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| Name | Class |
|---|---|
| Qianfoshan Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
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The goal of this clinical trial is to learn if an artificial intelligence (AI) system that identifies bleeding points in real time can help stop bleeding faster during endoscopic submucosal dissection (ESD) - a minimally invasive surgery for early digestive tract cancer or precancerous lesions. It will also learn about the AI system's effect on surgery-related problems (like perforation or delayed bleeding) and total surgery time.
The main questions it aims to answer are:
Researchers will compare two groups to see if the AI system improves hemostasis efficiency:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-assisted Group | Experimental | During the endoscopic submucosal dissection (ESD) procedure, an artificial intelligence (AI) real-time bleeding point recognition system is utilized. The system dynamically analyzes endoscopic images to identify and mark bleeding sites in real time. Endoscopists perform hemostatic operations promptly based on these AI-generated markers. |
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| Conventional treatment group | No Intervention | Patients undergo ESD using the same hardware platform, but the AI system is deactivated. Hemostatic decisions and operations are solely dependent on the endoscopists' clinical experience-they independently judge the location of bleeding points and perform hemostasis without AI assistance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking | Device | Patients undergo ESD with real-time AI assistance. During the operation, the pre-trained and validated AI system continuously analyzes endoscopic images to automatically identify and mark active bleeding points in real time. Endoscopists perform hemostatic operations (e.g., coagulation with hemostatic forceps or electrosurgical knives) based on the AI-generated marks to target bleeding sites promptly. |
| Measure | Description | Time Frame |
|---|---|---|
| Average single hemostasis time | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative complications | Complications include intraoperative and postoperative perforation, damage to the muscularis propria, etc | 14 days post-procedure |
| Total operation duration |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Li | Contact | +86-18560086106 | qilulizhen@sdu.edu.cn |
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|
| Periprocedural |
| Psychological stress experienced by the endoscopist | Be evaluated subjectively on a five point scale | Periprocedural |
| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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