The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection

The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection (ESD): a Multicenter, Randomized Controlled Trial

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:

1. Does the AI system shorten the time it takes to stop each bleed during ESD?
2. How does the AI system affect the rate of surgery-related problems and total surgery time?

Researchers will compare two groups to see if the AI system improves hemostasis efficiency:

1. AI group: During ESD, the AI system will real-time spot and mark bleeding points. Doctors will use these marks to stop bleeding.
2. Control group: Doctors will use the same equipment but without the AI system - they will find and stop bleeding using their own experience.

Participants will:

1. Have ESD surgery for esophageal, stomach, or colorectal lesions that need this treatment;
2. Be randomly assigned to either the AI group or the control group;
3. Attend follow-up checks in 14 days after surgery to check for complications;
4. Have their surgery videos reviewed by experts to record hemostasis time and total surgery time.

Study Overview

• Status: Not yet recruiting
• Conditions: Endoscopic Submucosal Dissection; Endoscopic Submucosal Dissection (ESD)
• Intervention / Treatment: Device: AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen Li; Phone Number: +86-18560086106; Email: qilulizhen@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Aged 18-80 years;
2. Lesions meet the indications for ESD treatment of the esophagus, stomach, or colorectum according to relevant guidelines;
3. Anticoagulant drugs have been suspended according to relevant guidelines;
4. Patients with American Society of Anesthesiologists (ASA) classification Grade I or II;
5. Patients who voluntarily sign the informed consent form.

Exclusion Criteria

1. Patients with severe cardiopulmonary diseases, coagulation dysfunction or other severe comorbidities that may increase surgical risks;
2. Patients undergoing dialysis treatment;
3. Pregnant or lactating women;
4. Deemed unsuitable for participation in this study by the principal investigator or other researchers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-assisted Group; 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.	Device: AI real-time assistance in endoscopic submucosal dissection (ESD) for bleeding spot identification and marking; 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.
No Intervention: Conventional treatment group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average single hemostasis time	Periprocedural

Secondary Outcome Measures

Outcome Measure	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		Periprocedural
Psychological stress experienced by the endoscopist	Be evaluated subjectively on a five point scale	Periprocedural

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: Qianfoshan Hospital; Shandong Second Provincial General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection; Artificial intelligence
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Endoscopic Mucosal Resection
• Other Study ID Numbers: 2026SDU-QILU-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No