performance.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Concordance Rate Between AI-Generated Medical Records and Gold Standard
時間枠:From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Proportion of AI-generated "Case Characteristics" summaries that match the gold standard (established by expert panels) in key diagnostic elements (e.g., symptom description, risk factors, physical findings).
From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Diagnostic Accuracy of Physician Documentation With AI Summary Reference
時間枠:From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Proportion of physician-completed medical records in Experimental Group 2 that meet predefined quality criteria (completeness, diagnostic relevance, alignment with gold standard).
From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Proportion of physician medical records meeting predefined quality criteria without AI support
時間枠:From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Proportion of physician-completed medical records that meet predefined quality criteria (completeness, diagnostic relevance, alignment with gold standard) in the absence of AI assistance.
From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Average physician consultation duration
時間枠:From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Comparison of average consultation times across study groups.
From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Average pre-consultation preparation time for physicians
時間枠:From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Time spent by physicians reviewing AI-generated case summaries before consultation.
From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Patient satisfaction measured by validated questionnaires
時間枠:From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Patient-reported experience measured via validated satisfaction questionnaires. Scores range from 0 to 100; higher scores indicate greater satisfaction, assessing ease of AI interaction and perceived care quality.
From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Physician satisfaction with AI workflow
時間枠:From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Physician survey evaluating perceived efficiency, usability, and clinical utility of AI tools. Survey scores range from 0 to 100; higher survey scores represent better satisfaction with the AI system.
From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Frequency of AI-related adverse events and workflow disruptions
時間枠:From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
Documentation of AI-related errors, workflow disruptions, or safety concerns. Count of participants experiencing safety or workflow issues.
From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
System Usability Scale (SUS) scores for the AI interface
時間枠:From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days
System Usability Scale (SUS) is a standardized usability questionnaire; total score ranges from 0 to 100. Higher SUS scores correspond to better perceived usability of the AI interface, completed by physicians and patients.
From enrollment through completion of the index outpatient visit and chart assessment, assessed up to 7 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディチェア:ding yuan, doctor、Second Affiliated Hospital, School of Medicine, Zhejiang University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月15日

一次修了 (推定)

2026年11月30日

研究の完了 (推定)

2026年11月30日

試験登録日

最初に提出

2026年3月4日

QC基準を満たした最初の提出物

2026年7月15日

最初の投稿 (実際)

2026年7月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月21日

QC基準を満たした最後の更新が送信されました

2026年7月15日

最終確認日

2025年12月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2025-1371

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Patient Privacy and Confidentiality:

IPD contains sensitive personal health information (e.g., medical history, genetic data, diagnostic results), which could risk re-identification even after anonymization. Sharing such data might violate ethical obligations under the Declaration of Helsinki and local regulations (e.g., GDPR, HIPAA).

Informed Consent Limitations:

Participants provided consent for data use within the scope of this specific study. Broad sharing of IPD for secondary purposes (e.g., unrelated research) was not explicitly authorized in the consent process, raising ethical and legal concerns.

Data Ownership and Governance:

Data may be governed by institutional or national policies restricting external access (e.g., Chinese data sovereignty laws). Sharing IPD could conflict with agreements between the study sponsor, healthcare providers, and regulatory bodies.

Risk of Misinterpretation:

Contextual or methodological details critical to interpreting IPD (e.g., AI system workfl

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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