Multimodal Endoscopic Image Fusion for Assessing Infiltration in Superficial Esophageal Squamous Cell Carcinoma

NCT ID: NCT06412419

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2024-10-30

Brief Summary

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The objective of this project is to pioneer a novel protocol for the adjunctive screening of early-stage esophageal cancer and its precancerous lesions. The anticipated outcomes include simplifying the training process for users, shortening the duration of examinations, and achieving a more precise assessment of the extent of esophageal cancer invasion than what is currently possible with ultrasound technology. This research endeavors to harness the synergy of endoscopic ultrasound (EUS) and Magnifying endoscopy, augmented by the pattern recognition and correlation capabilities of artificial intelligence (AI), to detect early esophageal squamous cell carcinoma and its invasiveness, along with high-grade intraepithelial neoplasia. The overarching goal is to ascertain the potential and significance of this approach in the early detection of esophageal cancer.

The project's primary goals are to develop three distinct AI-assisted diagnostic systems:

An AI-driven electronic endoscopic diagnosis system designed to autonomously identify lesions.

An AI-based EUS diagnostic system capable of automatically delineating the affected areas.

A multimodal diagnostic framework that integrates electronic endoscopy with EUS to enhance diagnostic accuracy and efficiency.

Detailed Description

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The study was executed in two distinct phases. The initial phase, designated as the modeling phase (Phase 1), involved a retrospective analysis of eligible subjects from a consortium of medical institutions, including the First Affiliated Hospital of Naval Medical University, West China Hospital of Sichuan University, Provincial Hospital Affiliated to Shandong First Medical University, the First Affiliated Hospital of Soochow University, the First Affiliated Hospital of Henan University of Science and Technology, and the First Affiliated Hospital of Shihezi University, all selected prior to January 1, 2024. The second phase, known as the real-world evaluation phase (Phase 2), prospectively enrolled consecutive patients who were scheduled to undergo magnometric endoscopy and EUS at the aforementioned hospitals between April 2024 and June 2024.

Conditions

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Esophageal Neoplasms Malignant

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Low-grade intraepithelial neoplasia of esophageal squamous epithelium

Magnifying Endoscopy and Endoscopic Ultrasonography

Intervention Type DIAGNOSTIC_TEST

The acquired magnifying endoscopy and endoscopic ultrasonography images were shared with artificial intelligence for machine learning, diagnostic modeling and optimization. In the real world evaluation phase, the high-risk population of early esophageal cancer who planned to undergo esophageal electronic endoscopy were prospectively enrolled. The artificial intelligence-assisted diagnosis system was used for prediction before surgery, and the postoperative pathological results were used as the gold standard to diagnose by grouping.

High-grade intraepithelial neoplasia of esophageal squamous epithelium

Magnifying Endoscopy and Endoscopic Ultrasonography

Intervention Type DIAGNOSTIC_TEST

The acquired magnifying endoscopy and endoscopic ultrasonography images were shared with artificial intelligence for machine learning, diagnostic modeling and optimization. In the real world evaluation phase, the high-risk population of early esophageal cancer who planned to undergo esophageal electronic endoscopy were prospectively enrolled. The artificial intelligence-assisted diagnosis system was used for prediction before surgery, and the postoperative pathological results were used as the gold standard to diagnose by grouping.

Stage T1a esophageal squamous cell carcinoma

Magnifying Endoscopy and Endoscopic Ultrasonography

Intervention Type DIAGNOSTIC_TEST

The acquired magnifying endoscopy and endoscopic ultrasonography images were shared with artificial intelligence for machine learning, diagnostic modeling and optimization. In the real world evaluation phase, the high-risk population of early esophageal cancer who planned to undergo esophageal electronic endoscopy were prospectively enrolled. The artificial intelligence-assisted diagnosis system was used for prediction before surgery, and the postoperative pathological results were used as the gold standard to diagnose by grouping.

Stage T1b esophageal squamous cell carcinoma

Magnifying Endoscopy and Endoscopic Ultrasonography

Intervention Type DIAGNOSTIC_TEST

The acquired magnifying endoscopy and endoscopic ultrasonography images were shared with artificial intelligence for machine learning, diagnostic modeling and optimization. In the real world evaluation phase, the high-risk population of early esophageal cancer who planned to undergo esophageal electronic endoscopy were prospectively enrolled. The artificial intelligence-assisted diagnosis system was used for prediction before surgery, and the postoperative pathological results were used as the gold standard to diagnose by grouping.

Interventions

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Magnifying Endoscopy and Endoscopic Ultrasonography

The acquired magnifying endoscopy and endoscopic ultrasonography images were shared with artificial intelligence for machine learning, diagnostic modeling and optimization. In the real world evaluation phase, the high-risk population of early esophageal cancer who planned to undergo esophageal electronic endoscopy were prospectively enrolled. The artificial intelligence-assisted diagnosis system was used for prediction before surgery, and the postoperative pathological results were used as the gold standard to diagnose by grouping.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Patients requiring magnifying endoscopy and endoscopic ultrasonography. Individuals of either sex, aged 18 years or older.

Exclusion Criteria

Inability to complete esophageal electronic endoscopy. Absence of biopsy or surgery, resulting in unobtainable pathological results. Patients who have undergone endoscopic lesion destruction or piecemeal resection, preventing the acquisition of an en bloc resection sample.

Patients with significant endoscopic, imaging, or pathological evidence of advanced esophageal cancer.

Patients presenting with marked esophageal stenosis or dilatation. Individuals with a history of other malignancies. Patients who have received neoadjuvant radiotherapy. Patients who declined to participate in the study and did not provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Henan University of Science and Technology

OTHER

Sponsor Role collaborator

THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY

UNKNOWN

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luowei Wang

Role: STUDY_CHAIR

Changhai Hospital

Locations

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Changhai hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Luowei Wang

Role: CONTACT

86-21-31161337

Facility Contacts

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Han Lin

Role: primary

Other Identifiers

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MEIFI-sESCC

Identifier Type: -

Identifier Source: org_study_id

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